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April 2009
X-Ray Inspection System Designed For Quality Control In A HACCP Plan
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February 2009
Amylin Shares Rise As Icahn Raises Stake
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Bayer Schering Pharma To Open Beijing R&D Center
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Biogen Idec 4Q Profit Grew 3 %
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Bristol-Myers Stock Jumps On Takeover Speculation
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Cephalon Linked To Indicted Kansas Doctor
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Debate On North Dakota Pharmacy Bill Takes On Edge
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Dr. D. Gary Gilliland, Internationally-Recognized Physician and Researcher, Joins Merck Research Labs as Head of Oncology Research
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Drug Maker Sentenced For Illegal Imports
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FDA Approves Clinical Studies Of A Novel Anti-Cancer Drug Developed By Italian Researchers
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FDA Approves KAPIDEX Delayed Release Capsules For The Treatment Of GERD
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FDA Approves ULORIC(R) (febuxostat) for the Chronic Management of Hyperuricemia in Patients With Gout
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FDA Delays Decision On J&J Drug For Mood Disorder
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FDA Extends Review Time For Gout Drug
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FDA Probes Lilly Blood-Poisoning Treatment
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FDA Reviewing Lilly’s Blood Thinner Prasurgel
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FDA Seeks Plans To Reduce Misuse Of Painkillers
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Federal Trade Commission Files Complaint Against Par Pharmaceutical Over Court-Approved AndroGel(R) Litigation Settlement
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Galderma Wins FDA Approval for Vectical Ointment, a Novel Topical Therapy for Psoriasis
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Germany's Merck Reports 4Q Loss Of euro279.5 Million
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GlaxoSmithKline 4Q Profit Falls, Confirms Job Cuts
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GTx's Bone Fracture Drug Under FDA Review
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Headline Unavailable
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Huge Study Boosts Disappointment On Multivitamins
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Human Genome Sciences Begins Delivery of First-in-Class Anthrax Treatment to U.S. Strategic National Stockpile
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Ireland's Elan Trims Losses As MS Drug Sales Surge
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J&J Seeks Full FDA Approval For HIV Treatment
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KV Pharmaceutical Company Reduces Workforce
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La Jolla And BioMarin Stop Riquent Trial
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MDRNA, Inc. Announces Licensing Agreement With Roche
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Merck Will Buy Insmed Biosimilars For $130 million
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Novartis May Pay More Than $575M For Blood Thinner
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Novogen To Focus On Oncology Program
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Official: Sebelius Near Top For Health Post
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Oregon Attorney General: Bayer Settling Ad Case For $20 Million
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Pfizer Cancer Drug Gets Nod In UK Recommendation
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Pfizer Discontinues Global Phase III Trial of Axitinib for Futility in Advanced Pancreatic Cancer
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Pfizer To Disclose Payments To Doctors Next Year
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Prasugrel Receives Unanimous Approval Recommendation From FDA Advisory Committee
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Report: Extavia's Launch Foreshadows Novartis' Future Intentions in the Multiple Sclerosis Market
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Report: Glaxo To Cut Prices For Poor Countries
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Reports: GlaxoSmithKline To Cut Thousands Of Jobs
|
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Roche CEO: Offer For Genentech A Fair Deal
|
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Roche Launches $86.50-A-Share Bid For Genentech
|
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Roche Says Full-Year Net Income Down 5 Percent
|
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|
Sandoz Accused By Alabama Of Overpricing
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Sanofi Pasteur Dengue Vaccine Enters Pediatric Efficacy Clinical Study
|
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Sanofi-aventis 4Q Profit Sinks 76% On Charge
|
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Sanofi-aventis Appoints Jean-Pierre Lehner Chief Medical Officer
|
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Schering-Plough Swings To 4Q Profit
|
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Trial To Begin In Lawsuit Against Drug Company
|
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USP Proposes Strengthened Partnership With HHS, FDA, To Help Protect Patients and Consumers
|
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|
Vical Reports Positive Bird Flu Vaccine Trial Data
|
|
|
Warner Chilcott Announces Agreement to Acquire Topical Alprostadil Treatment for Erectile Dysfunction
|
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|
Wisconsin Attorney General Hails Major Victory Against Pfizer Unit
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Wyeth Deal Could Mean NJ Drug Industry Job Cuts
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January 2009
Abbott Opens New Pharmaceutical Research Laboratory in Singapore
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Actavis Receives Approval of Levetiracetam Oral Solution in the U.S.
|
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Actavis To Shut Down Plants Until Issues Fixed
|
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Akrimax Pharmaceuticals Announces Manufacturing Partnership
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Amgen 4Q Profit Rises 15 Percent On Lower Costs
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|
AMRI Appoints Director of Global Project Management
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|
AMRI Names Senior Director, Analytical and Quality Services
|
|
|
Apicore LLC Announces the Second Successful Inspection by FDA of Its Active Pharmaceutical Ingredient (API) Site in Somerset, New Jersey
|
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|
AtheroGenics Provides Update on Bankruptcy Proceedings
|
|
|
AvivoClin’s Expansion Continues with the Addition of Microdosing and Central Lab Services
|
|
|
Baxter 4Q profit up 19 percent on plasma sales
|
|
|
Bio Nano Consulting To Provide Specialist Nanotech Product Development Services
|
|
|
BioMarin and La Jolla Pharmaceutical Sign Worldwide (Excluding Asia Pacific) Development and Commercialization Agreement for Riquent
|
|
|
Biotica Strikes Significant Collaboration Deal With GlaxoSmithKline
|
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|
Boehringer Ingelheim Appoints Albert Ros as Executive Vice President of Sales and Marketing for Prescription Medicines
|
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|
Celestial Biologicals Collaborates With GE Healthcare To Set Up India’s First Fully Integrated Chromatography-Based Plasma Fractionation Facility
|
|
|
Cell Therapeutics Receives $7.5 Million Under Joint Venture Agreement With Spectrum Pharmaceuticals
|
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|
Clinical Trial Service Provider Enhances Services
|
|
|
Collegium Pharmaceutical Announces FDA Approval of AllerNaze™, a Nasal Inhaled Steroid for the Treatment of Allergic Rhinitis
|
|
|
CRIX, Pfizer, Partners HealthCare and CDISC Exploring Ways to Improve Patient Safety
|
|
|
CV Therapeutics Will Review Astellas Offer Again
|
|
|
Depomed’s License Agreement With Solvay Pharmaceuticals Clears HSR Review
|
|
|
DOR BioPharma Receives SPA Clearance From the FDA to Begin Confirmatory Phase 3 Clinical Trial of orBec(R) in GI GVHD
|
|
|
Dr. Derek Winstanly of Quintiles to Serve as 2009 ACRO Chair; Mr. William Sharbaugh of PPD to Be Chair-Elect; ICON Joins as Associate Member
|
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|
Drug Developers Looking to Learn as Much as Possible in Phase I Trials, According to Tufts Center for the Study of Drug Development
|
|
|
Drug From Genetically Engineered Goats A First
|
|
|
Eden Biodesign Appoints New Director To Spearhead Drive Into Us Project Management
|
|
|
Elan Hires Outside Adviser To Review Options
|
|
|
Eli Lilly Faces FDA Delay On Schizophrenia Drug
|
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|
Eli Lilly Reports 4Q Loss On ImClone Costs
|
|
|
Families Extend Agreement On Roche Shares
|
|
|
FDA Advisory Committee Unanimously Recommends Sabril® (vigabatrin) for the Treatment of Two Catastrophic Epilepsies
|
|
|
FDA Approves Drug For Patients With Advanced Prostate Cancer
|
|
|
FDA Approves Mylan's Generic Version Of Prilosec
|
|
|
FDA Backs Vytorin After Finishing Study Review
|
|
|
FDA Issues Complete Response Letter to SCOLR Pharma's Abbreviated New Drug Application for CDT(R) 12-Hour Pseudoephedrine
|
|
|
FDA May Miss Researchers' Financial Conflicts
|
|
|
FDA OKs Sharing Unapproved Drug Uses With Docs
|
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FDA Probe Finds No Link With Asthma Drugs, Suicide
|
|
|
FDA Reviews Benefits Of Plavix In Certain Patients
|
|
|
Galapagos and GlaxoSmithKline Expand Anti-Infectives Alliance
|
|
|
Galderma Announces Availability of Epiduo(TM) Gel
|
|
|
Genta Receives Orphan Drug Designation in Gastric Cancer for Tesetaxel, a Leading Oral Taxane in Clinical Development
|
|
|
GlaxoSmithKline Pennsylvania Plant To Be Vaccine Hub
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|
|
GlaxoSmithKline Takes $400 Million Legal Charge
|
|
|
Halo Pharmaceutical, Inc. Acquires Whippany, NJ Manufacturing Facility from Abbott
|
|
|
Humira Sales Lift Abbott 4Q Profit 28 Percent
|
|
|
IMPAX Labs Confirms Patent Challenge Relating to Amrix(R) Extended-Release Capsules
|
|
|
Inspire Initiates Phase 3 ProlacriaT Dry Eye Trial under Special Protocol Assessment Agreement With FDA
|
|
|
J&J Unit Recalls Pain Patches Over Defect
|
|
|
Johnson & Johnson 4Q Profit Rises 14 Percent
|
|
|
Kevin Buehler Appointed President and CEO of Alcon; Cary Rayment to Continue as Chairman of the Board
|
|
|
Kuwait Purchases 5.4 Million Doses of Emergency Nuclear Radiation Drug
|
|
|
Lilly Announces Senior Leadership Change
|
|
|
Lilly Settles Zyprexa Suit For $1.42 Billion
|
|
|
Medarex says FDA Approves Testing Of Cancer Drug
|
|
|
Merck Seeks Gardasil Approval For Bboys
|
|
|
Merck: New Pill May Work For MS
|
|
|
Mylan Receives Final FDA Approvals for Generic Versions of Lamictal(R) Tablets
|
|
|
NovaBay Appoints Harry F. Hixson, Jr., PhD, Former Amgen President/Chief Operating Officer to Its Board of Directors
|
|
|
Novartis Posts 62 % Rise In 4Q Net Profit
|
|
|
Novartis To Build $486M Plant In North Carolina
|
|
|
Novo Nordisk Posts 138 Percent Rise In 4Q Profits
|
|
|
Outsourcing Building as Global Economy Slides into Deeper Recession
|
|
|
PDL BioPharma, Alexion Settle Patent Dispute
|
|
|
Perrigo Company Appointed Generic Distributor by Medimetriks Pharmaceuticals
|
|
|
Pfizer Contributes Critical Data to URMC Drug Safety Initiative
|
|
|
Pfizer Cutting Up To 800 Scientist Jobs
|
|
|
Pfizer Tells Financial Times - Still Open To Purchases
|
|
|
Pfizer To Buy Wyeth For $68 Billion, Cut Jobs
|
|
|
Pfizer: US Ruling Maintains Lipitor Patent Term
|
|
|
Pharmaceutical Corporation and Cytovance Biologics Sign Deal for the Process Development and cGMP Manufacture of Selexys Pharmaceutical Corporation's Product HPL1 Monoclonal Antibody (Mab)
|
|
|
Pharmatech Launches New Solid Dose Division
|
|
|
Plavix Sales Help Bristol-Myers Swing To Q4 Profit
|
|
|
PPD Buys Merck Facility, Enters Testing Contract
|
|
|
PPD Enters Into Strategic Collaboration with Merck
|
|
|
Pricing, regulation squeezed drug industry in 2008
|
|
|
Prism Pharmaceuticals Receives FDA Approval of NEXTERONE
|
|
|
Quanticate Appoints Andrew MacGarvey to President of U.S. Operations Signaling Further Expansion of CRO Services
|
|
|
Recipharm Launches Into Biologics Manufacturing
|
|
|
Report Warns of Risks of Anti-Innovation Forces Infiltrating European Commission: EU Witch Hunt Focuses on Pharmaceutical Product Lifecycle Management
|
|
|
Report: Growth In Calif.'S Biomed Industry Stalls
|
|
|
Review of Takeda's Febuxostat New Drug Application Continues Past PDUFA Date - FDA has not completed routine investigator site and CRO vendor inspections
|
|
|
Schering-Plough Says FDA Wants More Saphris Data
|
|
|
Settlement Limits Insurers' Claims In Vioxx Deal
|
|
|
SRI International Partners With AuricX Pharmaceuticals on Oral Formulations of Vancomycin Antibiotic
|
|
|
Stem Cell Human Trials Planned
|
|
|
Stephen W. Sanger Elected to Pfizer's Board of Directors
|
|
|
Studies: Steroids Do Not Help Wheezing Kids
|
|
|
Study Adds To Evidence Of Vaccine Safety
|
|
|
Synta To Develop Anti-Inflammatory Drugs For Roche
|
|
|
Tekmira Announces $11.2 Million 3-Year Manufacturing and Development Commitment From Partner Alnylam
|
|
|
Teva, Lonza In Venture To Copy Biotech Drugs
|
|
|
Valeant Closes Dow Pharmaceutical Buyout
|
|
|
Warner Chilcott and Watson Pharmaceuticals Announce Agreements on Loestrin(R) 24 and Femcon(R) Fe Patent Litigation
|
|
|
Will Pfizer Buy Wyeth?
|
|
|
World's Highest Drug Levels Entering India Stream
|
|
|
Wyeth Exec: Nontraditional Products Fueling Growth
|
|
|
Wyeth Pharmaceuticals and Santaris Pharma Announce Strategic Alliance to Develop RNA-based Medicines
|
|
|
XDx and Bristol-Myers Squibb Enter into Pharmacogenomics Collaboration
|
|
|
December 2008
3M Licenses Dry Powder Inhaler Technology From Cambridge Consultants
|
|
|
AAIPharma and CORTRIA Corporation Sign Drug Delivery Deal
|
|
|
Agios Pharmaceuticals Expands Into 21,000 sq. ft. Facility
|
|
|
Alkermes Regains Full Commercialization Rights to VIVITROL® in US
|
|
|
AstraZeneca Awards Infosys Technologies Multi-Year, Multi-Million Dollar Global Services Deal
|
|
|
AstraZeneca Extends Diabetes Drug Plans To Japan
|
|
|
AstraZeneca Responds to FDA Joint Advisory Committees' Recommendation on SYMBICORT(R)
|
|
|
AstraZeneca Says FDA Asks For Seroquel Detail
|
|
|
Bio-Imaging Technologies Partners With Ag Mednet To Offer Complete Imaging Solution For Clinical Trials
|
|
|
Bristol-Myers, Biotech Exelixis Team Up On Cancer Drug
|
|
|
Covidien Ltd. Announces Proposed Change in Incorporation
|
|
|
Dr. John E. Strell Joins Octapharma USA as Vice President of Medical Affairs
|
|
|
Dr. Reddy’s Announces Settlement of Clarinex® (Desloratadine) ANDA Patent litigation With Schering Corporation and Sepracor Inc.
|
|
|
Dr. Reddy’s Launches Authorized Generic Version of Imitrex Tablets
|
|
|
Elan, Biogen Report New Tysabri Brain Disease Case
|
|
|
Eli Lilly Joins SAFE-BioPharma Association
|
|
|
Enzon Discontinues Its Plan to Spin-off Its Biotechnology Business
|
|
|
Exelixis and Bristol-Myers Squibb to Co-Develop XL413, a Selective Cdc7 Inhibitor
|
|
|
FDA Advisers: Restrict Some Asthma Drugs
|
|
|
FDA Advisory Committee Recommends Approval of Bausch & Lomb Besifloxacin Anti-Infective Eye Drop
|
|
|
FDA Advisory Committee Unanimously Recommends Approval of Genzyme’s Synvisc-One
|
|
|
FDA Announces Permanent Injunction Against Wilderness Family Naturals LLC
|
|
|
FDA Approves Adult Use Of Glaxo Vaccine Boostrix
|
|
|
FDA Approves Drug that Boosts Stem Cell Yield for Bone Marrow Transplants
|
|
|
FDA Approves Gleevec to Prevent Recurrence of Rare Gastrointestinal Cancer
|
|
|
FDA Approves New Drug to Alleviate Moderate to Severe Pain
|
|
|
FDA Commissioner To Resign January 20th
|
|
|
FDA Commissioner To Resign January 20th
|
|
|
FDA Grants Pralatrexate Orphan Drug Designation for the Treatment of Patients with Follicular Lymphoma
|
|
|
FDA Requires New Safety Measures for Oral Sodium Phosphate Products to Reduce Risk of Acute Kidney Injury
|
|
|
FDA Teams With WebMD For New Online Consumer Health Information
|
|
|
FDA Warns Consumers About Tainted Weight Loss Pills
|
|
|
FDA: Novartis Malaria Pill Shows Superior Results
|
|
|
Genta to Appeal FDA Decision on New Drug Application for Genasense® in Patients with Chronic Lymphocytic Leukemia
|
|
|
Gilead Sciences Files Patent Infringement Lawsuit Against Teva
|
|
|
Glaxo To Buy Bristol-Myers Squibb Pakistan
|
|
|
GlaxoSmithKline and Archemix Form Strategic Alliance to Develop Aptamers to Treat Inflammatory Diseases
|
|
|
GlaxoSmithKline Extends Tender Offer For Genelabs
|
|
|
Hovione Buys Pfizer's Loughbeg API Facility
|
|
|
IMS Health Reports Annual Global Generics Prescription Sales Growth of 3.6 Percent, to $78 Billion
|
|
|
Isogen Retains Strategic Partner Sheridan Road Financial to Meet Global Biopharma Demand
|
|
|
JLL Partners Bids US$2.00 Per Share For Drugmaker Patheon
|
|
|
John Hendrix Named Program Director, Member & Vendor Relations, SAFE-BioPharma Association
|
|
|
Lilly Withdraws Application for Additional U.S. Indication for Cymbalta for Chronic Pain
|
|
|
MannKind's Inhaled Insulin Trials Meet Their Goals
|
|
|
Merck 2009 Profit Outlook Misses Estimates
|
|
|
Merrion Announces License Agreement With Novo Nordisk to Develop Oral Formulation of Insulin Analogues
|
|
|
Nutra Pharma Receives Clinical Drug Supply Contract
|
|
|
Octapharma Names Dennis D. Curtin To Lead U.S. Plasma Operations
|
|
|
Perrigo, Schering-Plough Settle Clarinex Suit
|
|
|
Pfizer Again Tops Annual “Most Effective” Sales Force Ranking, According to Study
|
|
|
Pfizer And Novocell Announces A Non-Exclusive Drug Discovery Collaboration
|
|
|
Pfizer And Sangamo BioSciences Announces License Agreement For Zinc Finger Nucleases For Protein Production
|
|
|
PPD to Expand Contract Research Operations into Ireland
|
|
|
PRA International Announces Collaboration With Frontage Laboratories Inc.
|
|
|
PricewaterhouseCoopers Identifies the Top Nine Issues for Health Industries in 2009
|
|
|
Quintiles Acquires Targeted Molecular Diagnostics
|
|
|
Report Finds Economic Crisis Hurting U.S. Preparedness for Health Emergencies; More Than Half of States Score 7 or Lower Out of 10 in Readiness Rankings
|
|
|
Roche and FDA Agree on Pathway Towards U.S. Approval of ACTEMRA(R) (tocilizumab
|
|
|
Sanofi-Aventis And Bristol-Myers Squibb Prevail Before The U.S. Court Of Appeals For The Federal Circuit In The U.S Plavix® Patent Infringement Case
|
|
|
Sanofi-Aventis To Cut US Sales Jobs
|
|
|
Sanofi-aventis U.S. Announces Increased Access to Drugs for Low Income
Patients Through Expanded PAP Programs
|
|
|
Schering Says Cholesterol Drug Sales Falling Again
|
|
|
Schering-Plough Touts Pipeline Over Competitors'
|
|
|
SDI Reports: Number of Flu Vaccines Given in Physicians’ Offices Lower This Season
|
|
|
Synta Earns $15 Million from GlaxoSmithKline for Achieving Elesclomol Milestones
|
|
|
Teva Announces Agreement on Generic Pulmicort Respules Patent Challenge
|
|
|
Teva Completes Acquisition of Barr
|
|
|
Titan Pharmaceuticals Announces Further Reductions in Workforce and Voluntary Delisting from the American Stock Exchange
|
|
|
Titan Pharmaceuticals Announces Reduction in Force
|
|
|
U.S. Department of Defense Chooses Phase Forward to Support FDA-Sponsored Drug Safety Initiative
|
|
|
Valeant to Acquire Dow Pharmaceutical Sciences, Inc. for $285 Million
|
|
|
Watson Pharmaceuticals Receives FDA Final Approval for Generic Wellbutrin XL(R) 150 mg
|
|
|
November 2008
AAIPharma Strengthens Global Clinical Development Services Unit With Addition Of Two Executives
|
|
|
Abbott Labs Announces $184 Million In Settlements
|
|
|
Actavis Opens Research and Development Labs in Florida
|
|
|
Akorn Enters into a Five Year Contract Manufacturing Agreement to Supply Ophthalmic Product
|
|
|
Akorn-Strides, LLC Announces FDA Approval for Pamidronate Disodium Injection
|
|
|
AMRI Announces Agreement with Teva Pharmaceuticals and Barr Laboratories to Settle Litigation in ALLEGRA® and ALLEGRA®D-12 U.S. Patent Dispute
|
|
|
AnaSpec Establishes New Dedicated GMP Manufacturing Facility
|
|
|
Avid Bioservices Expands Capabilities With Installation of Single-Use Bioreactor Systems
|
|
|
Barr Shareholders Approve Pending Teva Acquisition
|
|
|
BASi Opens New Office in Europe to Better Serve Pharmaceutical and Biotech Companies
|
|
|
Baxter Receives Frost & Sullivan’s 2008 North American Customer Service Leadership of the Year Award
|
|
|
Bilcare GCS Expands Pre-Clinical and Early-Stage Development Capabilities
|
|
|
Carlos V. Paya, MD, PhD, to Join Elan as Company President
|
|
|
Charles River Promotes Foster Jordan to Corporate Senior Vice President
|
|
|
Consumers Warned Of FDA Impersonator Scam
|
|
|
CSI USA, Inc. Issues Voluntary National Recall of Topical Acne Cream
|
|
|
Daiichi Sankyo and ArQule Enter Into Strategic R&D Partnership to Progress Novel Compounds to Target Cancer
|
|
|
Drug Information Association (DIA) Opens New Office In China
|
|
|
Duska Therapeutics and DSM Pharmaceuticals in Manufacturing Collaboration for PSVT Drug Product
|
|
|
Eli Lilly Buys Majority of ImClone in Tender Offer
|
|
|
etrials Worldwide Names M. Denis Connaghan as Chief Executive Officer
|
|
|
FDA Acts to Avoid Shortage and Strengthen the Safety of Sucraid
|
|
|
FDA Approves BANZEL (rufinamide) as Adjunctive Treatment for Severe Epilepsy Disorder
|
|
|
FDA Approves Promacta(R) (Eltrombopag), the First Oral Medication to Increase Platelet Production for People With Serious Blood Disorder
|
|
|
FDA Approves Toviaz, a New Drug to Treat Overactive Bladder
|
|
|
FDA Awards Vangent $2.5 billion ICT21 Contract
|
|
|
FDA Reports Nationwide Recall of Mislabeled ReliOn Insulin Syringes
|
|
|
FDA Seizes Contaminated Heparin from a Cincinnati Manufacturer
|
|
|
Genentech Seeks Avastin Approval in Brain Cancer
|
|
|
GlaxoSmithKline Trimming US Sales Force By 1,000
|
|
|
Honeywell Signs Supply Agreement With Chinese Company For Aclar Film
|
|
|
ICON Opens Full Service Central Laboratory in India
|
|
|
ImClone Systems’ New Manufacturing Facility Receives FDA Approval for Multi-Product Biologics Production
|
|
|
Irvine Pharmaceutical Services Introduces New Fill-and-Finish Subsidiary
|
|
|
Isogen Launches Major New Facility to Address Global Biopharma Demand
|
|
|
Javelin Pharmaceuticals Announces 15 Percent Reduction in Workforce
|
|
|
Johnson and Johnson - Merck Consumer Pharmaceuticals Company Recalls Mylicon Gas Relief Dye Free Drops Non-Staining Due To Possible Metal Fragments
|
|
|
Kirby Lester Adds Healthcare Industry Veteran Bradley Stewart to R&D Position
|
|
|
Laureate Pharma Honored As Emerging Life Sciences Company Of The Year
|
|
|
Metrics Inc. Opens Larger Scale Manufacturing Facility
|
|
|
METTLER TOLEDO Safeline Expands Product Test Lab
|
|
|
Millipore and Applikon Biotechnology Form Collaboration to Expand Offerings in Fast-Growing Disposable Manufacturing Market
|
|
|
Mylan Receives Final Approval for First-to-File Generic Version of Antiepileptic Keppra(R) and Launches Immediately
|
|
|
National Drug Development Accelerator Launched
|
|
|
Par Pharmaceutical Begins Shipment of Budesonide Inhalation Suspension
|
|
|
Patheon Establishes European Headquarters in Switzerland
|
|
|
Patient Recruitment Begins in India for Phase 3 Diabetes Trial
|
|
|
PDL BioPharma Names McLaughlin as Future CEO
|
|
|
Pfizer Discontinues Development Program for Its Phase 3 Obesity Compound
|
|
|
Pfizer Launches Global Regenerative Medicine Research Unit
|
|
|
Pfizer Puts Closed Terre Haute Plant Up For Sale
|
|
|
Pfizer Withdraws Application to Switch Viagra to Non-Prescription Status in Europe
|
|
|
Recipharm Enters Into Partnership With Astrazeneca For Swedish Biomanufacturing Facility
|
|
|
Russia Chooses Inactivated Polio Vaccine from Sanofi Pasteur for Primary Immunization of All Infants
|
|
|
Sartorius Stedim Biotech Acquires Wave Biotech AG
|
|
|
Study Confirms: The U.S. Remains Preferred Market for Launching New Drug Products
|
|
|
Study Finds Demand for Smoking Cessation Drugs Still Strong Despite Chantix’ Safety Issues
|
|
|
Study: Wider Cholesterol Drug Use May Save Lives
|
|
|
University of Iowa Service Divisions Merge to Become 'The University of Iowa Pharmaceuticals' and Announce the Formation of 'The University of Iowa Pharmaceuticals Development Consortium'
|
|
|
Wyeth Laying Off 118 Workers At Upstate NY Plant
|
|
|
Wyeth Names Michael Kamarck, President, Technical Operations & Product Supply
|
|
|
October 2008
3M and VaxInnate Collaborate to Develop Flu Vaccine Patch
|
|
|
3M Licenses Vaccine Adjuvants to Sanofi Pasteur
|
|
|
Abbott Receives Complete Response Letter From FDA for Controlled-Release Hydrocodone With Acetaminophen
|
|
|
Akorn, Inc. Announces FDA Approval of Akten(TM) Ophthalmic Gel 3.5%
|
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Akorn, Inc. Enters into a Commercial Manufacturing Supply Agreement
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Alnylam Earns $20 Million Payment from Takeda
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AMAG Pharmaceuticals Receives Complete Response Letter from FDA for Ferumoxytol
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Azopharma To Offer Microdosing Services
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Bridge Laboratories Awarded Major Contract to Support the National Institute on Drug Abuse (NIDA)
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Cardinal Tightens Drug Sales Oversight
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Catalent Pharma Solutions Announces First FDA Product Approval for Brussels Syringe Facility
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CEL-SCI Takes Delivery of New Manufacturing Facility
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Consortium Established to Promote Patient Safety and Reduce Medication Errors
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Daiichi Sankyo, Eli Lilly: New drug still on track
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Diabetes Treatment Guidelines Change; Lilly/Amylin To Benefit?
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Drug Industry Spends $13 Million On Thank-You Ads
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EPA Honors Pfizer for Reducing Greenhouse Gas Emissions
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ETHEX Corporation Voluntarily Recalls Three Lots of Dextroamphetamine Sulfate 5mg Tablets Due to the Potential for Oversized Tablets
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FDA and PATH Malaria Vaccine Initiative Announce Research Collaboration
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FDA Approves Duramed's LoSEASONIQUE(R) Oral Contraceptive
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FDA Awards NIPTE $1.19 Million Contract to Develop Quality by Design (QbD) Guidance Elements
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FDA Delays Decision On Abbott Cholesterol Drug
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FDA Grants Orphan Drug Status to Reata's RTA 402 for Treatment of Pancreatic Cancer
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FDA Issues Draft Guidance on Priority Review Vouchers
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FDA Issues Warning Letters to Bayer HealthCare for Illegally Marketing Two Unapproved Drugs
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FDA Licenses Drug to Prevent Joint Damage in Children with Hemophilia A
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FDA Licenses For Marketing New Therapy for Rare Genetic Disease
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FDA OKs Expanded Use of J&J Drug for HIV Patients
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FDA Panel To Vote On New Version Of Genzyme Drug
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FDA To Miss Review Deadline For PPD’s Alogliptin NDA
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FDA will open inspection office in China this year
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FDA, NCI, and CRIX International to Collaborate on FIREBIRD Pilot
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FDA’s Blood Products Advisory Committee intends to review the BLA for ATryn
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Forest, Cypress Face Delay In FDA Drug Review
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Heritage Introduces Propranolol Tablets
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ImClone Announces Merger Agreement with Eli Lilly at $70 Per Share
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IMS Health Forecasts 4.5 - 5.5% Growth for Global Pharmaceutical Market in 2009
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Johnson & Johnson Pharmaceutical Research & Development Submits NDA For Carisbamate
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King Pharmaceuticals Extends Tender Offer to Acquire Alpharma
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Lannett Announces Positive Results of Facilities Inspection
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Lannett Receives Patent Approval for Method of Manufacturing Certain Morphine Derivatives
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Laureate Announces Manufacturing Agreement with TolerX
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Lilly and Amylin Enter Into Supply Agreement for Exenatide Once Weekly
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Lilly Says EU Agency Opposes New Cymbalta Use
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Medelis Expands Worldwide CRO Services with New European Division Led by New Managing Director
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Medicines Co. Expects Year Loss On New Drug Cost
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Merck 3Q Net Drops 28 Percent; To Cut 7,200 Jobs
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Merck Dedicates Durham Vaccine Manufacturing Facility in Honor of Merck Scientist Maurice R. Hilleman, Ph.D.
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Millipore Opens New Manufacturing Facility in Ireland
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Neurotech Opens GMP Manufacturing Facility in Cumberland, Rhode Island
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Perrigo Licenses Prescription Brands to Medimetriks Pharmaceuticals
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Pfizer Names New Head of Clinical Development and Medical Affairs for Its Oncology Business Unit
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Pfizer Reaches Agreements in Principle to Resolve Litigation Involving Its NSAID Pain Medications
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Pharmatech Associates Leads Design for First FDA-licensed Biomanufacturing Facility in China
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Pozen Stock Tumbles As Patent Challenge Announced
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Reports of Serious Drug Reactions Hit Record
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Safety Concerns and Labeling Changes for Psoriasis Drug Raptiva
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Study Reports Companies Now Outsource Less Of Clinical Development Budget
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Study Reveals Clinical Trial Design Holds Key to Improved Drug Development Efficiency
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Study Reveals That Only 59% Of Pharma Companies Own Dedicated Compliance Departments
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Synta Earns $25 Million from GSK for Achieving Elesclomol Milestones
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Teva Announces FDA Approval and Commercial Launch of Fentanyl Transdermal System
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Valeant Pharmaceuticals Completes Acquisition of Coria Laboratories, Ltd.
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Valeant Received Upfront Payment From GSK
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VioPharma completes buy of Lev Pharmaceuticals
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WuXi PharmaTech Expands Collaboration for Fully Integrated Services
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September 2008
AAIPharma Appoints New Chief Operating Officer
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ACORN Contract Research Organization Appoints Tara Webb as Senior Director of CRO Business Development
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Alpharma Board Rejects King Pharmaceuticals' Unsolicited Tender Offer as "Financially Inadequate"
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Alpharma Urges Shareholders to Take No Action with Respect to King Pharmaceuticals' Announced Intent to Commence a Tender Offer
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Association of Clinical Research Organizations (ACRO) Welcomes Two New Member Companies
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AstraZeneca Receives Six Months Pediatric Exclusivity for CASODEX(R) from the FDA
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Bilcare GCS Expands Phase III Clinical Trial Service Capabilities
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Cardinal Health Plans to Spin Off Clinical and Medical Products Businesses
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Celator Pharmaceuticals Receives Orphan Drug Designation for Anticancer Agent CPX-351
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Cellexus Limited Acquires Assets of Cellexus Biosystems Plc and Forms New Management Team
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Dr. Reddy's Formally Announces its US Specialty Business, Promius Pharma, LLC.
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Dynavax Awarded $17 Million Contract from National Institutes of Health
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Emergent BioSolutions Signs Contract with BARDA/NIAID To Fund Development Of Next Generation Anthrax Vaccine
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|
Emerson Process Management Announces New Executive Appointments
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|
Encorium Group Signs $6.2 Million of New Contracts Mainly for Vaccines Clinical Trials
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|
Enobia Pharma Receives FDA Orphan Drug Designation for
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FDA Approves Expanded Uses for Gardasil
|
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FDA Approves Six Vaccines For The 2008-2009 Flu Season
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FDA Approves Treatment for Rare Neurologic Disease
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FDA Completes Audit of Azopharma’s Cyanta Analytical Laboratories Facility
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|
FDA Issues Warning Letters to Ranbaxy Laboratories Ltd., and an Import Alert for Drugs from Two Ranbaxy Plants in India
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FDA Launches New Web Sites On Medical Product Promotion
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|
FDA to Post Quarterly Report of Potential Safety Issues
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FDA Updates Health Information Advisory on Melamine Contamination
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|
FDA Warns Companies to Stop Marketing Unapproved Ophthalmic Balanced Salt Solution Drug Products and Topical Drug Products Containing Papain
|
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|
FDA: Manufacturers of TNF-Blocker Drugs Must Highlight Risk of Fungal Infections
|
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Genzyme Opens New Science Center
|
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|
Honeywell's Jack Bolick Earns Lifetime Achievement Award From Frost & Sullivan
|
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|
Indian Pharma Outsourcing Industry To Cross $2.5 bn By 2012
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|
MannKind Dedicates New Manufacturing
|
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|
Metrics VP Adds Pharm.D. To Professional Credentials
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|
NicOx Signs Agreement With Capsugel For The Manufacture of Naproxcinod Oral Capsules
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|
Norwich Pharmaceuticals Selects SupplyScape Nexus for Product Serialization
|
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|
NovaQuest Receives Lilly’s 'Global Sustained Supplier Award'
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|
Octagon Joins CDISC In Innovative Education Initiative For FDA Reviewers
|
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|
Roxane Laboratories, Inc. Launches Protriptyline HCl Tablets, USP
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|
Sun Pharma’s Generic Fosamax Tablets Approved
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|
Surefil Adds Third Production Line
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|
Teva and Barr Receive FTC Request for Additional Information
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|
Tris Pharma Completes Its Facilities' Expansion; Receives FDA Clearance
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|
UMass Lowell Opens New BioManufacturing Pilot Plant
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August 2008
AAI Pharma Appoints New Leader For N. American Biostatistics and Data Management Services
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|
Abbott Study Shows Investigational Heat-Stable Norvir(R) Tablet Provides Similar Drug Levels to Current Norvir Capsule
|
|
|
Analysis of Six Clinical Trials Finds EPZICOM(R) Effective in Treatment-Naive HIV Patients With Both High and Low Baseline Viral Loads
|
|
|
AstraZeneca Partners With Singapore Institutions to Develop Anti-Cancer Compounds
|
|
|
Azopharma Announces Additions to Clinical Research Services
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|
Banner Receives FDA Approval for Valproic Acid Delayed Release Softgel Capsules
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|
Bilcare GCS Opens New Global U.S. Headquarters
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|
BioDelivery Sciences Anticipates First Half 2009 Approval of BEMA™ Fentanyl (ONSOLIS™)
|
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|
BioSante Pharmaceuticals Reacquires Elestrin
|
|
|
Bristol-Myers Squibb Proposes to Acquire ImClone Systems
|
|
|
Cellectar, Inc. Begins GMP Production At Radiopharmaceutical Facility
|
|
|
Cholesterol Drug Plays Role in Melanoma Remission
|
|
|
Clinilabs Expands Phase I Facility
|
|
|
Covance And Eli Lilly Enter Into A Strategic R&D Collaboration
|
|
|
Covidien’s Mallinckrodt Baker Unit Signs Agreement With Rubicon Research for Performance Excipient Development
|
|
|
Eli Lilly And Phase Forward Extend Multi-Year Agreement
|
|
|
FDA Accepts Streamlined Phase 3 Development Plan for Q8003IR 'Dual Opioid' Pain Therapy
|
|
|
FDA Allows Phase 2 Study for Sound Pharmaceuticals' Novel Drug to Prevent Chemotherapy Induced Hearing Loss
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|
|
FDA Announces Improved Policies for Advisory Committees
|
|
|
FDA Approves 2008-2009 Flu Vaccines
|
|
|
FDA Approves First Drug for Treatment of Chorea in Huntington’s Disease
|
|
|
FDA Approves Nplate for Long-Term Treatment of Adult Chronic ITP
|
|
|
FDA Approves Vidaza Label Expansion
|
|
|
FDA Approves Viread(R) For Chronic Hepatitis B
|
|
|
FDA Grants IND for Pro-Pharmaceuticals' DAVANAT to Treat Breast Cancer Patient
|
|
|
FDA Issues Action Letter for Sugammadex
|
|
|
Fisher Scientific is Awarded 2008 Lilly Global Supplier Award
|
|
|
Generic Divalproex Sodium Approved By FDA
|
|
|
GSK Begins Shipments of Fluarix(R) and FluLaval(R) to U.S. Customers for 2008-2009 Influenza Season
|
|
|
HORIBA Instruments Purchases Beta Scientific Assets
|
|
|
Innovative Facilities Invited to Submit for 2009 Facility of the Year Awards
|
|
|
Inverness Medical Innovations Receives USDA Licensure of the BinaxNOW(R) Avian Influenza Virus Type A Antigen Test Kit
|
|
|
Javelin and Baxter Expand Commercial Supply Relationship for Anticipated Dyloject(TM) Global Growth
|
|
|
K-Tron Process Group Heading Up Complimentary Seminar “Innovations in Pharmaceutical Processing”
|
|
|
King Proposes Acquisition of Alpharma
|
|
|
Meda Settles U.S. Astelin Patent Litigation with Cobalt
|
|
|
Merck Selects Covance Winner Of Its Outstanding Strategic Collaboration Award
|
|
|
Multaq(R) (dronedarone) Granted FDA Priority Review for Patients with Atrial Fibrillation
|
|
|
Ortho Biotech Voluntarily Recalling One Lot Of Procrit
|
|
|
Perrigo Begins Shipments of Famotidine Complete to Customers Nationwide
|
|
|
SAFC Appoints New Vice President Of Quality And Regulatory Affairs
|
|
|
Sanofi Pasteur Shipping First Doses of Influenza Vaccine for the 2008-2009 Season
|
|
|
SuperGen Granted Orphan Drug Designation for MP-470 in Glioblastoma Multiforme
|
|
|
Swagelok Senior Research Fellow Honored By ASM International
|
|
|
UV Disinfection Specialist Aquionics Appoints New President
|
|
|
Valeant and GSK Announce Worldwide Collaboration Agreement for Retigabine
|
|
|
Wyeth’s Pearl River Facility Receives OSHA Safety Recognition
|
|
|
July 2008
A.P. Pharma Appoints Ronald J. Prentki as President, Chief Executive Officer and Member of Its Board of Directors
|
|
|
AAIPharma Receives GMP Certification From Sweden's Medical Products Agency
|
|
|
Akorn Enters into an Exclusive Contract Manufacturing Supply Agreement
|
|
|
Akorn-Strides, LLC Joint Venture Produces First Commercial Product
|
|
|
Antipodean Pharmaceuticals Announces FDA Acceptance of IND for MitoQ(R)
|
|
|
Association of Clinical Research Organizations (ACRO) Names Dr. Chair-Elect
|
|
|
AstraZeneca Submits sNDA for NEXIUM (R) I.V. for Peptic Ulcer Bleed Indication
|
|
|
Azopharma Adds of State of the Art Formulations Equipment
|
|
|
Azopharma Adds of State of the Art Formulations Equipment
|
|
|
Bavarian Nordic Reports Interim Data From Phase I/II Studies With Breast Cancer Vaccine
|
|
|
BioMarin Announces Program for ERT for Treatment of MPS IVA - Morquio A Syndrome
|
|
|
Biopure To Meet With FDA Regarding Hemopure
|
|
|
Boca Pharmacal Receives FDA Approval for Carbinoxamine Maleate 4 mg Tablet
|
|
|
Commonwealth Biotechnologies, Inc. Exercises $1 Million Put Option with Venturepharm Laboratories, Ltd.
|
|
|
Controversy About Lack of Placebo Group Decline in Alzheimer's Clinical Trials
|
|
|
Enlight Biosciences Launched in Collaboration with Merck, Pfizer, and Eli Lilly
|
|
|
Epistem Announce Collaboration With Humantics Corporation
|
|
|
European Commission Announces Marketing Authorization for 50mg Once Weekly Enbrel(R)
|
|
|
FDA Advisory Committee Unanimously Recommends Approval of Ustekinumab for Treatment of Moderate to Severe Plaque Psoriasis
|
|
|
FDA Approves Entereg to Help Restore Bowel Function Following Surgery
|
|
|
FDA Approves First Generic Divalproex Sodium to Treat Seizures, Migraine Headaches and Bipolar Disorder
|
|
|
FDA Approves First Generic Risperidone to Treat Psychiatric Conditions
|
|
|
FDA Approves GlaxoSmithKline's AVODART(R) in Combination with Tamsulosin for the Treatment of Symptomatic Enlarged Prostate
|
|
|
FDA Approves Requip(R) XL(TM), An Oral Once-Daily Non-Ergot Dopamine Agonist for Parkinson's Disease
|
|
|
FDA Grants Samaritan's HIV Drug IND Status
|
|
|
FDA Issues Not Approvable Letter for Iloperidone to Vanda Pharmaceuticals
|
|
|
FDA Launches Fellowship Program to Develop Pipeline of Scientists, Other Professionals
|
|
|
FDA Launches Fellowship Program to Develop Pipeline of Scientists, Other Professionals
|
|
|
FDA Licenses Sanofi Pasteur's New Pediatric Combination Vaccine, Pentacel(R)
|
|
|
FDA Lifts Clinical Hold on Genta's Tesetaxel, a Leading Oral Taxane
|
|
|
FDA Proposes New Rule to Provide Updated Information on the Use of Prescription Drugs and Biological Products During Pregnancy and Breast-feeding
|
|
|
FDA Requests Boxed Warnings on Fluoroquinolone Antimicrobial Drugs
|
|
|
FDA Requests Recall of Xiadafil VIP Tabs
|
|
|
FDA Rule and Companion Guidance Make Early Stage Clinical Drug Development Safe and Efficient
|
|
|
FDA Updates Label for AVANDIA(R) to Include Clinical Findings Demonstrating Sustained Glycemic Control for Up to Five Years
|
|
|
Federal Agents Seize more than $24 Million in Unapproved New Drugs
|
|
|
Feds Seize Xiadafil VIP Tablets After Company Refuses to Recall Product
|
|
|
Germany’s Schreiner MediPharm Opens Its First U.S. Facility in Blauvelt, New York
|
|
|
GlaxoSmithKline Collaborates with National Cancer Institute to Make Large Body of Cancer Cell Genomic Data Available to All Cancer Researchers
|
|
|
GSK Responds to FDA on CERVARIX® - Plans to Submit Final Study Data for Approval
|
|
|
HHS Announces New International Programs to Enhance Drug and Food Safety
|
|
|
Indevus Pharmaceuticals Provides Update on NEBIDO(R) NDA Status,
Company Expects FDA to Request Additional Safety Study Prior to Approval
|
|
|
Inimex Raises $22 Million in the Fight Against Antibiotic Resistance
|
|
|
Labopharm Receives Response from FDA Regarding its Once-Daily Tramadol Product
|
|
|
MCC Names ACRO Leaders to Board of Directors
|
|
|
NeurogesX Opens Investigational New Drug Application for Capsaicin Liquid Formulation NGX-1998
|
|
|
New AAHC Toolkit Available to Optimize Clinical Research Administration
|
|
|
New Abbott Aluvia(R) Tablet for Treatment of HIV Available in South Africa
|
|
|
Octagon Announces SDTM Data Validation Offering For Electronic Submission Data
|
|
|
Par Pharmaceutical to Launch meclizine HCL Tablets
|
|
|
Partnership Formed To Enhance Adaptive Clinical Trials
|
|
|
Pharmatech, Inc. Contracts for Five New Just-in-Time Clinical Trials
|
|
|
Ranbaxy Launches Omeprazole 40 mg Capsules
|
|
|
Rentschler Biotechnologie Extends Capacities For Mammalian Cell Culture Manufacturing
|
|
|
ResearchPoint Announces Organizational Changes
|
|
|
Sagent Pharmaceuticals Launches Ceftazidime for Injection, USP
|
|
|
Sound Pharmaceuticals Files Second IND with the FDA for the Prevention of Chemotherapy Induced Hearing Loss in Advanced Stage Cancer
|
|
|
Surefil Passes Silliker (R)Audit
|
|
|
Symyx Launches Research Services for Life Sciences
|
|
|
Taiho Pharmaceutical Selects Medidata’s Rave EDC System for Global Trials
|
|
|
Talecris Biotherapeutics Receives Orphan Drug Designation for Aerosolized Form of Alpha1-Antitrypsin (AAT) From the European Commission
|
|
|
Talecris Biotherapeutics Receives Orphan Drug Designation for Aerosolized Form of Alpha1-Antitrypsin (AAT) From the European Commission
|
|
|
TechTeam Global Forms Global Pharmaceutical Center of Excellence
|
|
|
Teva to Acquire Barr
|
|
|
The Halifax Group and SV Life Sciences Partner with Trio Clinical Research Management to Expand Unique Clinical Research Organization Model
|
|
|
TYGACIL Approved For Treatment of Patients with Community-Acquired Pneumonia
|
|
|
Viropharma Comments On Upcoming FDA Advisory Committee Meeting
|
|
|
Vitro Opens New Manufacturing Facility
|
|
|
Watson Receives FDA Approval of Potassium Chloride Extended-Release Capsules
|
|
|
Zelos Therapeutics Reaches Agreement with the FDA and EMEA for a Registration Study of ZT-031 for the Treatment of Osteoporosis
|
|
|
June 2008
Barr Announces Approval of Generic Yasmin
|
|
|
Bristol-Myers Squibb and KAI Pharmaceuticals Enter Global Alliance
|
|
|
Cambridge Major Laboratories Breaks Ground on Manufacturing Site
|
|
|
Exelixis Reaches Agreement with FDA on Special Protocol Assessment for XL184 Phase 3 Trial
|
|
|
FDA Approves ABILIFY for Add-On Treatment to Lithium or Valproate
|
|
|
FDA Approves Akorn’s Flumazenil Injection USP
|
|
|
FDA Approves Amitiza for IBS-C
|
|
|
FDA Approves Cymbalta(R) for the Management of Fibromyalgia
|
|
|
FDA Approves First Generic Ropinirole
|
|
|
FDA Grants Priority Review of Gamunex as a Treatment for Neurological Disorder CIDP
|
|
|
FDA Obtains Permanent Injunction Against Scientific Laboratories, Inc.
|
|
|
FDA Requests Boxed Warnings on Older Class of Antipsychotic Drugs
|
|
|
FDA Warns Individuals and Firms to Stop Selling Fake Cancer 'Cures'
|
|
|
FDA, European Medicines Agency to Consider Additional Test Results When Assessing New Drug Safety
|
|
|
GlaxoSmithKline and Mpex Pharmaceuticals Form Alliance to Develop Novel Efflux Pump Inhibitors for Use Against Serious Gram-Negative Infections
|
|
|
Headline Unavailable
|
|
|
Lupin Receives FDA Approval for Escitalopram Oxalate Tablets
|
|
|
Manufacturer Removes Remaining Stocks of Trasylol
|
|
|
Medimetriks Pharmaceuticals, Inc. Begins Operations
|
|
|
Mylan Launches Paroxetine Hydrochloride Extended-Release Tablets
|
|
|
Negron to Lead Pall Corp.’s Global Life Sciences Manufacturing and Supply Chain Operations
|
|
|
May 2008
Alkermes Submits sNDA For RISPERDAL
|
|
|
Confidence in FDA Hits New Low, According to WSJ.com/Harris Interactive Study
|
|
|
FDA Appoints Dr. Frank M. Torti to Senior Leadership Position
|
|
|
FDA Approves Cimzia to Treat Crohn's Disease
|
|
|
FDA Approves New Vaccine to Prevent Gastroenteritis Caused by Rotavirus
|
|
|
FDA Embarks on Major Hiring Initiative
|
|
|
Feds Seize More Than $100,000 of Unapproved Drugs Marketed as "Natural Supplements"
|
|
|
Genzyme And FDA At Odds Over Myozyme
|
|
|
Patent Litigation with Apotex
|
|
|
Perrigo Announces Approval for Over-the-Counter Children's Cetirizine Oral Solution
|
|
|
April 2008
AAPS Announces 2008 Calendar of Meetings, Conferences, and Workshops
|
|
|
Azopharma Announces Further Expansion of CTM Manufacturing Capabilities
|
|
|
Bio-Processing Industry Alliance Opens Membership To Biopharmaceutical Manufacturers
|
|
|
Cortegra Establishes New Corporate Headquarters in Parsippany, NJ
|
|
|
Elusys Therapeutics Appoints Robert Gundel as Vice President of Research
|
|
|
FDA Approves New Orphan Drug for Treatment of Rare Inflammatory Syndromes
|
|
|
FDA Approves Nexium for Use in Children Ages 1-11 Years
|
|
|
FDA Identifies First Steps in Requirements for Safety Plans for Certain Drugs and Biologics
|
|
|
FDA Issues Alert on Tussionex
|
|
|
FDA Names Permanent Director for Center for Drug Evaluation and Research
|
|
|
FDA Takes Next Step in Establishing Overseas Presence
|
|
|
FDA Warns Companies Importing and Marketing Drugs Over the Internet that Fraudulently Claim to Prevent and Treat STDs
|
|
|
ISPE and AAPS Host Life Sciences Job Fair During INTERPHEX2008
|
|
|
Keller Crescent Co. Names New CEO of Packaging Division
|
|
|
Laureate Announces Second Manufacturing Agreement With Cytheris
|
|
|
Netzsch Opens Doors to Testing Facility for Laboratory Equipment
|
|
|
Reed Exhibitions And ISPE Announce Partnership In Canada
|
|
|
Sagent Pharmaceuticals Launches Cefazolin for Injection, USP
|
|
|
Sartorius Stedim Biotech and NewAge Industries AdvantaPure Annouce Collaboration Agreement
|
|
|
Stiefel Laboratories, Inc. Appoints New President
|
|
|
Tunnell Consulting Expands Biotechnology Expertise – Appoints Dr. Siddharth To Head West Coast Office
|
|
|
Vitae Pharmaceuticals Appoints Richard Gregg, M.D. as Chief Scientific Officer
|
|
|
Wyeth to Invest $280 Million to Build State-of-the-Art Nutritional Manufacturing Facility in China
|
|
|
March 2008
2008 Facility of the Year Awards (FOYA) Winners Announced
|
|
|
Albemarle to Produce Active Ingredient of Potential New Heart Drug
|
|
|
Azopharma Product Development Group Announces Opening of a New Facility in South Florida
|
|
|
FDA Alerts Health Care Providers to Risk of Suicidal Thoughts and Behavior with Antiepileptic Medications
|
|
|
FDA Approves Asmanex® Twisthaler® For The Treatment Of Asthma In Children Ages 4-11
|
|
|
FDA Issues Public Health Advisory on Chantix
|
|
|
FDA Licenses New Hemophilia Treatment
|
|
|
FDA Releases Communication On Adverse Reactions Linked to Botox Use
|
|
|
FDA To Stop the Marketing of Unapproved Injectable Drugs Containing Colchicine
|
|
|
FDA’s 2009 Budget Advances Food and Medical Product Safety, and the Safety of FDA-Regulated Imports
|
|
|
Fette America Expands U.S. Headquarters by 25%
|
|
|
Generic Fosamax Approved
|
|
|
Genmab Agrees to Buy Minnesota Biotech Manufacturing Plant from PDL Biopharma
|
|
|
Mylan Announces Final FDA Approval for Granisetron Hydrochloride Tablets
|
|
|
Natoli And Casburt Form New Division: Natoli Europe
|
|
|
United BioSource Expands Regulatory Affairs Capabilities With The Addition Of Two Former Pfizer Execs
|
|
|
February 2008
AAPS and FDA Announce Signing of a Cooperative Research and Development Agreement
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AAPS Names Inchauteguiz Associate Executive Director
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Azopharma Product Development Group and Accu-Break Pharmaceuticals, Inc. Announce Strategic Alliance Partnership
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Carbamazepine Prescribing Information to Include Recommendation of Genetic Test for Patients with Asian Ancestry
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FDA Advisory Panel Recommends Against Approval of Merck's NDA for Non-prescription MEVACOR®
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FDA Approves Kuvan for Treatment of Phenylketonuria (PKU)
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FDA Approves New Beta Blocker to Treat High Blood Pressure
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FDA Approves New HIV Drug After Priority Review
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FDA Approves Tysabri to Treat Moderate-to-Severe Crohn's Disease
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FDA Grants Tentative Approval to First Generic for Antiretroviral Viread
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FDA Takes Action Against Compounded Menopause Hormone Therapy Drugs
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FDA's Safety Reviews of Prilosec and Nexium Find No Evidence of Increased Rates of Cardiac Events
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Idera Pharmaceuticals and Merck KGaA to Collaborate on Cancer Treatment
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Malvern Instruments Acquires Viscotek Corporation
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Millipore and Novozymes Form Alliance to Supply Animal-Free Cell Culture Supplements for Bioprocessing
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Pfizer to Acquire CovX to Extend Biotherapeutics Investment
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Precision Pharma Services Merges Into Talecris Biotherapeutics
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Saint-Gobain Finalizes Agreement to Acquire IFK Isofluor GmbH
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December 2007
ABILIFY® Approved for Adolescent Patients With Schizophrenia
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Drugs and Dietary Supplements Seized From St. Louis Company
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FDA Approves Nonprescription Zyrtec-D for Allergies, Colds
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FDA Requests Marketing Suspension of Trasylol
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FDA Requests Recall of Dietary Supplements
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FDA Says Consumers Continue to Buy Risky Drugs Online
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FDA Strengthens Boxed Warnings, Approves Other Safety Labeling Changes for Erythropoiesis-Stimulating Agents (ESAs)
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Kiadis Pharma's Lead Product Granted Orphan Drug Designation
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Premier Healthcare To Assist FDA In Evaluating Drug Risks
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Sanofi Pasteur Initiates Phase II Trial of Cell Culture-Based Seasonal Influenza Vaccine
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November 2007
Dey L.P. and Critical Therapeutics Launch Twice-Daily ZYFLO CR™ Extended-Release Tablets for the Chronic Treatment of Asthma
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FDA Announces Revisions to Labels for Cialis, Levitra and Viagra
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FDA Approves First Generic Versions of Trileptal
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FDA Approves Genzyme's Renvela™ Tablets for Dialysis Patients
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FDA Approves IXEMPRA™ For The Treatment of Advanced Breast Cancer
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FDA Approves New 300mg Loading Dose Tablet for PLAVIX®
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FDA Expands Age Range for Use of Bacterial Meningitis Vaccine
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Health Canada Approves ATRIPLA® As A Once-Daily Single Tablet Regimen for HIV
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Sanofi Pasteur Receives FDA Approval of Meningococcal Vaccine for Children
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October 2007
AHRQ and FDA to Collaborate in Largest Study Ever of Possible Heart Risks With ADHD Medications
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FDA Accepts New Drug Application for Priority Review of Investigational HIV Treatment TMC125
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FDA Appoints Coté to Head Orphan Products Development Office
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FDA Approves First Generic Versions of Coreg
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FDA Approves New Uses for Evista
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FDA Grants Orphan Drug Status to Immtech's Pafuramidine for Treatment of African Sleeping Sickness
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FDA Proposing Phase Out of CFCs in Metered-Dose Inhalers for Epinephrine
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FDA Warns Procter & Gamble about Unlawful Marketing of Product for School Children
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Meditrina Pharmaceuticals, Inc. Announces Exclusive Global Manufacturing Agreement With Pfizer CentreSource (PCS) for Femathina™
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New Data Show That GlaxoSmithKline's Rotarix® Could Be Given With Other Routine Infant Vaccines in the U.S.
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September 2007
Canadian Business Leader Purchases Assets Of Mathis Instruments And Launches C-Therm Technologies Ltd.
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Environmental Tectonics Corporation's Sterilization Systems Division Forms New Operational Group and Expands Service Offerings
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FDA Approves Novel Antiretroviral Drug
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FDA Approves Updated Warfarin (Coumadin) Prescribing Information
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GSK's Application for Rotarix® is Accepted for Review by the FDA
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Healthcare Organizations Launch Disaster Response Initiative
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Manufacturers of Some Diabetes Drugs to Strengthen Warning on Heart Failure Risk
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Millipore and Novo Nordisk Expand Agreement to Supply Biopharm Market with Recombinant Human Insulin
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Reclast® Receives FDA Approval For Treatment of Women With Postmenopausal Osteoporosis
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Sanofi pasteur First Manufacturer to Ship Doses of Influenza Vaccine for the 2007-2008 Season
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Total Solution Provider for Next Generation Biomanufacturing
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August 2007
Caraco Pharmaceutical Laboratories, Ltd. Announces Tentative FDA Approval for Generic Provigil®
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FDA Approves First Drug for Treating Fibromyalgia
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FDA Approves First Generic Versions of Lamisil Tablets
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FDA Grants Fast Track Designation to Cardium's Phase 3 Angiogenic Gene Therapy for Heart Disease
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Glatt To Host Solid Dosage Symposium
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Nabi Biopharmaceuticals Announces Creation of Pharmaceuticals Business Unit
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New Report Offers A Detailed Analysis of the Leading Players in the Indian Pharmaceutical Market
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PennTech Machinery Corporation And Shanghai Tofflon Sign Joint Venture
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Pfizer Receives Positive Opinion from CHMP for Celsentri®
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Schering-Plough Announces Licensing of Acadesine, an Investigational Agent Being Studied for Prevention of Complications From Cardiac Surgery
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July 2007
Bradley Pharmaceuticals Launches Authorized Generic of ADOXA®
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Cephalon Receives FDA Approval of NUVIGIL™ for the Treatment of Excessive Sleepiness Associated with Three Disorders
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FDA Approves New Orphan Drug for Treatment of Pulmonary Arterial Hypertension
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FDA Grants Priority Review for Bristol-Myers Squibb's Investigational Oncology Treatment Ixabepilone
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FDA Grants Priority Review for Oral Formulation of HYCAMTIN® (topotecan) to Treat Relapsed Small Cell Lung Cancer
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Kurve Technology and Schering-Plough Sign Expanded Technology Agreement
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Neurocrine Announces Resubmission of NDA for Indiplon Capsules
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Outsourcing to Biotechs Is the Answer for Many Pharma Companies' Development Woes
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Regulatory Cooperation Expanded
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Sciele Pharma Completes Acquisition of Alliant Pharmaceuticals
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June 2007
ANI Pharmaceuticals, Inc. Acquires State-of-the-Art Rx Facilities and Inks Long-Term Supply Agreement with Solvay Pharmaceuticals
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AstraZeneca to Begin Construction of $100M R&D Expansion
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Bristol-Myers Squibb Breaks Ground on new Biologics Manufacturing Facility in Massachusetts
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FDA Advises Manufacturers to Test Glycerin for Possible Contamination
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FDA Advisory Committee Finds Substantial Evidence to Support Advair 500/50 in Reducing COPD Exacerbations
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FDA Approves First Generic Versions of Ambien for Insomnia
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FDA Approves First U.S. Vaccine for Humans Against the Avian Influenza Virus H5N1
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FDA Approves Oscient Pharmaceuticals' FACTIVE® Tablets for Five-Day Treatment of Community-Acquired Pneumonia
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Major Manufacturer of Unapproved and Adulterated Drugs Agrees to Stop Illegal Practices
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New Critical Path Report Highlights Research Needed to Foster Generic Drug Development
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April 2007
FDA Approves New Drug Treatment for High Blood Pressure
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FDA Approves TYKERB® in Combination With Xeloda® for the Treatment of Advanced or Metastatic Breast Cancer
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FDA Extends Marketing Exclusivity for LEVAQUIN®
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FDA Takes Action to Halt Marketing, Manufacturing and Distribution of Illegal Drugs to Treat Migraine Headaches
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Report Says New Drugs from Novartis and Daiichi Sankyo Will Achieve Blockbuster Status in the Hypertension Drug Market
|
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Roche Files Supplemental New Drug Application for Tamiflu® 30 mg and 45 mg Capsules
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Spectrum Pharmaceuticals Reaches Special Protocol Assessment Agreement With FDA on Phase 3 Trials for EOquin®
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Sucampo Pharmaceuticals Initiates Post-Marketing Studies of AMITIZA® in Subjects with Renal or Hepatic Impairment
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Teva Receives Approval for Generic Dostinex® Tablets
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March 2007
Aptuit Completes Acquisitions of EaglePicher Pharmaceutical Services and SSCI
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Critical Path Liver Toxicity Biomarker Study to Commence with Participation from Seven Pharmaceutical Companies
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FDA Announces Label and Indication Changes for the Antibiotic Ketek
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FDA Approves Orlistat for Over-the-Counter Use
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for Post-Exposure Prophylaxis Against Anthrax Infection
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Manufacturing Facility
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Merck and Nano Terra LLC Announce New Nanotechnology Solutions Alliance
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Nortec Announces FDA Approval Of Its Generic Inderal-La Licensed To Par Pharmaceutical
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Two Baxter Facilities Recognized With Shingo Prize For Excellence In Manufacturing
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USP Publishes Standards for Medications for Neglected Diseases
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February 2007
Astellas Pharma US, Inc. Announces Availability of MYCAMINE 100mg Vial
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AstraZeneca Announces RECENTIN as Global Trademark for AZD2171
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Bristol-Myers Squibb and AstraZeneca Announce Worldwide Collaboration to Develop and Commercialize Diabetes Compounds
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Double-Digit Growth Drives Oral Drug Delivery Market to $52 Billion by 2010
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FDA Approves First Generic Ondansetron Tablets, Orally Disintegrating Tablets and Oral Solution
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FDA Approves New Drug for Schizophrenia
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FDA Proposes Labeling Changes to Over-the-Counter Pain Relievers
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Genentech Again Named One of FORTUNE's 100 Best Companies to Work For
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Genzyme Reports Strong Fourth-Quarter Revenue Growth
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MediVas and PacificGMP Announce Collaboration on Novel Therapeutic Vaccines
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January 2007
Alcan To Invest $27.5 Million In Shelbyville, Kentucky Pharmaceutical Packaging Center
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Deputy Commissioner for Medical and Scientific Affairs to Leave FDA
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FDA Approves VELCADE® for Injection for Aggressive Form of Non-Hodgkin's Lymphoma
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FDA Proposes Rules Overhaul to Expand Availability of Experimental Drugs
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FDA Warns Five Firms To Stop Compounding Topical Anesthetic Creams
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Forecast Predicts Ceftobiprole Will Achieve Sales of Nearly $500 Million by 2015 for Treating Hospital-Acquired Infections
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GlaxoSmithKline to Acquire Domantis
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Merck and Idera Sign Collaboration Agreement Incorporating Idera's Toll-like Receptor Agonists in Merck's Vaccine Programs
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Oracle Acquires TOLAS Healthcare Packaging
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Stantec’s Dave DiProspero awarded ISPE Member of the Year Award
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December 2006
Bavarian Nordic Reports Progress in New Smallpox Vaccine Program
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Bayer Outlines New Global R&D Structures; U.S. Pharma Sites and Future Headquarters
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DPT Laboratories Opens New R&D, Manufacturing And Distribution Facilities
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Eisai Inc. Breaks Ground for New Oncology Facility in Research Triangle Park
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FDA Approves New Treatment for Chronic Hepatitis B in Adults
|
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FDA Approves New, Once-a-Day COREG CR for the Treatment of Three Key Cardiovascular Conditions
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Par Pharmaceutical Announces Agreement With GSK to Settle Imitrex® Injection Patent Litigation
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Samaritan Submits IND to FDA for Novel Anti-Amyloidal Alzheimer's Drug Candidate Caprospinol
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Schering-Plough Expanding Discovery Operations in Cambridge, Mass.
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World Orthopedic Drug Market Expected to Surge Past $44 Billion by 2010
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November 2006
Cobra Signs Agreement With US Naval Medical Research Center To Evaluate Cobra’s Oral Vaccine Delivery Platform
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Combination Therapy for Lung Cancer Approved by FDA
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FDA Approves Expanded Use of Treatment for Patients
With Severe Alzheimer's Disease
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FDA Approves NEXIUM for the Treatment of Zollinger-Ellison Syndrome
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Next-Generation Contraceptive Patch Now in Development
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Office of Generic Drugs Moves to the Division File System
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PharmAthene and Medarex Announce $1 Million Congressional Appropriation for Continued Development of Anthrax Therapeutic Valortim
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Phase 3 Clinical Trial Costs Exceed $26,000 per Patient
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Sanofi Pasteur to Deliver 50 Million Doses of Influenza Vaccine to U.S. Market for 2006-2007 Season
|
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Zolinza Approved for Skin Cancer
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October 2006
Advancis Pharmaceutical On Track to File NDA for Amoxicillin PULSYS
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Eighty Percent of U.S. Adults Favor Allowing Importation of Prescription Drugs, According to Poll
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FDA Approves First Generic Ciprofloxacin Injection, USP
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FDA Approves NOXAFIL(R) Oral Suspension For Prevention Of Life-Threatening Fungal Infections In High-Risk Patients
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FDA Proposes New Rule To Automate Drug Registration And Listing
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GSK Settles Transfer Pricing Tax Dispute with IRS
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Iomai Receives FDA Clearance for Study Comparing Flu Vaccine Patch to Traditional Injectable Vaccine
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More Than 100 Million Doses of Influenza Vaccine Expected to be Available This Year
|
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Pfizer's Lyrica® Approved In Europe For Difficult-to-Treat Nerve Pain
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Plavix Approved For Use In Patients With Common Form Of Heart Attack
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September 2006
American Lung Association Collaborates With Leading Vaccine Manufacturer on New Initiative
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FDA Announces Plan to Strengthen Advisory Committee Processes
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FDA Approves First Generic Meloxicam
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FDA Approves Influenza Vaccines To Be Manufactured for Upcoming Flu Season
|
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FDA Approves Oncaspar For Newly-Diagnosed Acute Lymphoblastic Leukemia
|
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|
First Medical Director Named For Emerging And Pandemic Threat Preparedness In The Center For Biologics Evaluation And Research
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Initiation of Phase I Clinical Trial with Alzheimer's Disease Drug Product AZD-103 Given FDA Clearance
|
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|
MedImmune Begins Shipping FluMist for 2006-2007 Flu Season
|
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Proposed Legislation Aims to Stem the Flow of Counterfeit Prescription Drugs
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|
Supplemental New Drug Application for Famvir Approved By FDA
|
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|
August 2006
Abbott and AstraZeneca Announce Collaboration to Develop and Commercialize CRESTOR® and Next-Generation TriCor® (ABT-335) Fixed-Dose Combination
|
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|
FDA Announces New Initiative to Modernize the Regulation of Clinical Trials and Bioresearch Monitoring
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|
FDA Approves First Generic Sertraline
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FDA Approves Lilly's Gemzar® For Ovarian Cancer Treatment
|
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|
Javelin Pharmaceuticals Wins Phase II SBIR Grant
|
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|
New Biologic Treatment for Wet Age-Related Macular Degeneration Approved By FDA
|
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|
New HIV Treatment for Patients Who Do Not Respond to Existing Drugs Approved By FDA
|
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|
TG100-115 Cardiovascular Compound Receives Fast Track Designation
|
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|
Three-Component AIDS Drug Given Tentative FDA Approval
|
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|
Vertex and Janssen Form Collaboration to Develop and Commercialize VX-950 for Treatment of Hepatitis C
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July 2006
Azilect Approved For Treatment of Parkinson's Disease
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FDA Acts to Improve Drug Safety and Quality By Strengthening its Efforts on Unapproved Prescription Drug Products Containing Carbinoxamine
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FDA Approves Resumed Marketing of Tysabri Under a Special Distribution Program
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FDA Licenses New Vaccine for Prevention of Cervical Cancer
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|
GeoVax Launches Clinical Human Trials for its HIV/AIDS Vaccine Developed at GeoVax Inc., Emory University, NIH and the CDC
|
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Life Science Pharmaceuticals Acquires Three Clinical Stage Monoclonal Antibody Programs From the Ludwig Institute for Cancer Research
|
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|
TetraLogic Pharmaceuticals Completes $36 Million Series B Financing
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|
Teva Pharmaceuticals to Invest $6 Million in CureTech For Development of a Revolutionary Cancer Drug
|
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|
West Pharmaceutical Services Names Fran DeGrazio Vice President, Marketing and Strategic Business Development
|
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|
Zostavax Licensed by FDA to Reduce Older Americans’ Risk of Shingles
|
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|
May 2006
Acuity Pharmaceuticals Licenses Broad Spectrum Anti-Infective for Ophthalmic Use
|
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|
Cobra Biomanufacturing Signs Manufacturing Agreement with the International AIDS Vaccine Initiative and GlaxoSmithKline
|
|
|
Exforge® Accepted for Review By the FDA As a New Therapy Option for High Blood Pressure
|
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|
FDA Approves First Generic Pravastatin
|
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|
FDA Names First Director of Drug Safety Policy and Communication
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|
FDA Signs Arrangement With Sweden’s Medical Products Agency
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|
FDA to Hold Nanotechnology Public Meeting
|
|
|
NDA for Rasilez® to Treat High Blood Pressure, Accepted for Review by the FDA
|
|
|
The ALS Association Awards Research Funding for a Novel Compound Developed by Sirtris Pharmaceuticals
|
|
|
Treatment for Pompe Disease Approved by the FDA
|
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|
April 2006
AstraZeneca and University of Pennsylvania School of Medicine to Collaborate on Research
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|
Dalton Pharma Services Announces Completion Of Its GMP Oligonucleotide Manufacturing Facility
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|
Experts to Evaluate Drug and Medical Device Advertising at Conference
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|
FDA Approves Methylphenidate Patch to Treat Attention Deficit Hyperactivity Disorder in Children
|
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|
FDA Awards Contract to Assess Postmarketing Study Commitment Decision-Making Process
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|
GlaxoSmithKline Begins Testing New Technology to Protect Patients Against Counterfeit Medicine
|
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|
Lilly Announces Senior Leadership Changes
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|
Ranbaxy Acquires Romanian Pharma Company Terapia
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|
|
TAXOTERE® Receives U.S. FDA Approval For Use In Advanced Stomach Cancer
|
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|
Transpharma-Medical Announces Promising Results Of Clinical Trials With Its Hpth (1-34)-Transdermal Delivery Product For Osteoporosis Treatment
|
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|
February 2006
Accentia Biopharmaceuticals Amends and Submits Fast Track Application for SinuNase
|
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|
FDA Approves First Ever Inhaled Insulin Combination Product for Treatment of Diabetes
|
|
|
G2 Therapies and Novo Nordisk Announce Global R & D and License Agreement to Develop and Commercialize Anti-Inflammatory Therapies
|
|
|
Heckmann to Become President & CEO of Chiral Technologies Inc.
|
|
|
HHS and Institut Pasteur Partner on Pandemic Influenza Preparedness
|
|
|
Mylan Announces FDA Approval for Cyclobenzaprine Hydrochloride Tablets USP, 5 mg
|
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|
Report Demonstrates Benefits of Earlier Meetings with FDA to Make Drug Review Process More Efficient
|
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|
SCIREX Appoints Dr. Susan Shelby Executive Director, Clinical Trials Management
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|
Unigen Pharmaceuticals Hires Director of Clinical Research
|
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|
Vaccinex, Inc. Announces Antibody Collaboration with Schering AG
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|
January 2006
AstraZeneca and M. D. Anderson Cancer Center Form Umbrella Scientific Collaboration Agreements
|
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|
AstraZeneca Submits sNDA for SEROQUEL® for Bipolar Depression Treatment
|
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|
Bradley Pharmaceuticals Announces Establishment of A. Aarons, Its Authorized Generic Subsidiary
|
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|
FDA Appoints New Acting Director for National Center for Toxicological Research
|
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|
FDA Approves Tamiflu for Prevention of Influenza in Children Under Age 12
|
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|
FDA Tentatively Approves a Generic AIDS Drug in Association with the President's Emergency Plan for AIDS Relief
|
|
|
Genentech Named #1 on FORTUNE's '100 Best Companies to Work For'
|
|
|
Par Pharmaceutical Receives Final Approval to Market Generic Cefzil® for Oral Suspension
|
|
|
Pfizer Introduces Radio Frequency Identification Technology to Combat Counterfeiting, Protect Patient Health
|
|
|
Roche Steps Up Tamiflu® Distribution in U.S. Cities Reporting Increased Flu Incidence
|
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|
December 2005
Alliant Pharmaceuticals Appoints Two to Corporate Positions
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|
FDA Acts to Protect Public From Fraudulent Avian Flu Therapies
|
|
|
FDA Joins Children's Health Groups to Mark Historic Milestone For Pediatric Drugs
|
|
|
FDA Joint Advisory Committee Sets Date to Review GlaxoSmithKline Consumer Healthcare's Proposal For Orlistat 60(mg) Capsules For Over-The-Counter Use
|
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|
FDA Operation Reveals Many Drugs Promoted As "Canadian" Products Really Originate From Other Countries
|
|
|
FDA Rules Anthrax Vaccine Safe and Effective to Prevent Anthrax Regardless of Route of Exposure
|
|
|
Lev Pharmaceuticals Receives Fast Track Designation For C1-INH For Hereditary Angioedema
|
|
|
New Data Highlights TYGACIL In Vitro Activity Against Resistant Gram-Negative and Extended-Spectrum Beta-Lactamase-Producing
|
|
|
Nexavar® Approved For Treatment of Patients With Advanced Kidney Cancer
|
|
|
Tanox Submits IND Application For TNX-650 For Treatment of Hodgkin's Lymphoma
|
|
|
November 2005
Cobra Biomanufacturing PLC and Advaxis, Inc. Begin Strategic Collaboration and Long-Term Vaccine Supply Agreement For Listeria Cancer Vaccines
|
|
|
Despite Limited Diagnosed Prevalent Population, Crohn's Disease Drug Market Will Experience Steady Growth
|
|
|
Dr. Janet Woodcock Honored For Scientific Leadership
|
|
|
FDA and Industry to Collaborate On Better Ways to Predict Liver Toxicity In Human Drug Trials - Part of FDA’s Critical Path Initiative to Modernizing Drug Development
|
|
|
FDA Approves Arranon For Rare Leukemia and Lymphoma
|
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|
Feds Give Researchers OK For Safety Test of Adult Stem Cells In Patients With Heart Disease
|
|
|
Momenta Pharmaceuticals Selected to Join NASDAQ Biotechnology Index
|
|
|
Reata Drug Effective In Preventing Liver Cancer
|
|
|
Sanofi-aventis Group Announces New U.S. Headquarters Location
|
|
|
Triad Pharmaceuticals Adopts New Name of Arisaph Pharmaceuticals
|
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|
October 2005
Amarin Receives Special Protocol Assessment From FDA For Two Pivotal Phase III Clinical Trials For Miraxion In Huntington's Disease
|
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|
Aspreva and Roche Conclude Special Protocol Assessment and Reach Agreement with FDA
|
|
|
CSC Wins $35.1 Million NIAID Contract for Development of Tularemia Vaccine
|
|
|
FDA Approves REMICADE® As First and Only Biologic To Treat Ulcerative Colitis
|
|
|
Fougera Receives First Tentative Generic Approval for MetroGel®
|
|
|
Genzyme Begins Trial of Myozyme® For Patients With Late-Onset Pompe Disease
|
|
|
GlaxoSmithKline To Acquire ID Biomedical Corporation
|
|
|
GlaxoSmithKline's Havrix® Now Approved For Use in Children Aged 12 Months and Older
|
|
|
HHS Buys Vaccine and Antivirals In Preparation For a Potential Influenza Pandemic
|
|
|
MedImmune Completes Cellective Acquisition
|
|
|
New Report Says Counterfeit Drug Sales to Reach $75 Billion in 2010, Up 92% From 2005
|
|
|
Ranbaxy Receives Tentative Approval to Market Tolterodine Tartrate Tablets
|
|
|
Reed Exhibitions and Sinopharm to Launch Joint Venture
|
|
|
SGX Pharmaceuticals Receives Fast Track Designation For Troxatyl
|
|
|
Stanley B. Blaylock Appointed CEO of Medmark Inc.
|
|
|
UCB's Anti-Epileptic Keppra® Meets Primary End-Point In Monotherapy Trial
|
|
|
Vical DNA Vaccine Technology Enters Phase 2 Clinical Trial For HIV
|
|
|
VioQuest Completes Merger with Greenwich Therapeutics; Acquires Oncology Compounds
|
|
|
Watson Pharmaceuticals To Consolidate Solid Dosage Manufacturing Facilities
|
|
|
West Pharmaceutical Services Names Don McMillan President, North America Pharmaceutical Systems Division
|
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|
September 2005
Epimmune and IDM S.A. Join Forces to Become IDM Pharma, Inc.
|
|
|
FDA Announces Strengthened Risk Management Program to Enhance Safe Use of Isotretinoin (Accutane) for Treating Severe Acne
|
|
|
FDA Approves Actonel® with Calcium
|
|
|
GeoPharma Acquires Controlling Interest in Antibiotic Manufacturing Facility
|
|
|
Isis Pharmaceuticals Extends Drug Discovery Collaboration with Lilly
|
|
|
NexBio Receives a $6 Million NIH SBIR Grant for the Clinical Development of a Novel Influenza Medicine
|
|
|
Pandemic Influenza Vaccine Development Accelerated at Generex Biotechnology with Hire of Senior Scientist
|
|
|
Schering-Plough Exercises Rights to Centocor's CNTO 148 Anti-TNF Agent
|
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Targeted Genetics Announces Appointment of Roger L. Hawley, An 18- Year Pharmaceuticals Industry Veteran, to Its Board of Directors
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VistaGen Therapeutics Secures Development Support for New Drug Candidate for Huntington's Disease
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July 2005
$1.3 Million Phase II SBIR Grant Enhances Velcura Therapeutics®, Inc.'s Research to Find New Drugs for People with Osteoporosis
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Aptuit to Acquire Quintiles’ Pharmaceutical Sciences, Preclinical Services and Clinical Trial Supplies
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Clive V. Bennett Appointed President, Patheon U.S.A. and President and Chief Operating Officer of MOVA Pharmaceutical Corporation
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Crawford Confirmed by Senate to Lead FDA
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FDA Issues Public Health Advisory on the Fentanyl Patch
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GlaxoSmithKline Exercises Option to LymphoStat-B
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GSA/FDA Dedicate Center for Drug Evaluation and Research (CDER) Office Building I in White Oak, Maryland
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HHS/FDA Tentatively Approves Another First-Time Generic AIDS Drug Associated with the President’s Emergency Plan for AIDS Relief
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Millipore Acquires European Contract Testing Lab
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Millipore to Acquire NovAseptic AB; Broaden Offering to Biotech and Pharmaceutical Companies
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OnSource Corporation Changes Name to Ceragenix Pharmaceuticals
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Preliminary Phase I/II Study Showed Lucentis Improved Vision in Patients With Wet Age-Related Macular Degeneration When Used in Combination With Visudyne®
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Schering-Plough Expands Its Presence in Asia Pacific; Commercial Operations Opened in Korea and Pakistan
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SCIREX Appoints Robert R. Allen, M.D., as Executive Officer, Science and Medicine
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June 2005
Actavis To Acquire US Generics Company Amide
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Alpharma Announces Agreement with Indian Firm Shasun to Develop and Manufacture Generic Prescription and API Products
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BioCryst Receives FDA Fast Track Status for Fodosine in the Treatment of Relapsed or Refractory T-cell Leukemia
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BioMarin Announces FDA Approval for Naglazyme
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Cardiovascular Drug Market to Top $100 Billion by 2008
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Eisai Inc. Announces Appointment of Vice President of Production Operations
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Epilepsy Foundation Says FDA Pregabalin Approval a Much Anticipated And Welcome Development
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FDA Licenses sanofi pasteur's ADACEL Vaccine for Combined Protection Against Tetanus, Diphtheria and Pertussis
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FDA to Use Ingenuity Pathways Analysis in Review of Pharmacogenomics Submissions
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First Tuberculosis Drug Developed by a Non-Profit Begins Clinical Trials
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Interpharma, Quintiles and Temasek to Form Pharma Commercialization Joint Venture in Asia Pacific With US $112 Million Investment Fund
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INTERPHEX Puerto Rico Call For Presentations
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Medarex and Boehringer Ingelheim Announce Antibody Development Agreement
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Mylan Laboratories Receives Approvable Letter For Its Next Generation Beta-Blocker Nebivolol
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OSG Norwich Pharmaceuticals Names New President
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Peregrine Pharmaceuticals Receives FDA Clearance to Initiate Tarvacin Anti-Viral Clinical Trial
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Pfizer Global Manufacturing Names Pete Stevenson Vice President For Contract Manufacturing/Procurement/Pfizer Centresource
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Pfizer to Acquire Vicuron Pharmaceuticals to Extend its Research Commitment in Anti-Infectives
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Pharmaceutical Profiles’ Wilding To Receive Award From Controlled Release Society
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Spectrum Authorized by FDA to Conduct Phase I/II Clinical Trial in the U.S. With SPI-153 in Hormone Dependent Prostate Cancer
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May 2005
American Urological Association Honors Novartis Pharmaceuticals With Annual Health Science Award
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AmerisourceBergen Promotes Michael D. Dicandilo To Executive Vice President And Chief Financial Officer
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Bayer and Onyx Initiate Phase III Metastatic Melanoma Trial Studying Sorafenib (BAY 43-9006) in Combination With Two Chemotherapeutic Agents
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FDA Grants SGX Orphan Drug Designation for Troxatyl SGX to Present Troxatyl Clinical Data at ASCO
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Genta and Aventis Terminate Genasense® Agreements
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HHS Awards BioShield Contract for AVA Anthrax Vaccine
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Icoria Names Doug Morton Interim CEO, Makes Management Changes to Focus on Healthcare
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Merrimack Pharmaceuticals Appoints Gary L. Crocker as Chairman of the Board
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Novartis Files Exjade New Drug Applications for Treatment of Chronic Iron Overload Due to Blood Transfusions
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Smith & Nephew Receives US FDA Clearance for ACTICOAT Moisture Control
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Southern Research Institute Announces Joint Drug Discovery Program With Schering-Plough to Seek Novel Drug Compounds
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Tm Bioscience Receives FDA Clearance For Cystic Fibrosis DNA Test
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Vaccine to Treat Nicotine Addiction Achieves Proof of Efficacy in Phase II Clinical Trial
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Vitex Announces Management Change
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April 2005
(Zolpidem Tartrate Extended Release) CIV for the Treatment of Insomnia
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Anthera Pharmaceuticals Launches With a Proven Leadership Team and Significant Series A Funding
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Arakis and Vectura Announce Agreement on New Therapy for Respiratory Disease
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Data in Clinical Cancer Research Article Shows that Peregrine's Lead VEA Compound Enhances Efficacy of Multiple Chemotherapeutic Agents
|
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Dr. Darrell Abernethy Elected President of the USP Convention
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FDA Approves New FOSAMAX PLUS To Reduce The Risk Of Both Hip And Spine Fractures
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Global Pharmaceutical Services Organization and eClinical Software Provider Partner to Improve the Late-Phase Clinical Trial Process
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Guilford Pharmaceuticals Restarts AQUAVAN®, Clinical Development Program
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ImmuneRegen BioSciences Appoints Dr. Paul Carlton to Bioterrorism
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Jeffrey W. Henderson to Become Cardinal Health CFO
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Kaferle Named Director of Projects for Somerset Office
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MedImmune Begins Dosing in Phase 1 Clinical Trial for Nasally Delivered Vaccine Designed to Help Prevent Common Childhood Respiratory Viral Diseases
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Multiple Second-Generation Antisense Drugs Effectively Inhibit Tumor Growth and Show Potential as New Anti-Cancer Drugs
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Par Pharmaceutical Receives Approval to Market Generic Ultracet®
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Peter F. Drake Joins Penwest Board Of Directors And Jere E. Goyan To Retire
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Pharmos Corporation Strengthens Management Team to Support Pipeline Development
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Prana Biotechnology Cancels Plans for PLACQUE Clinical Study
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Protein Design Labs Reports Positive Results in Phase II Clinical Trial (SIRIUS II) of Ularitide for Decompensated Congestive Heart Failure
|
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Roche Files Supplemental New Drug Application to Extend Prophylaxis Indication for Tamiflu to Patients Between One to 12 Years of Age
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Study Shows Common Painkillers Combined With Acid-Reducing Drugs More Cost-Effective, Safer for Managing Arthritis in High-Risk Patients
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Target Announces That All Products Containing Pseudoephedrine Will Be Placed Behind Pharmacy Counter
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Tarvacin Equivalent (3G4) Plus Radiation Reduces Lung Tumor Growth By Over 95%
|
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Therapy During Primary Total Hip Replacement Surgery
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TOPIGEN Appoints Biopharmaceutical Industry Executives
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USP to Publish Spanish Translation of USP – NF
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March 2005
Amarin Corporation Announces Additional Positive Clinical Data for Miraxion™ To Treat Unresponsive Depression
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Antares Pharma Files IND for Its First Proprietary Pharmaceutical Product - Transdermal Gel to Treat Overactive Bladder Syndrome
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|
BioCryst Pharmaceuticals Successfully Completes Phase I Trial With Oral BCX-4208 for Psoriasis
|
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|
Dow Stake Positions DNT and Starpharma as Leading Developers of Nanotechnologies for the Pharmaceutical, Biotechnology Industries
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|
Drug Information Association Names New Executive Director
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FDA Accepts ACEON Supplemental New Drug Application for Filing
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FDA Announces Dates for Public Meeting on Non-Steroidal Anti-Inflammatory Drugs
|
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|
FDA Approves First Gene-Based Test, UroVysion™ for Diagnosis of Patients Suspected of Having Bladder Cancer
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FDA Clears the Way for Generic Versions of Transdermal Patches to Treat Chronic Pain
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|
FDA Rejects Public Citizen's Petition for AstraZeneca's CRESTOR®
|
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|
Interim Analysis of Phase III Trial Shows Avastin Plus Chemotherapy Extends Survival of Patients With First-Line Non-Squamous, Non-Small Cell Lung Cancer
|
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|
La Jolla Pharmaceutical Announces Outcome of Recent FDA Discussions
|
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New Chromium Supplementation Clinical Trial Initiated - First to Study Effects in Overweight Children with Type 1 Diabetes
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|
Partnership With Pfizer
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|
|
QuatRx Pharmaceuticals Licenses Novel Lipid-Lowering Drug
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Reforms Will Improve Oversight and Openness at FDA
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|
Spectrum Pharmaceuticals Announces the Hiring of Dr. Rudi E. Moerck as Consultant
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USP Receives ISO 17025 Accreditation for Compliance in Science Laboratories
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USP to Establish Site in India
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USP to Publish Spanish Translation of USP – NF
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February 2005
‘Multivac University’ Announces 2005 Schedule
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|
Clinical Trials May Face Patient Shortfalls in 2005
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|
Conference Theme: Doing More With Less Through Technology
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|
Cornerstone BioPharma and Adams Laboratories Enter Agreement
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|
|
FDA Accepts ACEON Supplemental New Drug Application for Filing
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|
FDA Clears Generic Versions of Transdermal Patches
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|
FDA Clears the Way for Generic Versions of Transdermal Patches to Treat Chronic Pain
|
|
|
FDA Grants Priority Review to Keppra for Use in Childhood Epilepsy
|
|
|
FDA Issues Nationwide Alert on Syringes
|
|
|
Forest Laboratories, Inc. Announces Launch of Clinical Trial Registry
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|
|
Halozyme Therapeutics Signs Commercial Manufacturing Agreement
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|
|
Lilly Announces Individual Bar Coding on All Insulin Vials
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|
|
New Chromium Supplementation Clinical Trial Initiated
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|
|
Pyro Pharmaceuticals to Receive Patent
|
|
|
Reforms Will Improve Oversight and Openness at FDA
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|
|
TOPIGEN Initiates Phase I Study of ASM8, its Inhaled Asthma Product
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|
|
USP to Establish Site in India
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|
|
Viragen Reports Advancement in Avian Transgenics Biomanufacturing
|
|
|
West Pharmaceutical Services, Inc. Appoints Director of Regulatory Affairs
|
|
|
January 2005
Alliance Formed to Develop Anti-Anthrax Antibody
|
|
|
American Filtration & Separations Society Makes Strategic
|
|
|
Amphora Discovery Announces Inflammatory Disease Collaboration
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|
|
Callisto Pharmaceuticals Appoints Vice President, Regulatory Affairs
|
|
|
Colowick Named Chief Medical Officer at Threshold Pharmaceuticals
|
|
|
DOR BioPharma And Cambrex Enter Into A Process Agreement
|
|
|
Dow Stake Positions DNT and Starpharma as Leading Developers
|
|
|
DPT Laboratories And Bradley Pharmaceuticals Solidify Partnership
|
|
|
FDA Announces Dates for Public Meeting on Inflammatory Drugs
|
|
|
FDA Approves First Gene-Based Test
|
|
|
Greer Receives FDA Approval To Begin Sublingual-Oral Immunotherapy Trial
|
|
|
Inpharmatica - Announces PharmaCarta Partnership With Pfizer
|
|
|
Omron Donates Nearly $1 Million To Asian Tsunami Relief
|
|
|
Patheon Announces Completion Of MOVA Pharmaceutical Acquisition
|
|
|
PharmaDiscovery 2005 Conference To Feature Leading Scientists
|
|
|
STL Affiliate Receives DEA Registration - Broadens Range of Capabilities
|
|
|
Susan de Mars Joins USP
|
|
|
USP Establishes Collaborative Research Agreement With Health Canada
|
|
|
USP Proposes Constitution And Bylaws Changes
|
|
|
USP Receives ISO 17025 Accreditation for Compliance in Science
|
|
|
December 2004
Antibiotic Warning Labels Toughened by FDA
|
|
|
Bristol-Myers Squibb Offers Update on Muraglitazar and Abatacept
|
|
|
Bristol-Myers Squibb to Sell Oncology Therapeutics Network
|
|
|
FDA Accuses Company of Illegal Importation
|
|
|
FDA Approves Drug for Use in Cataract Surgery
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|
|
FDA Warns Consumers About Carbolith 150 mg Capsules From Canada
|
|
|
GlaxoSmithKline to Bring 4 Million Flu Vaccines to U.S.
|
|
|
Innovative Drug Delivery Systems and Intrac Complete Merger
|
|
|
Kelso & Co. Ups Stake in DLI Holding
|
|
|
LabCorp In Definitive Agreement to Acquire US Pathology Labs
|
|
|
Medical Device Event Slated For Puerto Rico
|
|
|
Memory Pharmaceuticals CFO Resigns
|
|
|
Pfizer and ChondroGene in New Osteoarthritis Collaboration
|
|
|
Ranbaxy’s Fluoxetine 40mg Capsules Are Approved By FDA
|
|
|
Wyatt Technology Completes Acquisition
|
|
|
November 2004
‘Independent’ Drug Safety Office Seen As Goal of Senate Vioxx Investigation
|
|
|
Affimed Therapeutics and Syngenta Unit Agree to Codevelop Tandabs
|
|
|
Artemis and Schering To Cooperate
|
|
|
Bristol-Myers Squibb Foundation Targets Hepatitis B in China
|
|
|
DuPont Names de Andrade to Biotechnology Advisory Panel
|
|
|
Emerson and GE Collaborate on Protein Purification Systems
|
|
|
FDA Announces Initiatives For Dietary Supplements
|
|
|
FDA Approves New Drug For the Most Common Type of Lung Cancer
|
|
|
FDA Backs Use of RFID Technology to Protect the US Drug Supply
|
|
|
FDA Completes Review of Reprocessed Single Use Devices
|
|
|
FDA Enhances Accutane Risk Management
|
|
|
FDA Files Complaint Over Sale of Ephedra
|
|
|
FDA Issues Warning on Two Sexual Enhancement ‘Dietary Supplements’
|
|
|
FDA Names Dr. Edward Otto to Head Cellular, Tissue & Gene...
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|
|
FDA Reorganization Plan Would Eliminate Split Neuropharm Division
|
|
|
Former Pharmaceutical Executive Sentenced in Drug Counterfeiting Case
|
|
|
Foster Wheeler’s John Nichols Elected to the ISPE Board
|
|
|
GlaxoSmithKline Awards $250K in HIV/AIDS Research Grants
|
|
|
GlaxoSmithKline Markets New Nicotine Gum
|
|
|
Monoclonal Antibody Treatment For MS Approved
|
|
|
New Drug Allows Smokers to Quit Without Adding Pounds
|
|
|
New Surgical Marker Using RFID Cleared By FDA
|
|
|
Pfizer Pays Final $1M to ChondroGene
|
|
|
Pfizer Terms Canadian News Report Questioning Celebrex Safety
|
|
|
Terrorism Fears Spur Production of Mobile Command Centers
|
|
|
October 2004
Abbott Acquires Spine Next, S.A., a Maker of Non-Fusion Spinal Implant
|
|
|
Apologies to NYC, But Detroit Is the City That Really Doesn’t Sleep
|
|
|
Assured Automation to Distribute Memry Corp.’s ‘Firechek’ Valves
|
|
|
Bristol-Myers Squibb Submits Applications to Market Entecavir
|
|
|
Cellular Genomics Appoints Klein to New Drug Development Post
|
|
|
ChemBridge Corp. and University of Hong Kong In Possible...
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|
|
Codexis Names New Director of Business Development For Europe
|
|
|
Consultancy Urges More Emphasis on Downstream Biopharm Processing
|
|
|
FDA Finds Hillestad Pharmaceuticals in Violation of Permanent Injunction
|
|
|
FDA Issues Final Report on Its Regulation of Pharmaceutical
|
|
|
FDA Revises Antidepressant Product Labeling
|
|
|
FDA Says All of Chiron’s Liverpool Flu Vaccine Output Is Unsafe
|
|
|
Health Services Workers Suffer From Excessive Workloads and Stress
|
|
|
Honeywell to Acquire Aspen’s Operator Training Business
|
|
|
Merck Takes Vioxx Off the Market
|
|
|
Nastech and Par Enter into Agreement for Nasal Calcitonin
|
|
|
Report: $2.6 trillion in products will incorporate emerging nanotechnology
|
|
|
Research Results May Aid in Treatment of Rheumatoid Arthritis
|
|
|
Sanofi-Aventis Plans $1 Billion Generic Business To Support Managed Care
|
|
|
Study: Eli Lilly Drug To Shift Focus From Pain Control to Disease
|
|
|
September 2004
Aeolus Application for ALS Treatment Allowed by FDA
|
|
|
Antares Pharma Approved For Listing on the American Stock Exchange
|
|
|
Callisto Pharmaceuticals Appoints Dr. Roman Perez-Soler
|
|
|
Europe Okays Gliadel to Treat Newly Diagnosed Patients
|
|
|
FDA Supports Recommendations on Use of Antidepressants For Children
|
|
|
Foster Wheeler Secures Repeat Business with Merck, Sharp & Dohme
|
|
|
MAP Pharmaceuticals Closes $30 Million Stock Financing
|
|
|
McGarty Named Chief Executive Officer of Fougera
|
|
|
Melissa Herkt Joins Emerson Process Management As President
|
|
|
NABP and BuzzeoPDMA Take on Prescription Drug Counterfeiting
|
|
|
New Unit Aims to Improve Pet Medications
|
|
|
NovaDel Pharma Licenses Nitroglycerin Lingual Spray
|
|
|
Paul B. McGarty Named As Chief Executive Officer Of Fougera
|
|
|
Pfizer and Eyetech Joint Filing Accepted in EU; Action Pending Elsewhere
|
|
|
Podlesak Named President and CEO at Peninsula
|
|
|
Poll: Most Americans Favor Price Controls to Rein In Health Care Costs
|
|
|
Sierra Instruments Launches Operations in Guangzhou, China
|
|
|
Subsequent Offering Period For Aventis Expires
|
|
|
Thermo Electron Acquires InnaPhase Corp.
|
|
|
USP Annual Scientific Meeting Scheduled in New Jersey
|
|
|
Walcoff Appointed to FDA Post
|
|
|
West Pharmaceutical Services Announces Official Opening
|
|
|
August 2004
Agile Therapeutics Closes $4.5 Million Financing
|
|
|
Astralis Announces Resignation of CEO and CFO
|
|
|
ChiRhoClin Announces the Launch of Human Secretin for Injection
|
|
|
Computer Sciences Acquires Full Interest in DynPort Vaccine Co.
|
|
|
ConvaTec To Introduce Redesigned Skin Care Packaging
|
|
|
Dyslipidemia Drug-Treated Population to Grow 4% Annually,
|
|
|
EDA, Quaker BioVentures Will Partner in New Venture Fund
|
|
|
Enanta Pharmaceuticals Raises $20 Million in New Financing and Initiates
|
|
|
ESC Touted As New Alternative to RFID in Drug Packaging
|
|
|
GeoPharma Acquired Rights to Market ANDA Drug Prednisone
|
|
|
Lexicon and Takeda Collaborate to Develop Drugs for High Blood Pressure
|
|
|
Mylan Withdraws Lawsuit in Order to Consider Additional
|
|
|
Non-profit Medical Newsletter Examines Performance-Enhancing Drugs
|
|
|
Pharma Thought Leaders: Companies Average 46 MSLs
|
|
|
Pharming Acquires Patent Portfolio of PPL Therapeutics
|
|
|
Phoenix Contact Inc. Acquires Entivity
|
|
|
Publication Reports Boniva Significantly Reduced Vertebral Fractures
|
|
|
Ranbaxy Receives FDA Approval for Loratadine Syrup
|
|
|
Report: Pharma Research Budgets Jump 73% From Phase II to III
|
|
|
Roche and Memory Pharmaceuticals Extend Research Collaboration
|
|
|
Sirna and Archemix Form Aptamer Manufacturing Alliance
|
|
|
Thermo Electron Enters New Lab Automation Partnership with Novartis
|
|
|
Transition Therapeutics Licenses Diabetes Regenerative Therapy
|
|
|
Viragen Granted U.S. Patent for Manufacture of Multiferon
|
|
|
Wireless Breakthrough for Home Health Monitoring Announced
|
|
|
July 2004
Barr Submits Response to FDA in Support of Over-the-Counter Status
|
|
|
Chiron Delivers First Million Doses of Fluvirin Influenza Vaccine to U.S.
|
|
|
Congressman Greenwood Named Next BIO President
|
|
|
Dr. Vladimir Vapnik Named to Health Discovery Corporation Board
|
|
|
FDA Approves New Labeling for AstraZeneca's SEROQUEL
|
|
|
FDA to Review Drug for Breast Cancer in Postmenopausal Women
|
|
|
Inverness Medical Innovations Ships First Digital Ovulation Test
|
|
|
King Pharmaceuticals Announces Brian A. Markison as President and CEO
|
|
|
Late-Stage Marketing Budgets on the Rise, Study Shows
|
|
|
New Treatment Guidelines Cite Drug for PCI in Acute Heart Attack Patients
|
|
|
Osteoporosis Web Site Offers Consumers Holistic Approach
|
|
|
Par Pharmaceutical Submits NDA for Megestrol Acetate Oral Suspension
|
|
|
Pfizer to buy rights to Campto from Aventis
|
|
|
Velcura Therapeutics Announces DNA Microarray to Help Bone Disease
|
|
|
June 2004
AMA Passes New Policies to Help Fight Obesity
|
|
|
American Pharmaceutical Partners Receives FDA Approval
|
|
|
Bradley Pharmaceuticals to Acquire Bioglan
|
|
|
Cancer Drug Featured at Scientific Meeting
|
|
|
DHHS Recommended to Establish Registry For U.S. Clinical Trials
|
|
|
DuPont to Acquire Maxygen Subsidiary
|
|
|
Endocrine Society Hears Early Patient Response for Forteo
|
|
|
Fitness Group Wants Congress to Support Obesity Solutions
|
|
|
ICOS and Raven Biotechnologies Collaborate for Antibody Therpeutics
|
|
|
James D. Crapo Named CEO of Incara
|
|
|
Panacos Pharmaceuticals to Merge With V.I. Technologies
|
|
|
Peninsula Pharmaceuticals Testing Drug for Hospital-Acquired Pneumonia
|
|
|
Pennsylvania Attorney General announces...
|
|
|
Pfizer strives to serve communities in need
|
|
|
Prices of drugs for seniors rose dramatically in 2003, report says
|
|
|
Schering to consolidate New Jersey operations
|
|
|
Schering-Plough Names Hans M. Vemer Senior Vice President
|
|
|
Schering-Poulgh Reaches Agreement with U.S. Securities
|
|
|
Scientists to Present Progress on Vaccines
|
|
|
Serono receives FDA approval for infertility drug
|
|
|
Solutia enters anti-cancer drug conjugates field
|
|
|
Watson Pharmaceuticals Announces Launch of Acute Pain Product
|
|
|
May 2004
AARP Unit Warns Against Drug Discount Card Scams
|
|
|
Adams Respiratory Leaves Texas for NJ; Two Appointments Announced
|
|
|
Bristol-Myers Squibb and Solvay Agree to Develop Obesity Compound
|
|
|
CDC Issues New Pediatric Influenza Immunization Recommendations
|
|
|
Cialis, Levitra Score Big in the Minds of Viewers
|
|
|
Cordis Announces Nationwide Recall of Revised Stent Instructions
|
|
|
FDA Approves Colonoscopy Prescription Preparation
|
|
|
FDA Approves Mucinex DM Tablets for Over-the-Counter Sales
|
|
|
Honeywell Receives Pharmaceutical Automation Award
|
|
|
Louisiana Enacts Prescription Privileges Law for Psychologists
|
|
|
Martek Chief to Present at the Smith Barney Citigroup Conference
|
|
|
Neubauer Named President and COO of Health Enhancement Products
|
|
|
New Cancer Drug Gets FDA Approval
|
|
|
Novo Nordisk Reports First Quarter Results
|
|
|
Nutraceutical Completes Its Acquisition of Natural Balance
|
|
|
Pfizer Partnership in Uganda Showing Results vs. HIV/AIDS
|
|
|
Roche Funds New Anemia Research Foundation
|
|
|
Thermo Electron Acquires US Counseling Services
|
|
|
Top King Pharmaceuticals Executive Resigns
|
|
|
Valeant Pharmaceuticals to Sell Kinerase products in Europe
|
|
|
April 2004
‘CSI’ Star to Pay Tribute to Lab Professionals
|
|
|
Abbott Lab Reviews 2003 Accomplishments at Shareholders' Meeting
|
|
|
Abbott Labs to Hold Conference Call on First-Quarter Earnings
|
|
|
Aventis Gains FDA Approval for Apidra
|
|
|
Bradley Pharmaceuticals Forms Podiatry Advisory Board
|
|
|
Caraco Pharmaceutical Receives FDA Approval for Mirtazapine
|
|
|
Discovery Partners In Collaboration Deal With Vertex Pharmaceuticals
|
|
|
Incara Pharmaceuticals Closes on $10+ Million Financing
|
|
|
Johnson & Johnson to Offer Medicines Free to Some Medicare Beneficiaries
|
|
|
JRS Pharma’s Prosolv Now Ready For Use in Japan
|
|
|
LAM Signs Distribution Deal with China's Largest Pharmaceutical Firm
|
|
|
Moses Named to New Medical Affairs Post At Novo Nordisk
|
|
|
Pfizer Completes Sale of In-Vitro Allergy Diagnostic Testing Business
|
|
|
Pfizer Reacts to Inclusion in Dow Jones Industrial Average
|
|
|
Pharmacy Care Alliance Network Extends to More Than 41,000 Pharmacies
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Philadelphia Conference to Focus on Recent FDA Announcements
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Sanofi Merger With Aventis to Create No. 3 Drugmaker
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USDA Approves Prionics ‘Mad Cow’ Tests
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Warrick Pharmaceuticals Launches Generic Ribavirin Product
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Wyeth, Solvay to Co-Develop Product Candidates and Co-Promote
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March 2004
Abbott Labs Honors Employees For Exceptional Performance
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Atrix to Distribute Dermatology Products in Canada
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Biotech Holdings Sucanon drug facility nears completion
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CEI Opens New Cleanroom Manufacturing Facility In Syracuse
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Centocor to Acquire Wyeth Facility in St. Louis
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Chiron to Discontinue Development of Tezacitabine
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FDA Accepts SuperGen's New Drug Application for Filing
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IMC expands lineup to include smart RFID closure
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ISTA CEO to Speak at Biotech Industry Conference
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James C. Mullen Elected to PerkinElmer Board
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Logica Executive Chosen to Head Up Alltracel Alliance
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Medical Services in Joint Venture For Chinese Production Facility
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Millipore and HyClone Align to Optimize Biopharmaceutical Drug Production
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Millipore Appoints Vice President of Worldwide Manufacturing Operations
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MonoSol LLC and Kosmos Pharma Form MonoSolRX LLC to Commercialize Oral Film Strip Pharmaceutical Products
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MRO Software and Stelex Announce Alliance to Help Manage Risk, Reduce Validation Costs for Customers in FDA Regulated Industries
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PA Attorney General Sues 13 Major Drug Companies
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Peregrine Publishes Article on Tumor Necrosis Therapy Technology
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Pharmacy Alliance Gets Medicare Endorsement for Prescription Card
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Roche Picks Genmab Antibodies For Clinical Development
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Schering-Plough and Merck Cholesterol Tablet Approved in Mexico
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Vaccine Maker Develops Application Using InBatch
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February 2004
FDA Reports 9% Increase In NDA Filings In 2003
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FTC Notification Requirement For Patent Settlements Now In Effect
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IBM and FAST to jointly sell and market e-business solution to the life sciences market
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Organizations Address Drug Distribution Quality Control Problems
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Pilgrim And Stelex To Help Life Science Companies Achieve Operational Excellence
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Sparta Systems and Open Text Partner to Provide Solutions for Quality Management and Electronic Document Management
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USP 27- NF 22 Becomes Official - Third Annual Edition Contains New Requirements
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What you need to know today
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January 2004
BioPoint Solutions, Inc. Established to Deliver Pre-Clinical Data Management and Workflow Enforcement for the Biotech and Pharmaceutical Marketplace
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DFB Pharmaceuticals Acquires Phyton Inc., - World's Largest Plant Cell Fermentation Facility
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Honeywell To Implement System at Boehringer Ingelheim Plant
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Taste Technology Company Receives Funding For Further Research To Eliminate Bitter Taste In Oral Medicines
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November 2003
Bayer and ComGenex Extend Drug Discovery Collaboration
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FDA’s PAT initiative promises significant benefits in process efficiency, cost control and product quality
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New Patent Covers Many Cancer Treatments
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Thermo Electron Acquires Laboratory Services Provider LMSi
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West Pharmaceuticals, Inc Appoints New Vice President of Business Development for Drug Delivery Division
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October 2003
Klöckner Pentaplast Acquires Greenway Plastics Industries
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USP Appoints New Director of Non-Complex Actives and Excipients
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September 2003
Chase-Walton Promotes Tim Pryce to President
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August 2003
Alfa Laval and Millipore Sign Joint USA Marketing Agreement
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Anderson Instrument Co. Acquires Accurate Metering Systems, Inc.
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West Pharmaceutical Services, Inc. Appoints New Chief Financial Officer
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West Pharmaceutical Services, Inc. Creates New Position To Strengthen Compliance Activities -
Linda R. Altemus Appointed Vice President & Chief Compliance Officer
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July 2003
Aventis Commits To Honeywell POMS MES 5.1 And Migration Services For Largest North American Operation
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Chemir Acquires Lycoming Analytical Laboratories, Creates New Division:
Chemir Pharma Services
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Pepperl+Fuchs Acquires Bebco EPS
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PPD Restructures Discovery Sciences to Better Align with Market Drivers
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Revision Proposed to USP General Chapter <1> Injections
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The Elizabeth Companies Appoint Logic TPS, Ltd as Their Exclusive Representative for Their Tooling Product Lines in the United Kingdom and Ireland
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USP Examines Safety Issues Related to the Distribution of Drug Products
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May 2003
FlexLink Introduces All-Stainless Pharmaceutical Packaging Solution
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April 2003
IntraLinks Names Thomas Engel Vice President of Strategic Business Development for Life Sciences Industry
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Latest Dust Explosion Kills Four, Hospitalizes Nine
in Pharmaceutical Plant Disaster
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Program for Operational Excellence In Regulatory Compliance
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USP Names New Leader For Research & Development Laboratory
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March 2003
ITT Industries Acquires BioPharm Manufacturing Division of Martin Peterson Company, Inc.
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Roche Molecular Diagnostics selects Johnson Controls for $4.6 Million Technology, Validation Services Contract
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USFILTER Introduces The New PREVUE(tm) System At INTERPHEX'03
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February 2003
Entegris Inc. Acquires Electrol Specialties Company
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USP's Pharmacopeial Forum (PF) Is Now Available Online
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January 2003
Cambridge Major Laboratories Acquires Former Oread Pilot Plant Assets
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