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Industry News
 
April 2009

X-Ray Inspection System Designed For Quality Control In A HACCP Plan
 
February 2009

Amylin Shares Rise As Icahn Raises Stake

Bayer Schering Pharma To Open Beijing R&D Center

Biogen Idec 4Q Profit Grew 3 %

Bristol-Myers Stock Jumps On Takeover Speculation

Cephalon Linked To Indicted Kansas Doctor

Debate On North Dakota Pharmacy Bill Takes On Edge

Dr. D. Gary Gilliland, Internationally-Recognized Physician and Researcher, Joins Merck Research Labs as Head of Oncology Research

Drug Maker Sentenced For Illegal Imports

FDA Approves Clinical Studies Of A Novel Anti-Cancer Drug Developed By Italian Researchers

FDA Approves KAPIDEX Delayed Release Capsules For The Treatment Of GERD

FDA Approves ULORIC(R) (febuxostat) for the Chronic Management of Hyperuricemia in Patients With Gout

FDA Delays Decision On J&J Drug For Mood Disorder

FDA Extends Review Time For Gout Drug

FDA Probes Lilly Blood-Poisoning Treatment

FDA Reviewing Lilly’s Blood Thinner Prasurgel

FDA Seeks Plans To Reduce Misuse Of Painkillers

Federal Trade Commission Files Complaint Against Par Pharmaceutical Over Court-Approved AndroGel(R) Litigation Settlement

Galderma Wins FDA Approval for Vectical Ointment, a Novel Topical Therapy for Psoriasis

Germany's Merck Reports 4Q Loss Of euro279.5 Million

GlaxoSmithKline 4Q Profit Falls, Confirms Job Cuts

GTx's Bone Fracture Drug Under FDA Review

Headline Unavailable

Huge Study Boosts Disappointment On Multivitamins

Human Genome Sciences Begins Delivery of First-in-Class Anthrax Treatment to U.S. Strategic National Stockpile

Ireland's Elan Trims Losses As MS Drug Sales Surge

J&J Seeks Full FDA Approval For HIV Treatment

KV Pharmaceutical Company Reduces Workforce

La Jolla And BioMarin Stop Riquent Trial

MDRNA, Inc. Announces Licensing Agreement With Roche

Merck Will Buy Insmed Biosimilars For $130 million

Novartis May Pay More Than $575M For Blood Thinner

Novogen To Focus On Oncology Program

Official: Sebelius Near Top For Health Post

Oregon Attorney General: Bayer Settling Ad Case For $20 Million

Pfizer Cancer Drug Gets Nod In UK Recommendation

Pfizer Discontinues Global Phase III Trial of Axitinib for Futility in Advanced Pancreatic Cancer

Pfizer To Disclose Payments To Doctors Next Year

Prasugrel Receives Unanimous Approval Recommendation From FDA Advisory Committee

Report: Extavia's Launch Foreshadows Novartis' Future Intentions in the Multiple Sclerosis Market

Report: Glaxo To Cut Prices For Poor Countries

Reports: GlaxoSmithKline To Cut Thousands Of Jobs

Roche CEO: Offer For Genentech A Fair Deal

Roche Launches $86.50-A-Share Bid For Genentech

Roche Says Full-Year Net Income Down 5 Percent

Sandoz Accused By Alabama Of Overpricing

Sanofi Pasteur Dengue Vaccine Enters Pediatric Efficacy Clinical Study

Sanofi-aventis 4Q Profit Sinks 76% On Charge

Sanofi-aventis Appoints Jean-Pierre Lehner Chief Medical Officer

Schering-Plough Swings To 4Q Profit

Trial To Begin In Lawsuit Against Drug Company

USP Proposes Strengthened Partnership With HHS, FDA, To Help Protect Patients and Consumers

Vical Reports Positive Bird Flu Vaccine Trial Data

Warner Chilcott Announces Agreement to Acquire Topical Alprostadil Treatment for Erectile Dysfunction

Wisconsin Attorney General Hails Major Victory Against Pfizer Unit

Wyeth Deal Could Mean NJ Drug Industry Job Cuts
 
January 2009

Abbott Opens New Pharmaceutical Research Laboratory in Singapore

Actavis Receives Approval of Levetiracetam Oral Solution in the U.S.

Actavis To Shut Down Plants Until Issues Fixed

Akrimax Pharmaceuticals Announces Manufacturing Partnership

Amgen 4Q Profit Rises 15 Percent On Lower Costs

AMRI Appoints Director of Global Project Management

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

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

Boehringer Ingelheim Appoints Albert Ros as Executive Vice President of Sales and Marketing for Prescription Medicines

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

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

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

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

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

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%

Akorn, Inc. Enters into a Commercial Manufacturing Supply Agreement

Alnylam Earns $20 Million Payment from Takeda

AMAG Pharmaceuticals Receives Complete Response Letter from FDA for Ferumoxytol

Azopharma To Offer Microdosing Services

Bridge Laboratories Awarded Major Contract to Support the National Institute on Drug Abuse (NIDA)

Cardinal Tightens Drug Sales Oversight

Catalent Pharma Solutions Announces First FDA Product Approval for Brussels Syringe Facility

CEL-SCI Takes Delivery of New Manufacturing Facility

Consortium Established to Promote Patient Safety and Reduce Medication Errors

Daiichi Sankyo, Eli Lilly: New drug still on track

Diabetes Treatment Guidelines Change; Lilly/Amylin To Benefit?

Drug Industry Spends $13 Million On Thank-You Ads

EPA Honors Pfizer for Reducing Greenhouse Gas Emissions

ETHEX Corporation Voluntarily Recalls Three Lots of Dextroamphetamine Sulfate 5mg Tablets Due to the Potential for Oversized Tablets

FDA and PATH Malaria Vaccine Initiative Announce Research Collaboration

FDA Approves Duramed's LoSEASONIQUE(R) Oral Contraceptive

FDA Awards NIPTE $1.19 Million Contract to Develop Quality by Design (QbD) Guidance Elements

FDA Delays Decision On Abbott Cholesterol Drug

FDA Grants Orphan Drug Status to Reata's RTA 402 for Treatment of Pancreatic Cancer

FDA Issues Draft Guidance on Priority Review Vouchers

FDA Issues Warning Letters to Bayer HealthCare for Illegally Marketing Two Unapproved Drugs

FDA Licenses Drug to Prevent Joint Damage in Children with Hemophilia A

FDA Licenses For Marketing New Therapy for Rare Genetic Disease

FDA OKs Expanded Use of J&J Drug for HIV Patients

FDA Panel To Vote On New Version Of Genzyme Drug

FDA To Miss Review Deadline For PPD’s Alogliptin NDA

FDA will open inspection office in China this year

FDA, NCI, and CRIX International to Collaborate on FIREBIRD Pilot

FDA’s Blood Products Advisory Committee intends to review the BLA for ATryn

Forest, Cypress Face Delay In FDA Drug Review

Heritage Introduces Propranolol Tablets

ImClone Announces Merger Agreement with Eli Lilly at $70 Per Share

IMS Health Forecasts 4.5 - 5.5% Growth for Global Pharmaceutical Market in 2009

Johnson & Johnson Pharmaceutical Research & Development Submits NDA For Carisbamate

King Pharmaceuticals Extends Tender Offer to Acquire Alpharma

Lannett Announces Positive Results of Facilities Inspection

Lannett Receives Patent Approval for Method of Manufacturing Certain Morphine Derivatives

Laureate Announces Manufacturing Agreement with TolerX

Lilly and Amylin Enter Into Supply Agreement for Exenatide Once Weekly

Lilly Says EU Agency Opposes New Cymbalta Use

Medelis Expands Worldwide CRO Services with New European Division Led by New Managing Director

Medicines Co. Expects Year Loss On New Drug Cost

Merck 3Q Net Drops 28 Percent; To Cut 7,200 Jobs

Merck Dedicates Durham Vaccine Manufacturing Facility in Honor of Merck Scientist Maurice R. Hilleman, Ph.D.

Millipore Opens New Manufacturing Facility in Ireland

Neurotech Opens GMP Manufacturing Facility in Cumberland, Rhode Island

Perrigo Licenses Prescription Brands to Medimetriks Pharmaceuticals

Pfizer Names New Head of Clinical Development and Medical Affairs for Its Oncology Business Unit

Pfizer Reaches Agreements in Principle to Resolve Litigation Involving Its NSAID Pain Medications

Pharmatech Associates Leads Design for First FDA-licensed Biomanufacturing Facility in China

Pozen Stock Tumbles As Patent Challenge Announced

Reports of Serious Drug Reactions Hit Record

Safety Concerns and Labeling Changes for Psoriasis Drug Raptiva

Study Reports Companies Now Outsource Less Of Clinical Development Budget

Study Reveals Clinical Trial Design Holds Key to Improved Drug Development Efficiency

Study Reveals That Only 59% Of Pharma Companies Own Dedicated Compliance Departments

Synta Earns $25 Million from GSK for Achieving Elesclomol Milestones

Teva Announces FDA Approval and Commercial Launch of Fentanyl Transdermal System

Valeant Pharmaceuticals Completes Acquisition of Coria Laboratories, Ltd.

Valeant Received Upfront Payment From GSK

VioPharma completes buy of Lev Pharmaceuticals

WuXi PharmaTech Expands Collaboration for Fully Integrated Services
 
September 2008

AAIPharma Appoints New Chief Operating Officer

ACORN Contract Research Organization Appoints Tara Webb as Senior Director of CRO Business Development

Alpharma Board Rejects King Pharmaceuticals' Unsolicited Tender Offer as "Financially Inadequate"

Alpharma Urges Shareholders to Take No Action with Respect to King Pharmaceuticals' Announced Intent to Commence a Tender Offer

Association of Clinical Research Organizations (ACRO) Welcomes Two New Member Companies

AstraZeneca Receives Six Months Pediatric Exclusivity for CASODEX(R) from the FDA

Bilcare GCS Expands Phase III Clinical Trial Service Capabilities

Cardinal Health Plans to Spin Off Clinical and Medical Products Businesses

Celator Pharmaceuticals Receives Orphan Drug Designation for Anticancer Agent CPX-351

Cellexus Limited Acquires Assets of Cellexus Biosystems Plc and Forms New Management Team

Dr. Reddy's Formally Announces its US Specialty Business, Promius Pharma, LLC.

Dynavax Awarded $17 Million Contract from National Institutes of Health

Emergent BioSolutions Signs Contract with BARDA/NIAID To Fund Development Of Next Generation Anthrax Vaccine

Emerson Process Management Announces New Executive Appointments

Encorium Group Signs $6.2 Million of New Contracts Mainly for Vaccines Clinical Trials

Enobia Pharma Receives FDA Orphan Drug Designation for

FDA Approves Expanded Uses for Gardasil

FDA Approves Six Vaccines For The 2008-2009 Flu Season

FDA Approves Treatment for Rare Neurologic Disease

FDA Completes Audit of Azopharma’s Cyanta Analytical Laboratories Facility

FDA Issues Warning Letters to Ranbaxy Laboratories Ltd., and an Import Alert for Drugs from Two Ranbaxy Plants in India

FDA Launches New Web Sites On Medical Product Promotion

FDA to Post Quarterly Report of Potential Safety Issues

FDA Updates Health Information Advisory on Melamine Contamination

FDA Warns Companies to Stop Marketing Unapproved Ophthalmic Balanced Salt Solution Drug Products and Topical Drug Products Containing Papain

FDA: Manufacturers of TNF-Blocker Drugs Must Highlight Risk of Fungal Infections

Genzyme Opens New Science Center

Honeywell's Jack Bolick Earns Lifetime Achievement Award From Frost & Sullivan

Indian Pharma Outsourcing Industry To Cross $2.5 bn By 2012

MannKind Dedicates New Manufacturing

Metrics VP Adds Pharm.D. To Professional Credentials

NicOx Signs Agreement With Capsugel For The Manufacture of Naproxcinod Oral Capsules

Norwich Pharmaceuticals Selects SupplyScape Nexus for Product Serialization

NovaQuest Receives Lilly’s 'Global Sustained Supplier Award'

Octagon Joins CDISC In Innovative Education Initiative For FDA Reviewers

Roxane Laboratories, Inc. Launches Protriptyline HCl Tablets, USP

Sun Pharma’s Generic Fosamax Tablets Approved

Surefil Adds Third Production Line

Teva and Barr Receive FTC Request for Additional Information

Tris Pharma Completes Its Facilities' Expansion; Receives FDA Clearance

UMass Lowell Opens New BioManufacturing Pilot Plant
 
August 2008

AAI Pharma Appoints New Leader For N. American Biostatistics and Data Management Services

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

Banner Receives FDA Approval for Valproic Acid Delayed Release Softgel Capsules

Bilcare GCS Opens New Global U.S. Headquarters

BioDelivery Sciences Anticipates First Half 2009 Approval of BEMA™ Fentanyl (ONSOLIS™)

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

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

AAPS Names Inchauteguiz Associate Executive Director

Azopharma Product Development Group and Accu-Break Pharmaceuticals, Inc. Announce Strategic Alliance Partnership

Carbamazepine Prescribing Information to Include Recommendation of Genetic Test for Patients with Asian Ancestry

FDA Advisory Panel Recommends Against Approval of Merck's NDA for Non-prescription MEVACOR®

FDA Approves Kuvan for Treatment of Phenylketonuria (PKU)

FDA Approves New Beta Blocker to Treat High Blood Pressure

FDA Approves New HIV Drug After Priority Review

FDA Approves Tysabri to Treat Moderate-to-Severe Crohn's Disease

FDA Grants Tentative Approval to First Generic for Antiretroviral Viread

FDA Takes Action Against Compounded Menopause Hormone Therapy Drugs

FDA's Safety Reviews of Prilosec and Nexium Find No Evidence of Increased Rates of Cardiac Events

Idera Pharmaceuticals and Merck KGaA to Collaborate on Cancer Treatment

Malvern Instruments Acquires Viscotek Corporation

Millipore and Novozymes Form Alliance to Supply Animal-Free Cell Culture Supplements for Bioprocessing

Pfizer to Acquire CovX to Extend Biotherapeutics Investment

Precision Pharma Services Merges Into Talecris Biotherapeutics

Saint-Gobain Finalizes Agreement to Acquire IFK Isofluor GmbH
 
December 2007

ABILIFY® Approved for Adolescent Patients With Schizophrenia

Drugs and Dietary Supplements Seized From St. Louis Company

FDA Approves Nonprescription Zyrtec-D for Allergies, Colds

FDA Requests Marketing Suspension of Trasylol

FDA Requests Recall of Dietary Supplements

FDA Says Consumers Continue to Buy Risky Drugs Online

FDA Strengthens Boxed Warnings, Approves Other Safety Labeling Changes for Erythropoiesis-Stimulating Agents (ESAs)

Kiadis Pharma's Lead Product Granted Orphan Drug Designation

Premier Healthcare To Assist FDA In Evaluating Drug Risks

Sanofi Pasteur Initiates Phase II Trial of Cell Culture-Based Seasonal Influenza Vaccine
 
November 2007

Dey L.P. and Critical Therapeutics Launch Twice-Daily ZYFLO CR™ Extended-Release Tablets for the Chronic Treatment of Asthma

FDA Announces Revisions to Labels for Cialis, Levitra and Viagra

FDA Approves First Generic Versions of Trileptal

FDA Approves Genzyme's Renvela™ Tablets for Dialysis Patients

FDA Approves IXEMPRA™ For The Treatment of Advanced Breast Cancer

FDA Approves New 300mg Loading Dose Tablet for PLAVIX®

FDA Expands Age Range for Use of Bacterial Meningitis Vaccine

Health Canada Approves ATRIPLA® As A Once-Daily Single Tablet Regimen for HIV

Sanofi Pasteur Receives FDA Approval of Meningococcal Vaccine for Children
 
October 2007

AHRQ and FDA to Collaborate in Largest Study Ever of Possible Heart Risks With ADHD Medications

FDA Accepts New Drug Application for Priority Review of Investigational HIV Treatment TMC125

FDA Appoints Coté to Head Orphan Products Development Office

FDA Approves First Generic Versions of Coreg

FDA Approves New Uses for Evista

FDA Grants Orphan Drug Status to Immtech's Pafuramidine for Treatment of African Sleeping Sickness

FDA Proposing Phase Out of CFCs in Metered-Dose Inhalers for Epinephrine

FDA Warns Procter & Gamble about Unlawful Marketing of Product for School Children

Meditrina Pharmaceuticals, Inc. Announces Exclusive Global Manufacturing Agreement With Pfizer CentreSource (PCS) for Femathina™

New Data Show That GlaxoSmithKline's Rotarix® Could Be Given With Other Routine Infant Vaccines in the U.S.
 
September 2007

Canadian Business Leader Purchases Assets Of Mathis Instruments And Launches C-Therm Technologies Ltd.

Environmental Tectonics Corporation's Sterilization Systems Division Forms New Operational Group and Expands Service Offerings

FDA Approves Novel Antiretroviral Drug

FDA Approves Updated Warfarin (Coumadin) Prescribing Information

GSK's Application for Rotarix® is Accepted for Review by the FDA

Healthcare Organizations Launch Disaster Response Initiative

Manufacturers of Some Diabetes Drugs to Strengthen Warning on Heart Failure Risk

Millipore and Novo Nordisk Expand Agreement to Supply Biopharm Market with Recombinant Human Insulin

Reclast® Receives FDA Approval For Treatment of Women With Postmenopausal Osteoporosis

Sanofi pasteur First Manufacturer to Ship Doses of Influenza Vaccine for the 2007-2008 Season

Total Solution Provider for Next Generation Biomanufacturing
 
August 2007

Caraco Pharmaceutical Laboratories, Ltd. Announces Tentative FDA Approval for Generic Provigil®

FDA Approves First Drug for Treating Fibromyalgia

FDA Approves First Generic Versions of Lamisil Tablets

FDA Grants Fast Track Designation to Cardium's Phase 3 Angiogenic Gene Therapy for Heart Disease

Glatt To Host Solid Dosage Symposium

Nabi Biopharmaceuticals Announces Creation of Pharmaceuticals Business Unit

New Report Offers A Detailed Analysis of the Leading Players in the Indian Pharmaceutical Market

PennTech Machinery Corporation And Shanghai Tofflon Sign Joint Venture

Pfizer Receives Positive Opinion from CHMP for Celsentri®

Schering-Plough Announces Licensing of Acadesine, an Investigational Agent Being Studied for Prevention of Complications From Cardiac Surgery
 
July 2007

Bradley Pharmaceuticals Launches Authorized Generic of ADOXA®

Cephalon Receives FDA Approval of NUVIGIL™ for the Treatment of Excessive Sleepiness Associated with Three Disorders

FDA Approves New Orphan Drug for Treatment of Pulmonary Arterial Hypertension

FDA Grants Priority Review for Bristol-Myers Squibb's Investigational Oncology Treatment Ixabepilone

FDA Grants Priority Review for Oral Formulation of HYCAMTIN® (topotecan) to Treat Relapsed Small Cell Lung Cancer

Kurve Technology and Schering-Plough Sign Expanded Technology Agreement

Neurocrine Announces Resubmission of NDA for Indiplon Capsules

Outsourcing to Biotechs Is the Answer for Many Pharma Companies' Development Woes

Regulatory Cooperation Expanded

Sciele Pharma Completes Acquisition of Alliant Pharmaceuticals
 
June 2007

ANI Pharmaceuticals, Inc. Acquires State-of-the-Art Rx Facilities and Inks Long-Term Supply Agreement with Solvay Pharmaceuticals

AstraZeneca to Begin Construction of $100M R&D Expansion

Bristol-Myers Squibb Breaks Ground on new Biologics Manufacturing Facility in Massachusetts

FDA Advises Manufacturers to Test Glycerin for Possible Contamination

FDA Advisory Committee Finds Substantial Evidence to Support Advair 500/50 in Reducing COPD Exacerbations

FDA Approves First Generic Versions of Ambien for Insomnia

FDA Approves First U.S. Vaccine for Humans Against the Avian Influenza Virus H5N1

FDA Approves Oscient Pharmaceuticals' FACTIVE® Tablets for Five-Day Treatment of Community-Acquired Pneumonia

Major Manufacturer of Unapproved and Adulterated Drugs Agrees to Stop Illegal Practices

New Critical Path Report Highlights Research Needed to Foster Generic Drug Development
 
April 2007

FDA Approves New Drug Treatment for High Blood Pressure

FDA Approves TYKERB® in Combination With Xeloda® for the Treatment of Advanced or Metastatic Breast Cancer

FDA Extends Marketing Exclusivity for LEVAQUIN®

FDA Takes Action to Halt Marketing, Manufacturing and Distribution of Illegal Drugs to Treat Migraine Headaches

Report Says New Drugs from Novartis and Daiichi Sankyo Will Achieve Blockbuster Status in the Hypertension Drug Market

Roche Files Supplemental New Drug Application for Tamiflu® 30 mg and 45 mg Capsules

Spectrum Pharmaceuticals Reaches Special Protocol Assessment Agreement With FDA on Phase 3 Trials for EOquin®

Sucampo Pharmaceuticals Initiates Post-Marketing Studies of AMITIZA® in Subjects with Renal or Hepatic Impairment

Teva Receives Approval for Generic Dostinex® Tablets
 
March 2007

Aptuit Completes Acquisitions of EaglePicher Pharmaceutical Services and SSCI

Critical Path Liver Toxicity Biomarker Study to Commence with Participation from Seven Pharmaceutical Companies

FDA Announces Label and Indication Changes for the Antibiotic Ketek

FDA Approves Orlistat for Over-the-Counter Use

for Post-Exposure Prophylaxis Against Anthrax Infection

Manufacturing Facility

Merck and Nano Terra LLC Announce New Nanotechnology Solutions Alliance

Nortec Announces FDA Approval Of Its Generic Inderal-La Licensed To Par Pharmaceutical

Two Baxter Facilities Recognized With Shingo Prize For Excellence In Manufacturing

USP Publishes Standards for Medications for Neglected Diseases
 
February 2007

Astellas Pharma US, Inc. Announces Availability of MYCAMINE 100mg Vial

AstraZeneca Announces RECENTIN as Global Trademark for AZD2171

Bristol-Myers Squibb and AstraZeneca Announce Worldwide Collaboration to Develop and Commercialize Diabetes Compounds

Double-Digit Growth Drives Oral Drug Delivery Market to $52 Billion by 2010

FDA Approves First Generic Ondansetron Tablets, Orally Disintegrating Tablets and Oral Solution

FDA Approves New Drug for Schizophrenia

FDA Proposes Labeling Changes to Over-the-Counter Pain Relievers

Genentech Again Named One of FORTUNE's 100 Best Companies to Work For

Genzyme Reports Strong Fourth-Quarter Revenue Growth

MediVas and PacificGMP Announce Collaboration on Novel Therapeutic Vaccines
 
January 2007

Alcan To Invest $27.5 Million In Shelbyville, Kentucky Pharmaceutical Packaging Center

Deputy Commissioner for Medical and Scientific Affairs to Leave FDA

FDA Approves VELCADE® for Injection for Aggressive Form of Non-Hodgkin's Lymphoma

FDA Proposes Rules Overhaul to Expand Availability of Experimental Drugs

FDA Warns Five Firms To Stop Compounding Topical Anesthetic Creams

Forecast Predicts Ceftobiprole Will Achieve Sales of Nearly $500 Million by 2015 for Treating Hospital-Acquired Infections

GlaxoSmithKline to Acquire Domantis

Merck and Idera Sign Collaboration Agreement Incorporating Idera's Toll-like Receptor Agonists in Merck's Vaccine Programs

Oracle Acquires TOLAS Healthcare Packaging

Stantec’s Dave DiProspero awarded ISPE Member of the Year Award
 
December 2006

Bavarian Nordic Reports Progress in New Smallpox Vaccine Program

Bayer Outlines New Global R&D Structures; U.S. Pharma Sites and Future Headquarters

DPT Laboratories Opens New R&D, Manufacturing And Distribution Facilities

Eisai Inc. Breaks Ground for New Oncology Facility in Research Triangle Park

FDA Approves New Treatment for Chronic Hepatitis B in Adults

FDA Approves New, Once-a-Day COREG CR for the Treatment of Three Key Cardiovascular Conditions

Par Pharmaceutical Announces Agreement With GSK to Settle Imitrex® Injection Patent Litigation

Samaritan Submits IND to FDA for Novel Anti-Amyloidal Alzheimer's Drug Candidate Caprospinol

Schering-Plough Expanding Discovery Operations in Cambridge, Mass.

World Orthopedic Drug Market Expected to Surge Past $44 Billion by 2010
 
November 2006

Cobra Signs Agreement With US Naval Medical Research Center To Evaluate Cobra’s Oral Vaccine Delivery Platform

Combination Therapy for Lung Cancer Approved by FDA

FDA Approves Expanded Use of Treatment for Patients With Severe Alzheimer's Disease

FDA Approves NEXIUM for the Treatment of Zollinger-Ellison Syndrome

Next-Generation Contraceptive Patch Now in Development

Office of Generic Drugs Moves to the Division File System

PharmAthene and Medarex Announce $1 Million Congressional Appropriation for Continued Development of Anthrax Therapeutic Valortim

Phase 3 Clinical Trial Costs Exceed $26,000 per Patient

Sanofi Pasteur to Deliver 50 Million Doses of Influenza Vaccine to U.S. Market for 2006-2007 Season

Zolinza Approved for Skin Cancer
 
October 2006

Advancis Pharmaceutical On Track to File NDA for Amoxicillin PULSYS

Eighty Percent of U.S. Adults Favor Allowing Importation of Prescription Drugs, According to Poll

FDA Approves First Generic Ciprofloxacin Injection, USP

FDA Approves NOXAFIL(R) Oral Suspension For Prevention Of Life-Threatening Fungal Infections In High-Risk Patients

FDA Proposes New Rule To Automate Drug Registration And Listing

GSK Settles Transfer Pricing Tax Dispute with IRS

Iomai Receives FDA Clearance for Study Comparing Flu Vaccine Patch to Traditional Injectable Vaccine

More Than 100 Million Doses of Influenza Vaccine Expected to be Available This Year

Pfizer's Lyrica® Approved In Europe For Difficult-to-Treat Nerve Pain

Plavix Approved For Use In Patients With Common Form Of Heart Attack
 
September 2006

American Lung Association Collaborates With Leading Vaccine Manufacturer on New Initiative

FDA Announces Plan to Strengthen Advisory Committee Processes

FDA Approves First Generic Meloxicam

FDA Approves Influenza Vaccines To Be Manufactured for Upcoming Flu Season

FDA Approves Oncaspar For Newly-Diagnosed Acute Lymphoblastic Leukemia

First Medical Director Named For Emerging And Pandemic Threat Preparedness In The Center For Biologics Evaluation And Research

Initiation of Phase I Clinical Trial with Alzheimer's Disease Drug Product AZD-103 Given FDA Clearance

MedImmune Begins Shipping FluMist for 2006-2007 Flu Season

Proposed Legislation Aims to Stem the Flow of Counterfeit Prescription Drugs

Supplemental New Drug Application for Famvir Approved By FDA
 
August 2006

Abbott and AstraZeneca Announce Collaboration to Develop and Commercialize CRESTOR® and Next-Generation TriCor® (ABT-335) Fixed-Dose Combination

FDA Announces New Initiative to Modernize the Regulation of Clinical Trials and Bioresearch Monitoring

FDA Approves First Generic Sertraline

FDA Approves Lilly's Gemzar® For Ovarian Cancer Treatment

Javelin Pharmaceuticals Wins Phase II SBIR Grant

New Biologic Treatment for Wet Age-Related Macular Degeneration Approved By FDA

New HIV Treatment for Patients Who Do Not Respond to Existing Drugs Approved By FDA

TG100-115 Cardiovascular Compound Receives Fast Track Designation

Three-Component AIDS Drug Given Tentative FDA Approval

Vertex and Janssen Form Collaboration to Develop and Commercialize VX-950 for Treatment of Hepatitis C
 
July 2006

Azilect Approved For Treatment of Parkinson's Disease

FDA Acts to Improve Drug Safety and Quality By Strengthening its Efforts on Unapproved Prescription Drug Products Containing Carbinoxamine

FDA Approves Resumed Marketing of Tysabri Under a Special Distribution Program

FDA Licenses New Vaccine for Prevention of Cervical Cancer

GeoVax Launches Clinical Human Trials for its HIV/AIDS Vaccine Developed at GeoVax Inc., Emory University, NIH and the CDC

Life Science Pharmaceuticals Acquires Three Clinical Stage Monoclonal Antibody Programs From the Ludwig Institute for Cancer Research

TetraLogic Pharmaceuticals Completes $36 Million Series B Financing

Teva Pharmaceuticals to Invest $6 Million in CureTech For Development of a Revolutionary Cancer Drug

West Pharmaceutical Services Names Fran DeGrazio Vice President, Marketing and Strategic Business Development

Zostavax Licensed by FDA to Reduce Older Americans’ Risk of Shingles
 
May 2006

Acuity Pharmaceuticals Licenses Broad Spectrum Anti-Infective for Ophthalmic Use

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

FDA Approves First Generic Pravastatin

FDA Names First Director of Drug Safety Policy and Communication

FDA Signs Arrangement With Sweden’s Medical Products Agency

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
 
April 2006

AstraZeneca and University of Pennsylvania School of Medicine to Collaborate on Research

Dalton Pharma Services Announces Completion Of Its GMP Oligonucleotide Manufacturing Facility

Experts to Evaluate Drug and Medical Device Advertising at Conference

FDA Approves Methylphenidate Patch to Treat Attention Deficit Hyperactivity Disorder in Children

FDA Awards Contract to Assess Postmarketing Study Commitment Decision-Making Process

GlaxoSmithKline Begins Testing New Technology to Protect Patients Against Counterfeit Medicine

Lilly Announces Senior Leadership Changes

Ranbaxy Acquires Romanian Pharma Company Terapia

TAXOTERE® Receives U.S. FDA Approval For Use In Advanced Stomach Cancer

Transpharma-Medical Announces Promising Results Of Clinical Trials With Its Hpth (1-34)-Transdermal Delivery Product For Osteoporosis Treatment
 
February 2006

Accentia Biopharmaceuticals Amends and Submits Fast Track Application for SinuNase

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

Report Demonstrates Benefits of Earlier Meetings with FDA to Make Drug Review Process More Efficient

SCIREX Appoints Dr. Susan Shelby Executive Director, Clinical Trials Management

Unigen Pharmaceuticals Hires Director of Clinical Research

Vaccinex, Inc. Announces Antibody Collaboration with Schering AG
 
January 2006

AstraZeneca and M. D. Anderson Cancer Center Form Umbrella Scientific Collaboration Agreements

AstraZeneca Submits sNDA for SEROQUEL® for Bipolar Depression Treatment

Bradley Pharmaceuticals Announces Establishment of A. Aarons, Its Authorized Generic Subsidiary

FDA Appoints New Acting Director for National Center for Toxicological Research

FDA Approves Tamiflu for Prevention of Influenza in Children Under Age 12

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
 
December 2005

Alliant Pharmaceuticals Appoints Two to Corporate Positions

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

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

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
 
October 2005

Amarin Receives Special Protocol Assessment From FDA For Two Pivotal Phase III Clinical Trials For Miraxion In Huntington's Disease

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
 
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

Targeted Genetics Announces Appointment of Roger L. Hawley, An 18- Year Pharmaceuticals Industry Veteran, to Its Board of Directors

VistaGen Therapeutics Secures Development Support for New Drug Candidate for Huntington's Disease
 
July 2005

$1.3 Million Phase II SBIR Grant Enhances Velcura Therapeutics®, Inc.'s Research to Find New Drugs for People with Osteoporosis

Aptuit to Acquire Quintiles’ Pharmaceutical Sciences, Preclinical Services and Clinical Trial Supplies

Clive V. Bennett Appointed President, Patheon U.S.A. and President and Chief Operating Officer of MOVA Pharmaceutical Corporation

Crawford Confirmed by Senate to Lead FDA

FDA Issues Public Health Advisory on the Fentanyl Patch

GlaxoSmithKline Exercises Option to LymphoStat-B™

GSA/FDA Dedicate Center for Drug Evaluation and Research (CDER) Office Building I in White Oak, Maryland

HHS/FDA Tentatively Approves Another First-Time Generic AIDS Drug Associated with the President’s Emergency Plan for AIDS Relief

Millipore Acquires European Contract Testing Lab

Millipore to Acquire NovAseptic AB; Broaden Offering to Biotech and Pharmaceutical Companies

OnSource Corporation Changes Name to Ceragenix Pharmaceuticals

Preliminary Phase I/II Study Showed Lucentis™ Improved Vision in Patients With Wet Age-Related Macular Degeneration When Used in Combination With Visudyne®

Schering-Plough Expands Its Presence in Asia Pacific; Commercial Operations Opened in Korea and Pakistan

SCIREX Appoints Robert R. Allen, M.D., as Executive Officer, Science and Medicine
 
June 2005

Actavis To Acquire US Generics Company Amide

Alpharma Announces Agreement with Indian Firm Shasun to Develop and Manufacture Generic Prescription and API Products

BioCryst Receives FDA Fast Track Status for Fodosine™ in the Treatment of Relapsed or Refractory T-cell Leukemia

BioMarin Announces FDA Approval for Naglazyme

Cardiovascular Drug Market to Top $100 Billion by 2008

Eisai Inc. Announces Appointment of Vice President of Production Operations

Epilepsy Foundation Says FDA Pregabalin Approval a Much Anticipated And Welcome Development

FDA Licenses sanofi pasteur's ADACEL™ Vaccine for Combined Protection Against Tetanus, Diphtheria and Pertussis

FDA to Use Ingenuity Pathways Analysis in Review of Pharmacogenomics Submissions

First Tuberculosis Drug Developed by a Non-Profit Begins Clinical Trials

Interpharma, Quintiles and Temasek to Form Pharma Commercialization Joint Venture in Asia Pacific With US $112 Million Investment Fund

INTERPHEX Puerto Rico Call For Presentations

Medarex and Boehringer Ingelheim Announce Antibody Development Agreement

Mylan Laboratories Receives Approvable Letter For Its Next Generation Beta-Blocker Nebivolol

OSG Norwich Pharmaceuticals Names New President

Peregrine Pharmaceuticals Receives FDA Clearance to Initiate Tarvacin™ Anti-Viral Clinical Trial

Pfizer Global Manufacturing Names Pete Stevenson Vice President For Contract Manufacturing/Procurement/Pfizer Centresource

Pfizer to Acquire Vicuron Pharmaceuticals to Extend its Research Commitment in Anti-Infectives

Pharmaceutical Profiles’ Wilding To Receive Award From Controlled Release Society

Spectrum Authorized by FDA to Conduct Phase I/II Clinical Trial in the U.S. With SPI-153 in Hormone Dependent Prostate Cancer
 
May 2005

American Urological Association Honors Novartis Pharmaceuticals With Annual Health Science Award

AmerisourceBergen Promotes Michael D. Dicandilo To Executive Vice President And Chief Financial Officer

Bayer and Onyx Initiate Phase III Metastatic Melanoma Trial Studying Sorafenib (BAY 43-9006) in Combination With Two Chemotherapeutic Agents

FDA Grants SGX Orphan Drug Designation for Troxatyl™ SGX to Present Troxatyl™ Clinical Data at ASCO

Genta and Aventis Terminate Genasense® Agreements

HHS Awards BioShield Contract for AVA Anthrax Vaccine

Icoria Names Doug Morton Interim CEO, Makes Management Changes to Focus on Healthcare

Merrimack Pharmaceuticals Appoints Gary L. Crocker as Chairman of the Board

Novartis Files Exjade New Drug Applications for Treatment of Chronic Iron Overload Due to Blood Transfusions

Smith & Nephew Receives US FDA Clearance for ACTICOAT™ Moisture Control

Southern Research Institute Announces Joint Drug Discovery Program With Schering-Plough to Seek Novel Drug Compounds

Tm Bioscience Receives FDA Clearance For Cystic Fibrosis DNA Test

Vaccine to Treat Nicotine Addiction Achieves Proof of Efficacy in Phase II Clinical Trial

Vitex Announces Management Change
 
April 2005

(Zolpidem Tartrate Extended Release) CIV for the Treatment of Insomnia

Anthera Pharmaceuticals Launches With a Proven Leadership Team and Significant Series A Funding

Arakis and Vectura Announce Agreement on New Therapy for Respiratory Disease

Data in Clinical Cancer Research Article Shows that Peregrine's Lead VEA Compound Enhances Efficacy of Multiple Chemotherapeutic Agents

Dr. Darrell Abernethy Elected President of the USP Convention

FDA Approves New FOSAMAX PLUS To Reduce The Risk Of Both Hip And Spine Fractures

Global Pharmaceutical Services Organization and eClinical Software Provider Partner to Improve the Late-Phase Clinical Trial Process

Guilford Pharmaceuticals Restarts AQUAVAN®, Clinical Development Program

ImmuneRegen BioSciences Appoints Dr. Paul Carlton to Bioterrorism

Jeffrey W. Henderson to Become Cardinal Health CFO

Kaferle Named Director of Projects for Somerset Office

MedImmune Begins Dosing in Phase 1 Clinical Trial for Nasally Delivered Vaccine Designed to Help Prevent Common Childhood Respiratory Viral Diseases

Multiple Second-Generation Antisense Drugs Effectively Inhibit Tumor Growth and Show Potential as New Anti-Cancer Drugs

Par Pharmaceutical Receives Approval to Market Generic Ultracet®

Peter F. Drake Joins Penwest Board Of Directors And Jere E. Goyan To Retire

Pharmos Corporation Strengthens Management Team to Support Pipeline Development

Prana Biotechnology Cancels Plans for PLACQUE Clinical Study

Protein Design Labs Reports Positive Results in Phase II Clinical Trial (SIRIUS II) of Ularitide for Decompensated Congestive Heart Failure

Roche Files Supplemental New Drug Application to Extend Prophylaxis Indication for Tamiflu to Patients Between One to 12 Years of Age

Study Shows Common Painkillers Combined With Acid-Reducing Drugs More Cost-Effective, Safer for Managing Arthritis in High-Risk Patients

Target Announces That All Products Containing Pseudoephedrine Will Be Placed Behind Pharmacy Counter

Tarvacin™ Equivalent (3G4) Plus Radiation Reduces Lung Tumor Growth By Over 95%

Therapy During Primary Total Hip Replacement Surgery

TOPIGEN Appoints Biopharmaceutical Industry Executives

USP to Publish Spanish Translation of USP – NF
 
March 2005

Amarin Corporation Announces Additional Positive Clinical Data for Miraxion™ To Treat Unresponsive Depression

Antares Pharma Files IND for Its First Proprietary Pharmaceutical Product - Transdermal Gel to Treat Overactive Bladder Syndrome

BioCryst Pharmaceuticals Successfully Completes Phase I Trial With Oral BCX-4208 for Psoriasis

Dow Stake Positions DNT and Starpharma as Leading Developers of Nanotechnologies for the Pharmaceutical, Biotechnology Industries

Drug Information Association Names New Executive Director

FDA Accepts ACEON Supplemental New Drug Application for Filing

FDA Announces Dates for Public Meeting on Non-Steroidal Anti-Inflammatory Drugs

FDA Approves First Gene-Based Test, UroVysion™ for Diagnosis of Patients Suspected of Having Bladder Cancer

FDA Clears the Way for Generic Versions of Transdermal Patches to Treat Chronic Pain

FDA Rejects Public Citizen's Petition for AstraZeneca's CRESTOR®

Interim Analysis of Phase III Trial Shows Avastin Plus Chemotherapy Extends Survival of Patients With First-Line Non-Squamous, Non-Small Cell Lung Cancer

La Jolla Pharmaceutical Announces Outcome of Recent FDA Discussions

New Chromium Supplementation Clinical Trial Initiated - First to Study Effects in Overweight Children with Type 1 Diabetes

Partnership With Pfizer

QuatRx Pharmaceuticals Licenses Novel Lipid-Lowering Drug

Reforms Will Improve Oversight and Openness at FDA

Spectrum Pharmaceuticals Announces the Hiring of Dr. Rudi E. Moerck as Consultant

USP Receives ISO 17025 Accreditation for Compliance in Science Laboratories

USP to Establish Site in India

USP to Publish Spanish Translation of USP – NF
 
February 2005

‘Multivac University’ Announces 2005 Schedule

Clinical Trials May Face Patient Shortfalls in 2005

Conference Theme: Doing More With Less Through Technology

Cornerstone BioPharma and Adams Laboratories Enter Agreement

FDA Accepts ACEON Supplemental New Drug Application for Filing

FDA Clears Generic Versions of Transdermal Patches

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

Halozyme Therapeutics Signs Commercial Manufacturing Agreement

Lilly Announces Individual Bar Coding on All Insulin Vials

New Chromium Supplementation Clinical Trial Initiated

Pyro Pharmaceuticals to Receive Patent

Reforms Will Improve Oversight and Openness at FDA

TOPIGEN Initiates Phase I Study of ASM8, its Inhaled Asthma Product

USP to Establish Site in India

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

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

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...

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...

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

Philadelphia Conference to Focus on Recent FDA Announcements

Sanofi Merger With Aventis to Create No. 3 Drugmaker

USDA Approves Prionics ‘Mad Cow’ Tests

Warrick Pharmaceuticals Launches Generic Ribavirin Product

Wyeth, Solvay to Co-Develop Product Candidates and Co-Promote
 
March 2004

Abbott Labs Honors Employees For Exceptional Performance

Atrix to Distribute Dermatology Products in Canada

Biotech Holdings Sucanon drug facility nears completion

CEI Opens New Cleanroom Manufacturing Facility In Syracuse

Centocor to Acquire Wyeth Facility in St. Louis

Chiron to Discontinue Development of Tezacitabine

FDA Accepts SuperGen's New Drug Application for Filing

IMC expands lineup to include smart RFID closure

ISTA CEO to Speak at Biotech Industry Conference

James C. Mullen Elected to PerkinElmer Board

Logica Executive Chosen to Head Up Alltracel Alliance

Medical Services in Joint Venture For Chinese Production Facility

Millipore and HyClone Align to Optimize Biopharmaceutical Drug Production

Millipore Appoints Vice President of Worldwide Manufacturing Operations

MonoSol LLC and Kosmos Pharma Form MonoSolRX LLC to Commercialize Oral Film Strip Pharmaceutical Products

MRO Software and Stelex Announce Alliance to Help Manage Risk, Reduce Validation Costs for Customers in FDA Regulated Industries

PA Attorney General Sues 13 Major Drug Companies

Peregrine Publishes Article on Tumor Necrosis Therapy Technology

Pharmacy Alliance Gets Medicare Endorsement for Prescription Card

Roche Picks Genmab Antibodies For Clinical Development

Schering-Plough and Merck Cholesterol Tablet Approved in Mexico

Vaccine Maker Develops Application Using InBatch
 
February 2004

FDA Reports 9% Increase In NDA Filings In 2003

FTC Notification Requirement For Patent Settlements Now In Effect

IBM and FAST to jointly sell and market e-business solution to the life sciences market

Organizations Address Drug Distribution Quality Control Problems

Pilgrim And Stelex To Help Life Science Companies Achieve Operational Excellence

Sparta Systems and Open Text Partner to Provide Solutions for Quality Management and Electronic Document Management

USP 27- NF 22 Becomes Official - Third Annual Edition Contains New Requirements

What you need to know today
 
January 2004

BioPoint Solutions, Inc. Established to Deliver Pre-Clinical Data Management and Workflow Enforcement for the Biotech and Pharmaceutical Marketplace

DFB Pharmaceuticals Acquires Phyton Inc., - World's Largest Plant Cell Fermentation Facility

Honeywell To Implement System at Boehringer Ingelheim Plant

Taste Technology Company Receives Funding For Further Research To Eliminate Bitter Taste In Oral Medicines
 
November 2003

Bayer and ComGenex Extend Drug Discovery Collaboration

FDA’s PAT initiative promises significant benefits in process efficiency, cost control and product quality

New Patent Covers Many Cancer Treatments

Thermo Electron Acquires Laboratory Services Provider LMSi

West Pharmaceuticals, Inc Appoints New Vice President of Business Development for Drug Delivery Division
 
October 2003

Klöckner Pentaplast Acquires Greenway Plastics Industries

USP Appoints New Director of Non-Complex Actives and Excipients
 
September 2003

Chase-Walton Promotes Tim Pryce to President
 
August 2003

Alfa Laval and Millipore Sign Joint USA Marketing Agreement

Anderson Instrument Co. Acquires Accurate Metering Systems, Inc.

West Pharmaceutical Services, Inc. Appoints New Chief Financial Officer

West Pharmaceutical Services, Inc. Creates New Position To Strengthen Compliance Activities - Linda R. Altemus Appointed Vice President & Chief Compliance Officer
 
July 2003

Aventis Commits To Honeywell POMS MES 5.1 And Migration Services For Largest North American Operation

Chemir Acquires Lycoming Analytical Laboratories, Creates New Division: Chemir Pharma Services

Pepperl+Fuchs Acquires Bebco EPS

PPD Restructures Discovery Sciences to Better Align with Market Drivers

Revision Proposed to USP General Chapter <1> Injections

The Elizabeth Companies Appoint Logic TPS, Ltd as Their Exclusive Representative for Their Tooling Product Lines in the United Kingdom and Ireland

USP Examines Safety Issues Related to the Distribution of Drug Products
 
May 2003

FlexLink Introduces All-Stainless Pharmaceutical Packaging Solution
 
April 2003

IntraLinks Names Thomas Engel Vice President of Strategic Business Development for Life Sciences Industry

Latest Dust Explosion Kills Four, Hospitalizes Nine in Pharmaceutical Plant Disaster

Program for Operational Excellence In Regulatory Compliance

USP Names New Leader For Research & Development Laboratory
 
March 2003

ITT Industries Acquires BioPharm Manufacturing Division of Martin Peterson Company, Inc.

Roche Molecular Diagnostics selects Johnson Controls for $4.6 Million Technology, Validation Services Contract

USFILTER Introduces The New PREVUE(tm) System At INTERPHEX'03
 
February 2003

Entegris Inc. Acquires Electrol Specialties Company

USP's Pharmacopeial Forum (PF) Is Now Available Online
 
January 2003

Cambridge Major Laboratories Acquires Former Oread Pilot Plant Assets


 
Small Doses

Dear Santa...

by Mike Auerbach, Editor
Mike Auerbach, Editor Pharmaceutical Processing
Ok - yes - I'm too old to believe in Santa. But that won't stop me from putting together my own wish list.
You see, we are at interesting place in time. Not only is 2009 ending, but the first decade of the new century is also coming to a close. Is there a better time than now to look back at the first 10 years of the '00s, or the "aughts", or wh