Log in | Register

E-mail
Company Name

News - October 2008

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

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

Oct 31 2008

The global pharmaceutical market is expected to grow 4.5 - 5.5 percent next year, a pace similar to 2008, according to the IMS Global Pharmaceutical and Therapy Forecast(TM) released by IMS Health (NYSE: RX).

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

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

Oct 31 2008

The FDA has awarded the National Institute for Pharmaceutical Technology and Education (NIPTE) a contract to develop Quality by Design guidance on design space specifications.

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

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

Oct 31 2008

Improved protocol design, perhaps more than any other drug development stratagem, holds the key to faster and more efficient development, according to the Tufts Center for the Study of Drug Development.

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

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

Oct 28 2008

The FDA has sent Warning Letters to Bayer HealthCare concerning two unlawful, over-the-counter (OTC) aspirin products - Bayer Women's Low Dose Aspirin + Calcium (Bayer Women's) and Bayer Aspirin with Heart Advantage (Bayer Heart Advantage).

Perrigo Licenses Prescription Brands to Medimetriks Pharmaceuticals

Perrigo Licenses Prescription Brands to Medimetriks Pharmaceuticals

Oct 28 2008

Medimetriks Pharmaceuticals has announced that the company has entered into a licensing agreement with Perrigo Company for the U.S. marketing rights to Centany(R) Ointment and two prescription keratolytic brands.

FDA Approves Duramed's LoSEASONIQUE(R) Oral Contraceptive

FDA Approves Duramed's LoSEASONIQUE(R) Oral Contraceptive

Oct 28 2008

Barr Pharmaceuticals, Inc. has announced that the FDA has approved its subsidiary Duramed Pharmaceuticals, Inc.'s New Drug Application (NDA) for LoSEASONIQUE(R) (levonorgestrel/ethinyl estradiol tablets 0.10 mg/0.02 mg and ethinyl estradiol tablets 0.01 mg) extended-cycle oral contraceptive.

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

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

Oct 28 2008

A new study by business intelligence firm Cutting Edge Information finds that only 59% of pharmaceutical companies currently own dedicated departments for compliance.

Lilly Says EU Agency Opposes New Cymbalta Use

Lilly Says EU Agency Opposes New Cymbalta Use

Oct 24 2008

INDIANAPOLIS (AP) _ A panel of European regulators have recommended against approving antidepressant Cymbalta as a treatment for the pain disorder fibromyalgia, drugmaker Eli Lilly and Co. said Friday.

Johnson & Johnson Pharmaceutical Research & Development Submits NDA For Carisbamate

Johnson & Johnson Pharmaceutical Research & Development Submits NDA For Carisbamate

Oct 24 2008

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) has submitted a New Drug Application (NDA) to the U.S.

Drug Industry Spends $13 Million On Thank-You Ads

Drug Industry Spends $13 Million On Thank-You Ads

Oct 24 2008

By KEVIN FREKING Associated Press Writer WASHINGTON (AP) _ The pharmaceutical industry is

ARCHIVES
    2010    Jan • Feb • Mar • Apr • May • June • July • Aug • Sept 
    2009    Jan • Feb • Mar • Apr • May • June • July • Aug • Sept • Oct • Nov • Dec 
    2008    Feb • Mar • Apr • May • June • July • Aug • Sept • Oct • Nov • Dec 
    2007    Jan • Feb • Mar • Apr • June • July • Aug • Sept • Oct • Nov • Dec 

Blogs

The Importance of Fundamentals

The Importance of Fundamentals

Aug 31 | Girish Malhotra, PE, President, EPCOT International

Globally, Johnson & Johnson is known for its integrity and product quality. A few years ago they handled the Tylenol situation extremely well and were commended for it. It is astounding that the year 2010 has become a nightmare for them.  

The Quality Control Unit: Invertebrates Need Not Apply

The Quality Control Unit: Invertebrates Need Not Apply

Aug 30 | The QA Pharm

The Quality Control Unit (QCU) is the only pharmaceutical function that has a job description codified in the CGMP regulations. Don’t you find this remarkable? In fact, an entire section is devoted to describing the responsibility of the QCU and how it is to operate within the organization—namely independently.        

Multimedia

Timothy Cote - Office of Orphan Products Development

Aug 13 | Root

From approving medicines to treating snake bites to Cystic Fibrosis - Dr. Tim Cote describes a special office at the FDA, designed to address needs of people with rare diseases. Timothy Cote, M.D. - Director, Office of Orphan Products Development

Charles River Labs On WuXi PharmaTech Acquisition

Charles River Labs On WuXi PharmaTech Acquisition

May 25 | Video

Charles Rivers Laboratories International Chief Officer talks about the recent WuXi PharmaTech acquisition

Biogen Idec - 2010 Facility of the Year Award Winner - Operational Excellence

Biogen Idec - 2010 Facility of the Year Award Winner - Operational Excellence

Apr 27 | Video

Peter Flinn, Biogen Idec's Senior Director, Global Project Engineering talks to Pharmaceutical Processing's Editor-In-Chief Mike Auerbach about the company's Large-Scale Manufacturing Technology Map Project in Research Triangle Park, North Carolina. The project won the 2010 Operational...

MannKind Corporation - 2010 Facility of the Year Award Winner - Equipment & Process Innovation

MannKind Corporation - 2010 Facility of the Year Award Winner - Equipment & Process Innovation

Apr 28 | Video

Juergen Martens, Ph,D. MannKind Corporation's Corporate Vice President and Chief Technical Officer talks to Pharmaceutical Processing's Editor-In-Chief Mike Auerbach durng INTERPHEX2010 about the company's Technosphere Insulin Manufacturing Facility located in Danbury, Connecticut. The...