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The Lead

Patheon Invests in Milton Park, UK Facility to Expand Early Development Capabilities in Europe

January 31, 2013 7:03 am | News | Comments

Patheon Inc., a provider of contract development and commercial manufacturing services to the global pharmaceutical industry, today announced plans for additional investment in its Milton Park facility.

Kemwell Announces Successful Pre-NDA US FDA Inspection

January 31, 2013 3:05 am | News | Comments

Kemwell Biopharma Pvt. Ltd., a global pharmaceutical contract development and manufacturing...

Study Sees Prostate Cancer Treatment Side Effects

January 31, 2013 3:01 am | by MARILYNN MARCHIONE,AP Chief Medical Writer | News | Comments

A new study shows how important it is for men to carefully consider treatments for early-stage...

Danish Novo Nordisk Profit Surges

January 31, 2013 2:56 am | News | Comments

Danish pharmaceutical company Novo Nordisk A/S has reported a 23 percent growth in fourth-quarter...

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Teva Announces Termination of Agreements with CureTech

January 31, 2013 2:54 am | News | Comments

Teva Pharmaceutical Industries Ltd. announced today the termination of its collaboration with CureTech Ltd.  

Tapemark Expands Capabilities for Transdermal Patches

January 31, 2013 2:49 am | News | Comments

Tapemark has announced the addition of several new capabilities for transdermal patches, including the formulation, blending, and coating steps in the patch manufacturing process.

Parexel Posts Higher Profit, Lifts Outlook

January 30, 2013 3:32 am | News | Comments

Pharmaceutical research contractor Parexel International Corp. said on Tuesday that its fiscal second-quarter earnings jumped 65 percent as the company's backlog of contracts grew.

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Vertex Swings to Loss on Weak Hep C Drug Sales

January 30, 2013 3:29 am | News | Comments

Vertex Pharmaceuticals Inc. swung to a loss in the fourth quarter as doctors turned away from the company's best-selling drug for treating hepatitis C.

FDA Gives New Drug Application Approval to Isis

January 30, 2013 3:27 am | News | Comments

Drug developer Isis Pharmaceuticals Inc. and partner Genzyme announced Tuesday that the U.S. Food and Drug Administration has approved their new drug application for Kynamro, clearing the way for Isis' first drug to reach market.

AbbVie Issues Inaugural Full-Year Outlook for 2013

January 30, 2013 3:24 am | News | Comments

AbbVie delivered strong sales growth with its marketed pharmaceutical products in 2012.  The proprietary pharmaceutical segment of Abbott, representing the majority of AbbVie's revenue, grew more than 8 percent globally on an operational basis.  

Metrics Names New VP of Pharmaceutical Development

January 29, 2013 3:19 am | News | Comments

Metrics Inc. has named Dr. Thomas B. “Brad” Gold vice president of pharmaceutical development.  

GSK and Biological E. to Develop Combination Vaccine for India and Other Developing Countries

January 29, 2013 3:12 am | News | Comments

GlaxoSmithKline (GSK) and Biological E Limited (Biological E.), an Indian vaccines company, today announced an agreement to form a 50/50 joint venture (JV) for the early stage research and development of a six-in-one combination pediatric vaccine.

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Repros Plunges on Testosterone Drug Study Delay

January 29, 2013 3:04 am | News | Comments

Shares of Repros Therapeutics Inc. plunged 40 percent Monday after the company said that results from a study of its testosterone drug Androxal will be delayed because it is removing some patients from the trial.

Eli Lilly 4Q Profit Slips But Tops Expectations

January 29, 2013 3:01 am | by TOM MURPHY,AP Business Writer | News | Comments

Eli Lilly and Co.'s fourth quarter earnings slipped 4 percent as generic competition continued to eat away at sales of its former best-seller, the antipsychotic Zyprexa, but the drugmaker cut expenses again and growth from other products helped it beat analyst expectations.

Nuvo Research Announces Settlement Agreement with Apotex in PENNSAID Generic Litigation

January 29, 2013 2:54 am | News | Comments

Nuvo Research Inc.announced today that it has entered into a settlement agreement with Apotex Inc. and Apotex Corp. (together Apotex) respecting patent infringement litigation brought by Nuvo and Nuvo's U.S. licensing partner, Mallinckrodt Inc. (Mallinckrodt), in response to Apotex's filing of an abbreviated new drug application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market a generic version of PENNSAID (diclofenac sodium topical solution) 1.5% w/w (PENNSAID).  

Pfizer Q4 Net Jumps on Sale of Nutrition Business

January 29, 2013 2:51 am | News | Comments

Pfizer Inc. says its fourth-quarter profit more than quadrupled, despite competition from generic drugs hurting sales, because of a $4.8 billion gain from selling its nutrition business.

Amneal Partners with Hanmi to Market Nexium® Alternative

January 28, 2013 2:56 am | News | Comments

Amneal Pharmaceuticals, LLC today announced that it has entered into a license and distribution agreement with South Korea-based Hanmi Pharmaceutical Co., Ltd to acquire exclusive distribution rights to Hanmi's new drug application (NDA), currently under FDA review, for esomeprazole strontium delayed-release capsules.

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Biogen Idec 2012 Revenue Increases 9% to $5.5B

January 28, 2013 2:53 am | News | Comments

Biogen Idec Inc. has announced full year and fourth quarter 2012 results.  

Novartis Europharm Withdraws Marketing-Authorization Application for Ruvise

January 25, 2013 3:07 am | News | Comments

The European Medicines Agency has been formally notified by Novartis Europharm Ltd of its decision to withdraw its application for a centralized marketing authorization for the medicine Ruvise.

US Hit By New Stomach Bug Spreading Around Globe

January 25, 2013 3:02 am | by MIKE STOBBE,AP Medical Writer | News | Comments

A new strain of stomach bug sweeping the globe is taking over in the U.S., health officials say.

Lawyer: Massachusetts Firm Tied to Meningitis Outbreak Paid Out $70M

January 25, 2013 2:58 am | by JAY LINDSAY,Associated Press | News | Comments

An attorney for creditors of a pharmacy blamed for a nationwide meningitis outbreak said Thursday that the firm paid out $70 million to company insiders over the last six years.

Orexo Enters Research Agreement with AstraZeneca for Respiratory Disease Program

January 25, 2013 2:50 am | News | Comments

Orexo AB announced today that the company has entered into an agreement with AstraZeneca regarding OX-CLI, a preclinical program for a potential novel treatment of respiratory diseases.

AAIPharma Appoints Senior Director of Parenteral Operations

January 24, 2013 4:44 am | News | Comments

AAIPharma Services Corp., a provider of pharmaceutical product development services, announced today that it has appointed James Fife as the company's senior director of parenteral operations for its manufacturing facility in Charleston, S.C.  

Scientists to Resume Work with Lab-Bred Bird Flu

January 24, 2013 3:06 am | by LAURAN NEERGAARD,AP Medical Writer | News | Comments

International scientists who last year halted controversial research with the deadly bird flu say they are resuming their work as countries adopt new rules to ensure safety.

Vanda Says Sleep Drug Met Goal In Clinical Trial

January 24, 2013 3:02 am | News | Comments

Vanda Pharmaceuticals Inc. said Wednesday that its sleep disorder drug tasimelteon worked in another late-stage clinical trial.

FDA Approves New Use of Avastin Plus Chemotherapy for People with Metastatic Colorectal Cancer

January 24, 2013 2:58 am | News | Comments

Genentech, a member of the Roche Group has announced that the U.S. Food and Drug Administration (FDA) has approved a new use of Avastin ® (bevacizumab) in combination with fluoropyrimidine-based irinotecan or oxaliplatin chemotherapy for people with metastatic colorectal cancer (mCRC).

Irvine Pharmaceutical Services Brings Avrio Parenteral Manufacturing Facility Under Irvine Brand

January 23, 2013 4:58 am | News | Comments

Irvine Pharmaceutical Services announced today that it is incorporating its Avrio parenteral manufacturing facility into the Irvine brand.

US Government Scientists Agree to Retire Most Research Chimps

January 23, 2013 3:12 am | by JANET McCONNAUGHEY,Associated Press | News | Comments

Government scientists have agreed that all but 50 of hundreds of chimpanzees kept for federally funded research should be retired from labs and sent to a national sanctuary.

Arena Slumps on Continued Concerns for Belviq

January 23, 2013 3:06 am | News | Comments

Shares of Arena Pharmaceuticals Inc. slumped Tuesday after the company said European Union regulators still have questions about its weight-loss drug Belviq.  

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