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FDA Delays Decision on J & J Ovarian Cancer Drug

September 11, 2009 5:06 am | News | Comments

HORSHAM, Pa. (AP) — A unit of Johnson and Johnson said Thursday federal health regulators want more information on its experimental treatment for ovarian cancer before making an approval decision.

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Eli Lilly: Cymbalta Reduces Chronic Pain in Study

September 11, 2009 5:03 am | News | Comments

INDIANAPOLIS (AP) — Eli Lilly & Co. said Friday Cymbalta reduced pain over 41 weeks for patients with chronic lower back pain, as the drugmaker again tries to gain Food and Drug Administration approval for the new use.

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Amylin and Biocon to Partner on Diabetes Drug

September 11, 2009 5:00 am | News | Comments

NEW YORK (AP) — Amylin Pharmaceuticals Inc. said Thursday it will partner with Biocon Ltd. of India to develop and market a biotech diabetes drug. Terms of the collaboration were not disclosed. The companies said they will share development costs.

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FDA Allows Emergency Use of Generex Diabetes Drug

September 11, 2009 4:58 am | News | Comments

WORCESTER, Mass. (AP) — Generex Biotechnology Corp. said Thursday the Food and Drug Administration approved experimental use of its diabetes drug candidate Generex Oral-lyn.

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ZymoGenetics Says Rheumatoid Arthritis Drug Misses Advancement Goals

September 11, 2009 4:56 am | News | Comments

SEATTLE (AP) — ZymoGenetics Inc. said Thursday that its drug candidate Atacicept did not meet goals that would have automatically advanced it to late-stage clinical testing as a treatment for rheumatoid arthritis.

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China Says Swine Flu Spreading Inland

September 11, 2009 4:50 am | News | Comments

BEIJING (AP) — Swine flu is spreading in China from cities into rural areas, and from the coast inland, a health ministry official said Friday. Incidents of large-scale group infections are also replacing isolated ones, said Liang Wannian, deputy director of the Health Ministry's emergency office.

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Ascenta Therapeutics Receives FDA Clearance to Initiate Clinical Trials With AT-406

September 10, 2009 5:49 am | News | Comments

Ascenta Therapeutics announcedtoday that following the approval by the FDA of its Investigational

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Harvard study: Businesses Not Ready for H1N1 Flu

September 10, 2009 5:15 am | News | Comments

MARK PRATT Associated Press Writer BOSTON (AP) — Many American businesses are unprepared to deal with widespread employee absenteeism in the event of an outbreak of swine flu, according to a Harvard School of Public Health study released Wednesday.

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Obama Speech Leaves Health Care Industry Uncertain

September 10, 2009 4:50 am | News | Comments

NEW YORK (AP) — Shares of health insurers wavered in premarket activity Thursday after President Barack Obama made clear he is sticking to his goal of health care reform in a televised speech to a joint session of Congress Wednesday night.

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Apotex Working to Get FDA Import Alert Against Two Toronto Plants Lifted

September 10, 2009 4:42 am | News | Comments

TORONTO — Apotex Inc., the largest Canadian-owned pharmaceutical company, says it is working with U.S. regulators to correct problems at two of its plants in Toronto. The U.S. Food and Drug Administration has issued an import alert banning products from Apotex plants in North York and Etobicoke.

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FDA Panel Supports Glaxo's Cervical Vaccine

September 10, 2009 4:39 am | News | Comments

MATTHEW PERRONE AP Business Writer WASHINGTON (AP) — Drugmaker Merck probably will face U.S. competition for its vaccine Gardasil after federal experts recommended that rival GlaxoSmithKline's Cervarix also be approved to prevent the virus that causes most cervical cancers.

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FDA Backs Glaxo's Vaccine Cervarix for Women

September 9, 2009 10:43 am | News | Comments

WASHINGTON (AP) — Federal health officials favor approving GlaxoSmithKline's long-delayed vaccine Cervarix to prevent the leading cause of cervical cancer in U.S. women.

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Change Management Tool Enhances Quality, Streamlines Processes

September 9, 2009 5:57 am | Product Releases | Comments

Complexities within product lifecycles have led to a need for more efficient Change Management processes; Reliance is a workflow-centric system that is adept at managing these complex issues and enhancing processes of change management at every phase of the product lifecycle.

Genzyme to Buy Manufacturing Assets From Targeted Genetics Corporation

September 9, 2009 5:02 am | News | Comments

Targeted Genetics Corporation today announced the sale to Genzyme Corporation of certain assets, including manufacturing technologies and other adeno-associated viral (AAV) vector technology, for up to $7 million in cash.

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