FDA

Amicus to relaunch phase II

Wednesday, March 9, 2011 10:38 AM

Amicus Therapeutics is planning a new phase II study of its experimental therapy for Pompe disease, AT2220, now that the FDA has decided to lift a clinical hold on the program. The Cranbury, N.J.-based biotech says it expects to have phase II data available before the end of 2011.

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Nycomed/Forest drug gains FDA approval

Tuesday, March 8, 2011 10:45 AM

The FDA has approved Nycomed and partner Forest Laboratories’ chronic obstructive pulmonary disease drug roflumilast, according to PharmaTimes.

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Merck fails to win FDA support

Tuesday, March 8, 2011 10:43 AM

Merck, based in Darmstadt, Germany, failed to win FDA support for its multiple sclerosis pill cladribine.

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ImmunoGen touts new drug-delivering antibodies

Tuesday, March 8, 2011 10:33 AM

After forming partnerships with several major pharmaceutical companies, Waltham, Mass.-based biotech ImmunoGen wants to boost its pipeline of antibody-drug conjugates.

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Salix says FDA won't approve Xifaxan for irritable bowel syndrome

Tuesday, March 1, 2011 08:45 AM

Salix Pharmaceuticals, a maker of drugs for gastrointestinal disorders, said U.S. regulators won’t approve its Xifaxan for a form of irritable bowel syndrome, Bloomberg News reported.

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BioSante completes study enrollment

Tuesday, March 1, 2011 08:40 AM

BioSante Pharmaceuticals has completed enrollment of subjects in the first of two pivotal phase III LibiGel (testosterone gel) safety and efficacy trials, being conducted under an FDA-approved special protocol assessment (SPA) agreement.

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FDA issues complete response to Protalix

Tuesday, March 1, 2011 08:33 AM

The FDA has issued a complete response letter for Protalix's Gaucher's disease drug taliglucerase alfa. Protalix won't be required to conduct any additional clinical studies, but that didn't stop its stock from plunging on the news, FierceBiotech reported.

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NicOx to appeal FDA rejection

Tuesday, March 1, 2011 08:30 AM

French biotech NicOx said last week it plans to appeal the FDA’s decision to turn down its anti-inflammatory drug naproxcinod for marketing approval, Reuters reported. NicOx made the announcement at its 2010 earnings presentation.

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FDA issues warning letter to Sanofi-aventis

Tuesday, March 1, 2011 08:00 AM

The FDA has warned Sanofi-Aventis’ U.S. unit for failing to submit reports of possible serious drug side effects in a timely manner. In a Jan. 28 letter made public last week, the FDA said an early response from the drugmaker and its "promised corrective actions are inadequate to address the deficiencies."

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Caraco Pharma to merge with majority owner Sun

Tuesday, March 1, 2011 08:00 AM

Detroit-based Caraco Pharmaceutical Laboratorieshas agreed to merge with majority owner Sun Pharmaceutical Industries andSun Pharma Global, according to Crain’s Detroit Business.

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