FDA

Genetics remains at top of academic research

Friday, March 11, 2011 01:51 PM

Genetics is still the hottest area of scientific research, a decade since the mapping of the human genome, despite slow progress in translating discoveries into new medical treatments, according to a report in Reuters.

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FDA approves generic Taxotere

Friday, March 11, 2011 01:47 PM

Hospira has won approval for the first U.S. generic version of Sanofi-aventis’ Taxotere cancer drug, according to a Reuters report.

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ARYx Therapeutics to close

Friday, March 11, 2011 01:41 PM

ARYx Therapeutics said it will wind down its operations due to lack of funding after the FDA delayed providing guidance on the trial design of its experimental drug for gastrointestinal disorders, according to Reuters.

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Talecris Biotherapeutics receives EU orphan drug designation for Plasmin

Friday, March 11, 2011 11:56 AM

Talecris Biotherapeutics has been granted orphan drug designation by the European Commission for the development of Plasmin (human) to treat acute peripheral arterial occlusion (aPAO). Talecris is currently investigating Plasmin in a phase II clinical trial designed to assess its ability to treat aPAO, a condition in which arterial blood flow to the extremities, usually the legs, is blocked by a clot. 

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Teva: Doctors being contacted for trial of Copaxone copy

Wednesday, March 9, 2011 01:34 PM

Doctors are being contacted to organize a clinical trial for a copy of Teva Pharmaceutical’s multiple sclerosis medicine Copaxone, according to a report in FiercePharma.

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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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