FDA

Merck pulls out of Portola collaboration

Tuesday, March 29, 2011 12:49 PM

Merck has returned global rights for the investigational clotbuster betrixaban to California-based Portola Pharmaceuticals, according to PharmaTimes.

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Savient signs agreement with U.S. Dept. of Veterans Affairs

Tuesday, March 29, 2011 11:56 AM

New Jersey-based Savient Pharmaceuticals signed a deal to supply the U.S. Department of Veterans Affairs with Krystexxa, its new gout drug, along with its weight-gain medication, Oxandrin, for five years, according to Fierce Pharma.

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ARX, InnovoCommerce partner

Tuesday, March 29, 2011 11:37 AM

ARX, a provider of digital signature solutions, has partnered with InnovoCommerce, an independent software vendor.

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Drugmakers may face FDA fines for slow efficacy confirmation in cancer drugs

Monday, March 28, 2011 01:04 PM

Winning early U.S. approval of promising cancer treatments could wind up costing drugmakers up to $10 million in fines if they don’t confirm their drugs’ effectiveness in follow-up studies within a restrictive timeframe, FDA officials said, according to a Bloomberg report.

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FDA requires sponsors to inform study volunteers that clinical trial information will be posted online

Monday, March 28, 2011 08:05 AM

The FDA has issued a final rule requiring drug developers to include in informed consent paperwork the disclosure that clinical information from the trial will be entered onto ClinicalTrials.gov.

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Oramed completes toxicity trial for ORMD-0801

Thursday, March 24, 2011 12:33 PM

Oramed Pharmaceuticals, a developer of oral delivery systems, successfully completed a comprehensive toxicity study for its flagship oral insulin capsule, ORMD-0801. The study was completed under conditions prescribed by the FDA’s Good Laboratory Practices regulations and is the last study required before an IND filing.

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Many trials exclude depressed patients

Tuesday, March 22, 2011 11:20 AM

When the FDA announced in 2009 that Pfizer’s smoking-cessation drug Chantix would need to carry a restrictive "black box" warning label, the move didn't really surprise the market, according to a Reuters report.

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FDA approves Bayer's Gadavist injection for MRI

Friday, March 18, 2011 10:32 AM

Bayer HealthCare Pharmaceuticals said the FDA has approved Gadavist (gadobutrol) injection, a macrocyclic gadolinium-based contrast agent (GBCA), for intravenous use in diagnostic magnetic resonance imaging (MRI) in adults and children (2 years and older) to detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system (CNS).

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Omthera Pharmaceuticals begins phase III EVOLVE trial

Thursday, March 17, 2011 12:46 PM

Omthera Pharmaceuticals, a privately-held New Jersey-based specialty pharmaceuticals company, said the first patient has been dosed in its pivotal phase III EVOLVE (EpanoVa fOr Lowering Very high triglyceridEs) trial for Epanova, the company's lead compound for the treatment of patients with very high triglycerides. Epanova is an Omega-3 fatty acid containing a novel formulation of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).  The phase III trial was granted a Special Protocol Assessment (SPA) from the FDA.

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FDA grants 510K clearance to Life Technologies

Thursday, March 17, 2011 12:04 PM

Life Technologies said it has received FDA 510K clearance for StemProR MSC SFM—a first for this next-generation stem cell culture medium that is now cleared as a medical device and satisfies a crucial requirement for researchers involved in clinical trials in the U.S.

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