FDA

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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Pfizer to gradually move antibacterials operations to China

Wednesday, March 16, 2011 01:00 PM

Pfizer plans to move its antibacterials research unit in Groton, Conn., to Shanghai, China, but said some local scientists involved in the research will remain in Groton for up to two years as the company builds the new Shanghai unit, according to a report in Connecticut newspaper The Day.

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Dendreon’s CSO, Dave Urdal, to retire

Tuesday, March 15, 2011 01:43 PM

David Urdal, the scientific entrepreneur who co-founded Dendreon 15 years ago and helped turn it into a pioneer of cancer immunotherapy, is stepping down from his job as chief scientific officer at the Seattle biotech company, according to Xconomy Seattle.

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Adamis looks to test prostate cancer drug on humans

Monday, March 14, 2011 01:48 PM

Adamis Pharmaceuticals is seeking permission from federal regulators to begin testing APC-100, an experimental prostate cancer drug, on human patients for the first time, according to the San Diego Union-Tribune.

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Lilly CEO confident in FDA approval

Monday, March 14, 2011 01:31 PM

Eli Lilly CEO John Lechleiter said he's confident of gaining U.S. regulatory approval for a drug to help identify plaque in the brain associated with Alzheimer's disease, according to a Bloomberg News report.

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Report: Big Pharmas embracing technology as they transform to ‘holistic healthcare entities’

Monday, March 14, 2011 07:00 AM

Pharmaceutical companies—having outsourced R&D functions to CROs and collaborated with biotechs, drug companies and academic groups for innovative products and platforms—are now embracing a different type of innovation: technology.

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