FDA

FDA’s CDRH sets goals for personalized medicine

Tuesday, January 24, 2012 02:51 PM

The FDA's Center for Devices and Radiological Health has set personalized medicine as one of its priorities for the current year, aiming for draft guidance on co-development of drugs and diagnostics by year's end.

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FDA includes social media in advertising guidance

Tuesday, January 24, 2012 02:45 PM

The FDA has issued a final guidance for industry product name placement, size and prominence in advertising and promotional labeling, including juxtaposition of proprietary and established product names.

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Eisai resubmits Perampanel NDA to FDA

Tuesday, December 27, 2011 01:28 PM

Eisai has resubmitted the New Drug Application (NDA) for the investigational AMPA-type glutamate receptor antagonist perampanel for partial-onset seizures associated with epilepsy to the FDA. This resubmission comes after the FDA issued a Refusal to File letter in July 2011 in which FDA requested reformatting and reanalyses of some datasets in the dossier. The application was originally submitted in May 2011.

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FDA reviews NDA for VIVUS' Qnexa

Tuesday, December 27, 2011 11:11 AM

VIVUS has reported that the Endocrinologic and Metabolic Drugs Advisory Committee of the FDA is scheduled to review the Company's New Drug Application (NDA) for Qnexa for the treatment of obesity on February 22, 2012. VIVUS resubmitted the NDA on seeking approval to market Qnexa in the United States. The FDA has accepted the NDA for review. The target date for the FDA to complete its review of the Qnexa NDA is April 17, 2012.

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FDA, ABIA collaborate on safety and performance of materials in medical devices

Thursday, December 22, 2011 11:05 AM

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Alexza retains Lazard, reduces workforce

Monday, December 19, 2011 01:53 PM

Alexza Pharmaceuticals has retained Lazard to assist in exploring strategic options to enhance stockholder value, including a possible sale or disposition of one or more corporate assets, a strategic business combination, partnership or other transactions.

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FDA proposes draft guidelines to address underrepresentation of women in clinical studies

Monday, December 19, 2011 12:11 PM

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Researchers look to disease-modifying therapy to ward off, possibly prevent Alzheimer’s disease

Monday, December 19, 2011 10:25 AM

Just as statins help lower high cholesterol levels to reduce the risk of heart attacks, researchers are seeking a comparable approach for people with large amounts of beta amyloid, an abnormal protein in the brain commonly found in Alzheimer’s disease patients. Medicines would clear those proteins before any signs of memory loss or other early symptoms of Alzheimer’s appear. 

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Soligenix, Harvard University partner to develop next generation anthrax vaccine

Thursday, December 15, 2011 04:15 PM

Soligenix, a development stage biopharmaceutical company, has initiated a next generation anthrax vaccine development program pursuant to a field-exclusive option agreement with Harvard University to negotiate a license under patent rights that cover prophylactic uses of a modified anthrax toxin protein. Initial development work will be covered pursuant to a previously issued $9.4 million National Institute of Allergy and Infectious Disease (NIAID) grant enabling development of thermo-stable ricin and anthrax vaccines.

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Covidien to launch spin-off pharmaceuticals business

Thursday, December 15, 2011 02:27 PM

Covidien, a global provider of healthcare products, plans to spin off its pharmaceuticals business into a standalone public company.

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