FDA

PhRMA issues statement on biosimilar user fees

Thursday, December 8, 2011 10:20 AM

Pharmaceutical Research and Manufacturers of America (PhRMA) vice president Sascha Haverfield-Gross has issued the following statement about user fees for biosimilars:

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HighQ partners with SAFE-BioPharma

Wednesday, December 7, 2011 12:23 PM

London-based HighQ has formed a vendor partnership with the SAFE-BioPharma Association. Companies within the global pharmaceutical and biotechnology industry use the SAFE-BioPharma standard in FDA Title 21 CFR part 11 compliant processes for signing SOPs, quality and compliance documentation, research and development documentation, corporate compliance documents and more.

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Curemark's phase III autism trial shows positive results

Wednesday, December 7, 2011 10:08 AM

Curemark has reported its phase III double blind randomized placebo controlled multicenter clinical trial of CM-AT for autism met its primary and secondary endpoints. The trial compared CM-AT to placebo in children with autism aged 3-8. Top line results demonstrate a statistically significant effect of CM-AT over placebo on both core and non-core symptoms of autism.

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NASA signs patent license agreement for Atherosclerosis treatment

Monday, December 5, 2011 12:05 PM

NASA has signed a patent license agreement that will allow a California company use of NASA-developed technology that could be used to treat hardened arteries in the heart.

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Schulman Associates IRB acquires Independent IRB

Monday, December 5, 2011 11:18 AM

Schulman Associates Institutional Review Board has acquired Independent
Investigational Review Board. The transaction allows both organizations, which protect the rights of human research subjects, to provide a more comprehensive suite of review services for pharmaceutical, medical device, contract research organization and clinical research site customers.

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FDA issues draft guidance on medical devices, launching pilot program with nine companies

Monday, December 5, 2011 09:15 AM

The FDA has issued two draft guidance documents that focus on early-stage development of medical devices. 

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FDA issues draft guidance for artificial pancreas device systems

Friday, December 2, 2011 04:32 PM

The FDA has issued draft guidance designed to help investigators and manufacturers as they develop and seek approval for artificial pancreas device systems to treat type 1 diabetes.

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ADVENTRX meets with FDA to review ANX-188

Friday, December 2, 2011 04:23 PM

ADVENTRX Pharmaceuticals met with the FDA to review development plans for ANX-188 (purified poloxamer 188), the company's first-in-class treatment for sickle cell patients experiencing vaso-occlusive crisis.

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Nearly 90 medicines and vaccines in development for HIV/AIDS

Friday, December 2, 2011 03:51 PM

America’s biopharmaceutical research companies are testing 88 medicines and vaccines to treat or prevent HIV/AIDS and related conditions, according to a report by the Pharmaceutical Research and Manufacturers of America (PhRMA).

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FDA approves first generic version of Lipitor

Thursday, December 1, 2011 12:17 PM

The FDA has approved the first generic version of the cholesterol-lowering drug Lipitor.

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