FDA

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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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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