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Home » Newsletters » BioWorld

BioWorld

March 15, 2013

View Archived Issues

FDA's Draft Guidance Changes Game in Early Alzheimer's

Last month, the FDA's Center for Drug Evaluation and Research issued a draft guidance on the development of drugs in early stage Alzheimer's disease (AD). Intended as a conversation starter, the draft lays out a potential approach to select subjects with early AD and those at risk of developing the disease for enrollment into clinical trials. Read More

Simple, Cheap Method Could Improve Stem Cell Transplant

Scientists have discovered that nonsteroidal anti-inflammatory drugs (NSAIDs) can both mobilize blood-forming stem cells to leave the bone marrow and enter general circulation to be harvested for transplantation, and can engraft more easily when they are transplanted. Read More

Sinovac Jumps on Results for Hand, Foot and Mouth Vaccine

Sinovac Biotech Ltd.'s enterovirus 71 (EV71) vaccine looks good in preliminary results from Phase III data assessing efficacy, immunogenicity and safety against hand, foot and mouth disease (HFMD). Read More

Financings Roundup

• Hyperion Therapeutics Inc., of South San Francisco, completed its follow-on offering of about 2.8 million shares of common stock. In addition, the underwriters exercised their overallotment option in full and purchased an additional 431,250 shares of common stock. Read More

Other News To Note

• GenSpera Inc., of San Antonio, said the FDA granted orphan drug designation to G-202 for the treatment of hepatocellular carcinoma. Read More

Stock Movers

Read More

Clinic Roundup

• Oculus Innovative Sciences Inc., of Petaluma, Calif., completed a 112-day follow-up period in a trial of Microcyn Technology-based hydrogel for hypertrophic or keloid scars in 40 patients. Read More

Pharma: Other News To Note

• Astellas Pharma Inc., of Tokyo, said the European Commission approved expanded options for pre-treatment prior to use of Qutenza (8 percent capsaicin patch). Before application, the patient may now take an oral analgesic, or the treatment area may be pre-treated with a topical anesthetic. Read More

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