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Home » Newsletters » BioWorld

BioWorld

March 7, 2011

View Archived Issues

New Labeling May Signal Trouble for Vivus' Qnexa

WASHINGTON – The FDA's call for more explicit labeling about birth defects for topiramate is not the news Vivus Inc. wanted to hear. Read More

BioSante Offering to Support Female Sex Dysfunction Drug

BioSante Pharmaceuticals Inc. said it will raise $25.1 million in a registered direct offering to support several ongoing clinical trials of its testosterone gel product, Libigel. Pursuant to a prior shelf registration, the Lincolnshire, Ill.-based company will sell 12.2 million shares of common stock and warrants to several institutional investors, with total net proceeds estimated at $23.8 million. Read More

Yet Another Immune System Role in Brain Development

Yet another link between the brain and the immune system – a connection that was once thought to be nonexistent – was reported recently with findings that major histocompatibility complex (MHC) molecules play a role in shaping neural connections in early brain development. Read More

NewCo News: Arsanis' Founders Convince Forward-Looking 'A' Investors

We know all too well that forward-looking statements involve significant risks and uncertainties, no forward-looking statement can be guaranteed and actual results may differ materially from those projected. Read More

Clinic Roundup

Depomed Inc., of Menlo Park, Calif., completed enrollment in its Phase III trial, designated Breeze 3, testing Serada (extended-release gabapentin tablets) as a nonhormonal treatment of menopausal hot flashes. The study, which recruited about 600 patients, is testing reductions in the mean frequency of moderate to severe hot flashes and the average severity of hot flashes measured after four and 12 weeks of stable treatment as the co-primary endpoints. The treatment duration will be 24 weeks to address FDA requirements. Breeze 3 is being conducted under a special protocol assessment. Read More

Stock Movers

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Appointments and Advancements

Genesis Biopharma Inc., of Los Angeles, named Anthony J. Cataldo president and CEO. It also added Michael Handelman as chief financial officer, treasurer and secretary. Read More

Other News To Note

MediciNova Inc., of San Diego, and Zhejiang Medicine Co. Ltd., of Hangzhou, China, signed a letter of intent to form a joint venture to develop and commercialize MediciNova's MN-221 in China. Financial terms were not disclosed. MN-221, a selective, beta2-adrenergic receptor agonist, is in development in acute exacerbations of asthma and chronic obstructive pulmonary disease. Read More

Bench Press

Researchers from Children's Hospital Boston have identified a new protein that regulates skin stem cells, and could be a target for the control of wound healing on the one hand, and skin cancer on the other. Read More

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