FDAnews Drug Daily Bulletin

The FDA is preparing to release a draft guidance that will contain details about a new investigational new drug (IND) application process that it hopes will enhance postdiscovery drug development, according to a top agency official.

An FDA advisory panel recently agreed not to recommend approval for Advanced Magnetics' Combidex, an investigational molecular imaging agent.

The American public is growing increasingly doubtful of the FDA's ability to ensure the safety of prescription drugs, according to a new national poll.

The FDA has issued a health advisory on AstraZeneca's Crestor, announcing that the cholesterol drug, like other statins, can have a rare side effect of serious muscle damage.

ImaRx Therapeutics, a biopharmaceutical company developing NanoInvasive therapies for stroke and cancer, has announced the placement of 2.3 million shares of common stock raising gross proceeds of $7 million.

Aspreva Pharmaceuticals Corp. has raised $113.3 million in its initial public offering. The Victoria-based drug developer said it has closed its offering of 8.28 million shares at a price of $13.68 per share.

Callisto Pharmaceuticals, a biopharmaceutical company focused on the development of drugs to treat cancer and osteolytic bone disease, announced the completion of a private placement of approximately 1.99 million shares of its common stock at a per share price of $1.52, for aggregate gross proceeds of approximately $3.02 million.

Barr Pharmaceuticals has confirmed that Kos Pharmaceuticals has filed a motion for a temporary restraining order and a preliminary injunction in the United States District Court for the Southern District of New York seeking to prevent Barr from launching generic versions of Kos' Niaspan 500-mg, 750-mg and 1,000-mg extended-release tablets (Niacin extended-release tablets) following final U.S. Food & Drug Administration (FDA) approval.

AXM Pharma announced that it entered into a distribution agreement with Sinopharm Holding Guangzhou for an expected purchase amount through December 2005 of RMB 54,000,000 (US$6,560,000) for the company's line of Elegance products, formerly known as Whisper.

Dutch biotechnology company Crucell N.V. and allied contract manufacturer DSM Biologics announced that they have signed a PER.C6 research license agreement with leading Japanese pharmaceutical company JCR Pharmaceuticals.

Alantos Pharmaceuticals Holding, a privately held biopharmaceutical company focused on the discovery and development of small molecule drugs with a focus on osteoarthritis/inflammation and Type II diabetes, announced it has raised $20 million in a series B private round of financing from existing investors Oxford Bioscience Partners, SV Life Sciences, Earlybird, ABN AMRO, Heidelberg Innovation and Ventech. Proceeds from the financing will be used to progress the company's pipeline of compounds, particularly its two lead candidates for diabetes and osteoarthritis into clinical development.

TASC Pharmaceuticals Ltd., a leading manufacturer of active pharmaceutical ingredients (API) and R&D service provider, said that it will merge with Glenmark Laboratories Ltd., a niche formulations and biopharmaceuticals player, in a deal valued at Rs12bn.