Chattem's Allegra launch

With FDA over-the-counter approval inhand, Chattanooga-based Chattem (Sanofi-Aventis) prepares to launch its Allegra product. The TFP reports.

FDA industry basics website

The U.S. Food and Drug Administration has launched an FAQ site for industry seeking FDA approvals.

Not easy some days being Cumberland Pharma

Cumberland Pharmaceuticals, the Nashville-based company that IPO'd 16 months ago, today announced an adverse FDA response to its requested sNDA. CP says it plans to seek a meeting. The news follows discord among some of the stock's analysts.

FDA scrutiny of new Med devices

The New York Times reports the FDA is being challenged to strengthen its review of clinical-trials data for efficacy and danger of new medical devices, following allegations of inadequate rigor in reviewing trials.

BioMimetic trial results in

BioMimetic Therapeutics Inc. announced yesterday impressive data from randomized trials of its Augment Bone Graft product, showing it performed well in comparison with material harvested via autograft. The release is here. At 4:20 p.m. CT today, the stock was up about 20 percent over day-earlier.

Diatherix H1N1 test greenlighted

DIATHERIX Laboratories, based in Huntsville, with offices in Middle Tennessee, announced it has been granted emergency use authorization by the FDA for its DIATHERIX H1N1-09 Influenza Test.

e-Cig developer sets August U.S. launch

Smokefree Innotec said July 31 it will launch in target U.S. markets this month. The Nashville-based company issued a press release Wednesday, saying recent FDA criticism of e-cigs did not include their product. VNC's earlier story on Smokefree.

Biomimetic gets SEC nod for offering

Local BioMimetic Therapeutics (NASDAQ: BMTI) announced today, following-up on its earlier announced intentions, that "the Securities and Exchange Commission (the “SEC”) has declared effective the Registration Statement on Form S-3 filed by the Company in connection with the rights offering previously announced by the Company. Accordingly, the Company has launched the $17 million rights offering pursuant to which holders of its common stock, except with respect to shares of common stock held by the BioMimetic 401K Plan, will be entitled to purchase additional shares of its common stock at a price of $8.50 per share. The proceeds from the rights offering are expected to be used for general corporate purposes, including to fund additional product development and potential commercialization activities."