FDAnews Drug Daily Bulletin

The FDA has released a draft guidance providing recommendations on nonclinical safety evaluations to support the clinical study and approval of drug combinations, including fixed-dose combination products, co-packaged products and adjunctive therapies.

FDA drug safety reviewers should have a new data-mining tool this spring to help them evaluate the hundreds of thousands of reports submitted annually to the Adverse Events Reporting System (AERS) -- a system that is now more widely available to the public online.

Merck's arthritis pain drug Vioxx might have caused as many as 140,000 cases of serious coronary heart disease in the U.S. since its launch in 1999, according to a study published by the British medical journal The Lancet.

The September 2004 recall of pain reliever Vioxx took a heavy toll on Merck's fourth quarter earnings, which plummeted by more than 20 percent as a result of the action.

Covalent Group, which completes clinical R&D, has said it was awarded $2.7 million of new contracts.

India's parliament will shortly ratify new legislation protecting drug patents, paving the way for the country to become a major pharmaceutical research center, its trade minister said.

Rigel Pharmaceuticals and Pfizer have entered into a collaborative research and license agreement for the development of inhaled products to treat allergic asthma and other respiratory diseases.

Tanabe Seiyaku has signed an addendum to its licensing agreement with Centocor of Pennsylvania for Remicade, an anti-TNF-alpha monoclonal antibody preparation developed by Centocor.

ESP Pharma, a niche pharmaceutical company focused on the acquisition, marketing and late-stage development of life-saving acute-care therapeutics, has announced the acquisition, by ESP Pharma, of U.S. and Canadian rights to Retavase (reteplase) from Centocor, a biopharmaceutical operating company of Johnson & Johnson.

XOMA intends, subject to market and other conditions, to sell approximately $60 million principal amount of its Convertible Senior Notes due 2012 to qualified institutional buyers pursuant to Section 4(2) and Rule 144A under the Securities Act of 1933, as amended.

Wyeth Pharmaceuticals, a division of Wyeth, is adding 52 drug development positions to open a second drug development line at its Wyeth BioPharma Campus in Andover.

CepTor is a biopharmaceutical company focused on the development of cell-targeted therapeutic products for neuromuscular and neurodegenerative diseases.

Curis, a therapeutic drug development company, has elected to exercise a co-development option with its collaborative partner, Genentech, and will now share in U.S.