FDAnews Drug Daily Bulletin

Widespread use of electronic data capture (EDC) technology is helping Novartis Pharmaceuticals cut down on errors during the clinical trial process and achieve research savings approaching $100 million annually.

The safety and efficacy of Chiron's immunosuppressant candidate Pulminiq will be reviewed by the FDA's Pulmonary-Allergy Drugs Advisory Committee in a June meeting.

The pharmaceutical supply chain involves multiple organizations playing sometimes overlapping roles in product distribution and contracting, but drugmakers clearly have the most influence in establishing prices, according to a new report that explains the multistep path a drug takes from manufacturer to patient.

Describing the current treatments for systemic lupus erythematosus (SLE) as inadequate, a new FDA document aims to help industry develop new treatments for the immune system disease.

Drugmaker aaipharma said on Monday it is highly likely that it will seek Chapter 11 bankruptcy protection, after failing to make interest payments on some corporate debt on April 1.

Manhattan Pharmaceuticals has acquired Tarpan Therapeutics, a privately held, New York-based pharmaceutical company, in an all stock transaction that resulted in Tarpan shareholders owning approximately 20% of the shares of Manhattan on a fully-diluted basis.

Abbott Laboratories and Geneva Pharmaceuticals have agreed to a $30.7 million nationwide settlement to refund customers and third-party payers in 18 states who claimed that the two companies had conspired to engage in anticompetitive conduct selling a drug that treats hypertension and enlarged prostate.

Curis, a therapeutic drug development company, today announced that it has established a second major collaboration with Genentech.

Cellegy Pharmaceuticals said Tuesday its accountants will include a going concern qualification in its annual 10-K financial report, and that it will seek to raise money through partnership with other drug companies or through equity or debt financing.

Inncardio, a company founded by Bioaccelerate Holdings, announced today a definitive agreement to acquire Cengent Therapeutics Inc., a privately held, structure-guided drug discovery company based in San Diego, CA. Inncardio is a biotechnology company focused on the development of treatments and therapies targeted at cardiovascular-related diseases.

Biovail Corporation announced today that a United States District Judge for the District of Columbia has granted Biovail's motions for summary judgment, thereby dismissing complaints in two related putative class-action cases asserting antitrust claims by purchasers of Biovail's Tiazac product.

Sigma-Aldrich Corporation announced today that it has completed its acquisition of the Proligo Group (Proligo) from Degussa AG (Frankfurt: DGXG.DE).