FDAnews Drug Daily Bulletin

The growing use of IT in the healthcare system -- including through electronic prescribing and electronic medical records -- could significantly boost the FDA's ability to monitor drug safety, according to a top agency official.

Despite strong protests from the generics industry and some lawmakers, brand firms' use of authorized generics to extend the profitability of drugs coming off patent is a trend that will continue to grow, according to a new research report.

Generic painkiller hydrocodone (with APAP) was the most frequently prescribed drug in the U.S. last year -- one of six generic drugs to crack NDCHealth's top 10 list of pharmaceutical products.

Pharmaceutical firms have yet to fully understand the implications of the Medicare Rx drug benefit, say experts who urge drugmakers to develop compliance strategies around the new regulations requiring the disclosure of drug pricing.

Biopharmaceutical company Repligen Corp. and Stanley Medical Research Institute entered a development agreement that gives Repligen funding for a Phase I clinical trial for a treatment of bipolar disorder, the company announced.

Icagen, Inc. announced that it has received a milestone payment from Yamanouchi Pharmaceutical Co., Ltd. related to the selection of a compound for advanced preclinical studies as a result of the collaboration between the two companies in dementia, including Alzheimer's disease.

Peregrine Pharmaceuticals, Inc., a biopharmaceutical company with a broad portfolio of products under development, announced financial results for the third quarter ended Jan. 31, 2005.

Amazon Biotech, a developer and producer of AMZ 0026, a potential immunomodulator drug developed for use in the treatment of the HIV virus, announced that it has raised a total of $618,500 in gross proceeds in equity capital private placements since February 2004.

ViaCell, Inc. and Genzyme Corporation announced that the two companies entered into a collaboration related to diabetes.

Titan Pharmaceuticals Inc. said it lost $7.8 million in the fourth quarter ended December, compared with a loss of $10.5 million in the same quarter a year ago.

The board of drugmaker GlaxoSmithKline Pharmaceuticals told the BSE on Tuesday that it had approved a buyback of shares at up to Rs 800 per share.

Seattle Genetics, Inc. announced that it has achieved a milestone under its antibody-drug conjugate (ADC) collaboration agreement with Genentech, triggering an undisclosed payment to Seattle Genetics.