FDAnews Drug Daily Bulletin

The Centers for Medicare & Medicaid Services (CMS) performs only minimal oversight of drugmaker-reported best prices -- a practice that has resulted in taxpayers being overcharged for prescription drugs purchased through Medicaid, according to a new government report.

The nonpartisan Congressional Budget Office (CBO) has boosted its cost estimate for the Medicare prescription drug benefit, in part because the law's final rules allow drug plan sponsors to design more generous Rx formularies than had been expected.

The advances made in biotechnology R&D during the late 1980s and 1990s have significantly boosted the chances of biological therapeutics coming to market today, according to a drug development study.

Middle-age women can significantly reduce their risk of stroke by regularly taking low doses of aspirin, according to a new study that healthcare experts say will have major public health implications.

Wyeth Pharmaceuticals said it was served with a subpoena from the U.S. Attorney's Office in Massachusetts over pricing practices for its Protonix heartburn drug.

Abgenix announced that Genentech has exercised its option to extend its technology licensing agreement with Abgenix for an additional three years.

Mylan Pharmaceuticals is planning an expansion in southeast Greensboro that will add about 125,000 square feet to its existing space, nearly doubling its size.

Shareholders in Hoechst AG are trying to block Sanofi-Aventis SA's acquisition of the remaining shares it does not own in the company, a spokesman for Sanofi-Aventis said.

MDS and Atomic Energy of Canada Limited (AECL) announced that the two companies have reached an agreement to seek a mediated resolution of the issues related to the construction, commissioning and operation of the MAPLE facilities in Chalk River, Ontario.

The law firm of Schatz & Nobel, which has significant experience representing investors in prosecuting claims of securities fraud, announces that a lawsuit seeking class action status has been filed in the United States District Court for the Western District of Washington on behalf of all persons who purchased the publicly traded securities of Cell Therapeutics between June 7, 2004, and March 4, 2005, inclusive.

Enanta Pharmaceuticals has received a milestone payment from its EP-013420 East Asia development and commercialization partner, Shionogi & Co. Ltd.

Endo Pharmaceuticals Holdings licensed Durect's pain patch for an upfront fee of $10 million, and said it lowered its 2005 adjusted earnings guidance to reflect higher research and development costs.