In response to a U.S. shortage of a vaccine to protect infants from Haemophilus influenzae type b (Hib), GlaxoSmithKline (NYSE: GSK) has received accelerated approval from the FDA (Food and Drug Administration) for Hiberix((R)) [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)] as a booster dose in children 15 months through four years of age. Hib is an often severe and potentially deadly bacterial infection that can cause meningitis. [More]

"A bitter Congressional fight over the cost of superexpensive biotechnology drugs has come down to a single, hotly debated number: How many years should makers of those drugs be exempt from generic competition?" The New York Times reports. [More]

"A veteran California lawmaker with ties to the biotechnology industry said she thinks her proposal to protect brand-name biologic makers has enough support to carry in the House Energy and Commerce Committee," Dow Jones Newswires/Wall Street Journal reports. [More]

"Senators agreed Monday to give high-tech biologic drugs 12 years of market protection before generic versions can compete," according to The Associated Press. [More]

White House officials said Thursday that biotech drugs (also known as biologics) should only be protected from generics competition for seven years, Reuters reports. [More]

Roche has announced that it has submitted a combined filing to the European health authorities (the European Medicines Agency) for three new indications to extend the label for MabThera to use as a first-line biologic therapy for patients with rheumatoid arthritis (RA). [More]

"A draft proposal in the Senate to overhaul the nation's health-care system would require most people to buy health insurance, authorize an expansion of Medicaid coverage and create consumer-owned cooperative plans instead of the government coverage that President Obama is seeking," the Washington Post reports. [More]

Federal officials are expected to offer recommendations this month on one of the first installments of health reform - a new initiative to compare the value and merits of competing medical treatments. [More]

Senate Democrats are scrambling to reduce the price tag of reform proposals, which initial estimates place at $1.6 trillion, The Wall Street Journal reports. [More]

Jeffrey M. Friedman, Marilyn M. Simpson Professor and head of the Laboratory of Molecular Genetics at Rockefeller University, has received the 2009 Shaw Prize in Life Science and Medicine. The prize was announced today by the Hong Kong-based Shaw Prize Foundation. [More]

Researchers at Nationwide Children's Hospital and Johns Hopkins University have discovered that delivering a small molecule that is highly expressed in normal tissues but lost in diseased cells can result in tumor suppression. [More]

Sen. Chris Dodd, D-Conn., said Tuesday morning that the most contentious issues in health care reform such as a public plan and employer mandate will be left out of a bill for now, Politico reports. [More]

Medtronic, Inc. has announced results from a Federal Circuit Court review of a December 2007 patent infringement verdict regarding the Vertex line of multiaxial screws, which are no longer on the market. [More]

Biologic disease-modifying antirheumatic drugs (DMARDs) such as adalimumab, etanercept and infliximab are effective at reducing symptoms and slowing progression of rheumatoid arthritis (RA). These drugs act more quickly, require less laboratory monitoring, and are better tolerated than nonbiologic DMARDs, but they are also up to 100 times more expensive. [More]

Bioniche Life Sciences Inc. has provided an update on its Phase III clinical program evaluating Urocidin(TM) in the treatment of bladder cancer. On March 31st, the Company announced that recruitment had been completed in its initial Phase III registration trial evaluating Urocidin in the treatment of non-muscle-invasive bladder cancer that is refractory (unresponsive) to the current standard immunotherapy - Bacillus Calmette-Guérin (BCG). [More]