WASHINGTON – Although the FDA's vision is bigger than its budget, the agency is guardedly optimistic that it can avoid painful cuts next year. Read More
AMRI continues its work with the Institute of Neurological Disorders and Stroke (NINDS) with a potential $43 million drug discovery contract in the area of neurological and degenerative diseases. Read More
The Internal Revenue Service (IRS) has issued temporary regulations for imposing billions of dollars of branded prescription drug fees on drugmakers under the Patient Protection and Affordable Care Act, but it was not immediately clear whether the complex rules resolved earlier industry concerns that included the data and process used to calculate fees for individual companies. Read More
Cytokinetics Inc., of South San Francisco, said The Lancet published results from two studies supporting the use of omecamtiv mecarbil in heart failure. Read More
BioTime Inc., of Alameda, Calif., said four of its human embryonic stem cell lines will be included in the National Institutes of Health Human Embryonic Stem Cell Registry and can be used for federally funded research. Read More
Researchers from Lund University developed a protein signature that can predict, with improved accuracy over current methods, the risk breast cancer patients have of developing metastases. Read More
The picture isn't pretty: Stocks are down, unemployment is up and Standard & Poor's lowered its long-term sovereign credit rating on the U.S. to AA+ from AAA. Other downgrades followed, including Berkshire Hathaway and a slew of municipal bonds. Consumer spending dropped in June for the first time in about two years, prompting macroeconomists to lower their GDP estimates. Read More
Proving it can indeed beat deadlines when it wants to, the FDA issued a surprise approval of Seattle Genetics Inc.'s Adcetris (brentuximab vedotin) for two kinds of lymphoma late Friday afternoon – more than a week ahead of the Aug. 30 PDUFA date. Read More
