Big pharma is refusing to go quietly into the night as its biggest blockbusters fall off the patent cliff, endangering more than half of some drugmakers' brand portfolios.

WASHINGTON – The Supreme Court is being asked to curb a growing cottage industry of shareholder lawsuits by raising the bar for class actions alleging companies have frauded the market.

WASINGTON – Despite warnings against weighing down the PDUFA and other user fee agreements negotiated between the FDA and industry, Congress is piling on the calories with favorite menu items ranging from drug shortage notification to social media guidance.

WASHINGTON – With more riding on the reauthorization of PDUFA than ever before, a Senate committee is pushing through a package of user fees with a warning against bogging it down with costly and controversial measures.

Cardiovascular safety won out over all other risk factors and the need to encourage the development of innovative weight-loss drugs Thursday as the FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 17-6 that cardiovascular outcome trials (CVOTs) should be required for all obesity drugs, even those that have no theoretic cardiovascular risk or signal.

Members of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) got a lot to chew on Wednesday as they considered how to assess cardiovascular risks when developing drugs to treat obesity.

WASHINGTON – It's about to be a whole new ballgame for small biotechs looking to go public.

WASHINGTON – Leaving a lot of personalized medicine claims in patent limbo, the Supreme Court Monday told an appellate court to reconsider a challenge to Myriad Genetics Inc.'s claims on the BRCA1 and BRCA2 genes, used in diagnostics for breast and ovarian cancer.

WASHINGTON – A new capital formation environment for small biotechs on their way to going public could be just days away, if the House agrees to the Senate's investor protections for crowd funding.