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 – 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.
Despite congressional mandates placing price outside the realm of drug approvals, the U.S. is far from immune to the pricing pressures dominating Europe's approval process.
Although members of the FDA's Oncologic Drugs Advisory Committee (ODAC) were admittedly underwhelmed Wednesday by the data for Talon Therapeutics Inc.'s Marqibo, they voted 7 to 4, with two abstentions, that the drug demonstrated a favorable risk-benefit profile as a third-line treatment for adults with Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL).
While other drugmakers are spending billions of dollars in pursuit of the next-generation hepatitis C treatment, Okairos AG is on a quest for the holy grail – a preventive hepatitis C virus (HCV) vaccine.
