The FDA's prescription drug promotion arm wrote that the professional print ad for seizure med Aptiom "misleadingly overstated its efficacy."
The much hashed-over initiative would require pharma firms to distribute the professional insert electronically.
Judge rules Actavis must keep Alzheimer's drug on the market; Wyeth CEO joins Roche board, dispelling rumors he may be next Sanofi CEO; Two senators propose new FDA designation which would award 15 years of marketing exclusivity.
GSK opts to hold onto $1.6 billion portfolio of older drugs; Sanofi upheavals continue with exit of US diabetes sales exec; Takeda gains breakthrough status on AL amyloidosis therapy.
Jakafi becomes the first drug approved for treating polycythemia vera.
Despite drugmaker discount, VA still can't afford Sovaldi without additional funds; Ousted Sanofi CEO Viehbacher faces lawsuit for an alleged kickback scheme; GSK slims sales and R&D workforce.
Amgen's Blincyto was approved for a rare form of leukemia after receiving Breakthrough Therapy designation and a Priority Review.
An Italian court backs the anti-trust's stand that Novartis and Roche colluded in Lucentis marketing; AstraZeneca is the test case for the court's new interpretation of pay-for-delay; early-stage results prompt Biogen Idec to take its experimental Alzheimer's treatment to Phase-III.
I come not to bury government but to praise it—at least the singular agency I know best: FDA
FDA issued a complete response letter on daclatasvir.
Does a health psychology approach hold the key to Rx adherence? In MM&M's latest Leadership Exchange Uncut eBook, industry stakeholders from the payer, provider, academic and pharma realms explore the "why" behind medicine taking. Access here.