Legal/Regulatory

OPDP slams print ad in untitled Warning Letter

OPDP slams print ad in untitled Warning Letter

The FDA's prescription drug promotion arm wrote that the professional print ad for seizure med Aptiom "misleadingly overstated its efficacy."

FDA issues long-awaited plan for electronic labeling

The much hashed-over initiative would require pharma firms to distribute the professional insert electronically.

Five things for pharma marketers to know: Friday, December 12

Five things for pharma marketers to know: Friday, December 12

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.

Five things for pharma marketers to know: Friday, December 5

Five things for pharma marketers to know: Friday, December 5

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.

Incyte drug gains expanded indication for bone marrow disease

Jakafi becomes the first drug approved for treating polycythemia vera.

Five for things pharma marketers to know: Thursday, December 4

Five for things pharma marketers to know: Thursday, December 4

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.

FDA approves Amgen leukemia immunotherapy

Amgen's Blincyto was approved for a rare form of leukemia after receiving Breakthrough Therapy designation and a Priority Review.

Five things for pharma marketers to know: Wednesday, December 3

Five things for pharma marketers to know: Wednesday, December 3

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.

Washington Insider - Dec 2014

Washington Insider - Dec 2014

I come not to bury government but to praise it—at least the singular agency I know best: FDA

BMS proposed HCV therapy gets cold shoulder from regulators

BMS proposed HCV therapy gets cold shoulder from regulators

FDA issued a complete response letter on daclatasvir.


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