FDA posted a revised draft guidance document on its brief summary and adequate directions for use concerning risk information in DTC print ads to reflect "recent social science research."
FDA has named Kathleen Uhl as permanent director of the Office of Generic Drugs.
Sandoz received FDA biosimilar nod; new technique yields 25 antibiotics; Novartis sends two COPD drugs for FDA review.
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.
The agency sent a Warning Letter to three marketers over their use of metatags in search engine marketing tactics.
An advisory panel voted against adding warnings to steroid injection labels.
AstraZeneca and Ranbaxy pay-for-delay case marches on; FDA extends Novartis multiple myeloma Priority Review timeline; Endo pays $25 for testosterone nasal gel.
The Center for Drug Evaluation and Research's director says there is a need for new opioids and cuts off dosing comparisons between extended-release and immediate-release opioids.
The reason: coordination and effectiveness.
The north-of-the-border solution comes amid climbing heroin abuse in the US.
BioMarin to acquire Dutch biotech Prosensa; Woodcock says significant efficacy key to Breakthrough Therapy designation; Stryker considers $16 billion bid for UK devicemaker Smith and Nephew.
EMA revises its conflict of interest policy; AbbVie all-oral HCV combo drug receives positive EU recommendation; Merck may help NewLink Genetics scale production of its Ebola vaccine.
The first approved hydrocodone formulated to discourage misuse raises a challenge to controversial Zohydro.
CRS asks if high prices are a tool to offset CMS rebates, the FDA adds another DTC study to its lineup, and the NIH proposes making more clinical trial data public.
As generic drug use soars, the agency intends to "create parity" in label-change rules for brands and generics.
A US Senate bill would also make treatments for the disease eligible for priority review vouchers.
The drugmaker is offering Scotland's NHS a money-back guarantee for Olysio patients.
Salix-Cosmo tax-inversion deal quashed, chronic heart failure market set to expand, rising generic drug prices get lawmakers' attention, NICE gives leukemia drug a thumbs-down, FDA has a good rep
The designation is for diabetic retinopathy for patients with diabetic macular edema.
NY's attorney general alleges that a formulation switch is an attempt to create monopoly.
The FTC is suing AbbVie and two other firms in a pay-for-delay case that could have wider implications for pharma
Bloomberg reports that India's Wockhardt has become an M&A target.
The FDA froze the clinical trial of anti-Fzd7 vantictumab in July over concern about "bone-related adverse events."
The FDA has approved Arnuity Ellipta for asthma.
Inspectors of Marck Biosciences found an array of problems during a October-November 2013 inspection, including mold near a sterile area that was so bad "the room had 'partially caved in.'"
A host of doctors has asked FDA Commissioner Margaret Hamburg to back a naming convention that would require biologics and biosimilars to have different names.
Despite a collaboration with original Sovaldi owner Pharmasset in 2004, a panel ruled Roche has no rights to HCV treatment Sovaldi.
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