Legal/Regulatory

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.

FDA panel recommends against steroid injection warning

An advisory panel voted against adding warnings to steroid injection labels.

FDA takes issue with metatags

The agency sent a Warning Letter to three marketers over their use of metatags in search engine marketing tactics.

Five things for pharma marketers to know: Tuesday, November 25

Five things for pharma marketers to know: Tuesday, November 25

AstraZeneca and Ranbaxy pay-for-delay case marches on; FDA extends Novartis multiple myeloma Priority Review timeline; Endo pays $25 for testosterone nasal gel.

FDA tempers opioid approval impact

FDA tempers opioid approval impact

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.

Vancouver tests prescription heroin

The north-of-the-border solution comes amid climbing heroin abuse in the US.

India to reorg pharmaceutical agencies

The reason: coordination and effectiveness.

Five things for pharma marketers to know: Monday, November 24

Five things for pharma marketers to know: Monday, November 24

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.

Five things for pharma marketers to know: Friday, November 21

Five things for pharma marketers to know: Friday, November 21

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.

FDA approves abuse-deterrent Hysingla ER

The first approved hydrocodone formulated to discourage misuse raises a challenge to controversial Zohydro.

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