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The European Medicines Agency’s decision to redact certain personal and commercial information from clinical study reports before releasing them to a private citizen did not violate EU transparency policy, the European ombudsman says. Read More
European regulators have granted accelerated assessment for GlaxoSmithKline’s antiseptic chlorhexidine gel for the prevention of umbilical cord infections. Read More
The FDA hit another Indian active pharmaceutical ingredients maker with a warning letter after an inspection revealed data integrity issues and significant cGMP violations. Read More
Roseville, Minn.-based Rebiotix has been granted FDA breakthrough therapy status for its lead product RBX2660 to treat recurrent Clostridium difficile infection. Read More
Sun Pharmaceuticals has quietly dropped an appeal of a lawsuit challenging the FDA’s authority to revoke the tentative approval of two generics made by its Ranbaxy subsidiary. Read More
California Gov. Jerry Brown (D) Sunday vetoed a bill that would have allowed drugmakers to make experimental therapies available to terminally ill patients if recommended by two doctors, saying the FDA’s compassionate use program should be given a chance to work. Read More
A British charity is pledging roughly $154 million over the next five years toward research into treatments and diagnostics to improve cancer survival. Read More
The FDA is warning healthcare providers and patients not to use sterile drugs made by an Oklahoma compounder after the firm refused to cease sterile operations following a failed inspection — the latest in a stream of safety alerts, warning letters and Form 483s having to do with compounders’ sterility practices over the past year. Read More
Eli Lilly is suspending development of its leading heart drug candidate evacetrapib after an independent data monitoring committee determined it wasn’t effective in a Phase 3 clinical trial. Read More