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Amgen’s injectable Repatha proved effective in lowering bad LDL cholesterol in a series of Phase 3 trials, but the FDA says some safety concerns remain. Read More
Democratic members of the House Energy & Commerce Committee are pressing the FDA to expand the black box warning on extended-release opioids to include immediate-release versions of the painkillers as well. Read More
Orexigen Therapeutics and Takeda filed a patent infringement suit in federal court aimed at blocking Actavis from marketing a generic version of their anti-obesity drug Contrave. Read More
The European Medicines Agency issued revised guidance on classification of advanced therapy medicinal products and the information that sponsors need to submit to the agency. Read More
Sanofi and Regeneron’s biweekly injectable Praluent effectively lowers bad LDL cholesterol and has few side effects, the FDA says in briefing materials released ahead of a Tuesday advisory committee meeting. Read More
The UK’s National Institute for Health and Care Excellence issued draft guidance Friday on two prostate cancer drugs, recommending Bayer’s Xofigo while declining to endorse Ferring Pharmaceuticals’ Firmagon. Read More
Buyers of heartburn drug Nexium are seeking an injunction against Ranbaxy and AstraZeneca in pay-for-delay litigation, arguing that their motion is supported by a recent Second Circuit ruling upholding an injunction requiring Actavis to keep an older version of Alzheimer’s drug Namenda on the market. Read More
ISPE’s Quality Metrics Pilot Program shows that it’s feasible for drugmakers to collect and submit a standardized set of metrics data to the FDA, but not without considerable cost, a final report on phase one of the pilot concludes. Read More
The NIH Clinical Center suspended operations of its Pharmaceutical Development Section, effective Thursday, due to serious manufacturing problems and lack of compliance with standard operating procedures discovered during an FDA investigation. Read More