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Drugmakers seeking approval of products with hormonal effects should submit an assessment with their applications that evaluates whether they would be harmful if released into the environment. 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The UK’s National Institute for Health and Care Excellence issued draft guidance Friday on two prostate cancer drugs, recommending Bayer’s Xofigo while declining to endorse Ferring Pharmaceuticals’ Firmagon.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
Health Canada has launched an online public database of information relating to drug company inspections, including which firms have a good history of meeting safety and quality standards and which do not. Read More
Particulates have forced yet another drugmaker — this time Teva — to recall an injectable. The drugmaker voluntarily recalled eight lots of its anticancer therapy Adrucil after a combination of silicone rubber from a filling diaphragm and fluorouracil crystals was found in vials. Read More