We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Some melanoma patients in the EU will now have access to GlaxoSmithKline’s Mekinist, following the European Commission’s approval of the drug as a single agent for patients with unresectable or metastatic disease fueled by a BRAF V600 mutation. Read More
Clinical research firm Clinipace Worldwide wants the FDA to sign off on a generic version of Merck’s osteoporosis drug Fosamax by declaring that three strengths of the drug were not discontinued for safety or effectiveness reasons. Read More
The FDA and Customs and Border Protection last month began accepting applications for an 18-month pilot of a “trusted trader” program to reduce inspections and oversight of imports from drugmakers that establish tough internal import control programs of their own. Read More
With a deadline looming, the pharmaceutical industry still needs to decide which data systems are most efficient and cost-effective for implementing the federal track-and-trace law, experts say. Read More
Companies throughout the drug supply chain that encounter suspected counterfeit products should file a report with the FDA and any affected trading partner within 24 hours, the agency says. Read More
The generic drug industry wants the FDA to ensure new requirements for packaging and technologies aimed at curbing opioid abuse don’t result in barriers to market entry for generic makers. Read More
Teva is still fighting to keep generic versions of its blockbuster multiple sclerosis drug Copaxone off the market, with its seventh citizen’s petition asking the FDA to mandate that any ANDA on the product undergo extra levels of bioequivalence testing. Read More
Tramadol manufacturers have approximately 45 days to implement new labeling and security procedures now that the Drug Enforcement Administration has determined the opioid analgesic is a Schedule IV controlled substance. Read More
Indian generics maker Lupin Pharmaceuticals is being sued by Valeant Pharmaceuticals subsidiary Bausch + Lomb and Senju Pharmaceuticals over its ANDA for Prolensa eye drops. Read More