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.
In another attempt to quell the opioid abuse epidemic, two FDA advisory committees voted Wednesday to recommend approval of an NDA for an immediate-release opioid painkiller. Read More
FDA commissioner nominee Scott Gottlieb was grilled by a Senate panel Wednesday over his financial ties to the industry he would be charged with regulating. Read More
A federal judge ruled that three generics manufacturers infringed on Novartis’ patents related to its Zortress treatment, used during kidney and liver transplants. Read More
Three drugmakers have filed amicus briefs in support of Regeneron and Sanofi’s efforts to reverse a district court ruling that validated Amgen patents on Repatha and barred the companies from selling their cholesterol drug Praluent. Read More
President Trump released a budget blueprint calling for FDA user fees to rise to more than $2 billion for fiscal 2018 — up from the $1.36 billion set for 2017 — and for $1 billion to fund the 21st Century Cures Act. Read More
South Korean biosimilars firm Celltrion is challenging the validity of four Genentech patents for combination therapies to treat metastatic breast cancer. Read More
A broad group of industry organizations is urging the FDA to delay its quality metrics reporting program, which would require drugmakers to aggregate information on the number of lots started, released for distribution and found out-of-specification, as well as the number of quality complaints reported. Read More
International generic drug regulators have published a report template for biowaiver assessments to better reconcile varying biowaiver requirements among regulatory authorities. Read More
An industry group and two drugmakers have filed briefs in the Supreme Court backing Amgen’s request that a federal circuit ruling be partially affirmed to mandate that biosimilar makers share information and wait six months after an FDA approval to launch a therapy. Read More