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Jazz Pharmaceuticals settled a seven-year long patent infringement suit over generic copies of its Xyrem solution for narcolepsy, just weeks before the case was scheduled to go to trial. Read More
A federal judge has ruled that a class-action antitrust lawsuit against several generics manufacturers, alleging price-fixing of propranolol capsules and tablets, can proceed in court. Read More
A federal appeals court upheld that a Novartis patent for its multibillion-dollar MS drug Gilenya is invalid, opening the door for generics as early as 2019. Read More
In a Senate committee markup scheduled for May 10, lawmakers will consider the next generation of the FDA’s generic user fee program, using dollar amounts negotiated over the last two years with industry. 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