This article was originally published in The Tan Sheet
The European Medicines Agency will hold a meeting Feb. 16-18 to discuss its review of COX-2 safety. EMEA's Committee for Medicinal Products for human use requested analyses on the cardiovascular disease risks of the drug class from Pfizer, Merck and Novartis. The agency's review began in October...
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The firm licensed the TLR9 agonist SD-101 from Dynavax to test with its pressure-enabled drug delivery technology in liver and pancreatic settings where immuno-oncology has shown moderate efficacy or less.
Given inconsistent study results, robustness of the efficacy evidence is expected to be key focus of the 6 November meeting of the Peripheral and Central Nervous System Drugs Advisory Committee; review could put a December 2019 guidance on the ‘substantial evidence’ standard to the test and offer insight into the amount of flexibility the agency is willing to exercise for neurodegenerative diseases with high unmet need.
CRLs FDA submits in response to ANDAs increased most years since FY 2015, though FY 2020 total likely will be lower than two previous years. A 2019 CRL interrupted GSK's plans to market first mouth spray nicotine replacement therapy in US.