Biotech Consolidation: Even News is No News
The only thing more noteworthy about the recent biotech M&A is than its volume is the silence that surrounds it: from Wall Street, the press, and Big Pharma. The problem is the consolidations themselves: largely intra-biotech affairs. Unless Big Pharma gets involved--and they've shown no interest in doing so--investors aren't going to get paid in what they want most out of an acquisition: liquid currency.
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Not Your Grandfather’s CAPA: Case For Quality Pilot Gives Corrective And Preventive Action A Facelift
Big changes are afoot when it comes to CAPA. Ten medtech manufacturing sites are playing in a pilot program that uses a novel framework that shifts corrective and preventive action from a one-size-fits-all method to a more nuanced approach that separates higher-risk events from others that don’t need to be elevated to the level of a traditional CAPA. Medtronic quality/regulatory expert Kathryn Merrill weighs in.
Pembrolizumab should be considered the new standard of care as first-line therapy in patients with microsatellite instability high (MSI-H) metastatic colorectal cancer, KEYNOTE-177 investigator André said.
Amivas requested a US tropical disease PRV for intravenous artesunate but FDA has not yet made a decision on eligibility; approval appears to block La Jolla’s competing product, currently under review, for seven years.