Valrox (valoctocogene roxaparvovec) from San Rafael Calif-based Biomarin Pharmaceutical Inc. moved one step closer to entering the U.S. market, with the company reporting that that the FDA had accepted for priority review the BLA for its investigational AAV5 gene therapy for adults with hemophilia A.
Less than a month after landing a positive opinion from the EMA's CHMP, Esperion Therapeutics Inc. has won FDA approval for bempedoic acid as an adjunct to diet and maximally tolerated statin therapy.
The U.S. Centers for Medicare and Medicaid Services (CMS) announced it may tack on another three years to the Comprehensive Care for Joint Replacement (CJR) program, proposing among other things to drop the 50% cap on gainsharing payments. Analysts with Cowen Washington Research Group, of New York, said post-acute care providers are at greater risk than device makers with the extension, however, due to the fact that hospitals have several choices in terms of discharge destination, including the patient’s home.
During a conference call with investors, Baudax Bio Inc. CEO Gerri Henwood let out an exuberant “woohoo!” to celebrate the FDA’s approval – after two turndowns and much haggling over data – of Anjeso (meloxicam) for moderate to severe pain. Echoing her sentiment was Piper Sandler analyst David Amsellem. “It’s nice to see the pain division finally get this one right,” he said.
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