Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ampio, Cyclo, Eledon, Enzyvant, Hillhurst, Instil, Krystal, RDIF, Reata, Revive, Rockwell Medical, Sol-Gel Technologies.
The Medical Device Innovation Consortium (MDIC) has been hard at work on the Make CAPA Cool program in an effort to beef up device makers’ corrective and preventive action (CAPA) programs. Kathryn Merrill, regulatory program director for Dublin-based Medtronic plc, said on an April 26 webinar that participants in the program have shaved CAPA times from 381 days to as few as 63 days, an improvement that industry hopes will ward off warning letters and product quality issues.
The FDA has granted de novo authorization to Neurolutions Inc. for its Ipsihand upper extremity rehabilitation system. The first-of-its kind device leverages robotics and brain-computer interface (BCI) technology to facilitate muscle training in patients with upper limb weakness or immobility following a stroke.
Depression treatment still isn’t “once and done,” but the time needed to reduce symptoms continues to drop for patients using electromagnetic stimulation. Brainsway Ltd.’s Theta Burst brings treatment times down to just three minutes with its FDA 510(k) clearance.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: PTAB rejects 3Shape’s attempt to invalidate claims for Align patent.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Brainsway, Lucira Health, Neurolutions, Phoenix Cardiac, Speedx.
As part of a U.S. FDA evaluation of confirmatory trials for anti-PD-1/PD-L1 antibodies, the agency’s Oncologic Drugs Advisory Committee (ODAC) is being asked this week to consider whether three blockbuster biologics should continue to be available for certain cancer indications for which they received accelerated approval. At question is whether the data from the confirmatory trials for the Roche Group’s Tecentriq (atezolizumab), Merck & Co. Inc.’s Keytruda (pembrolizumab) and Bristol Myers Squibb Co.’s Opdivo (nivolumab) has proved sufficient benefit in particular indications and, if not, whether alternative or ongoing trials could do so.
The FDA has approved Roche AG’s Ventana MMR Rxdx panel for patients with advanced or recurrent endometrial cancer. The companion diagnostic is the first to identify patients who are eligible for treatment with Glaxosmithkline plc’s (GSK’s) Jemperli (dostarlimab-gxly) monotherapy. The PD-1 antibody immunotherapy received FDA approval on Thursday.
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