Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Belkin Vision, Cryofocus, Zimvie.
Nextpoint Therapeutics Inc. has received FDA clearance of its IND application for NPX-887, a fully human monoclonal antibody targeting HHLA2 (B7-H7), a novel immune checkpoint and tumor target antigen highly expressed in many cancers independently of PD-L1.
Vittoria Biotherapeutics Inc. has received FDA clearance of its IND application to initiate a first-in-human phase I trial with VIPER-101, a gene-edited, autologous, chimeric antigen receptor (CAR) T-cell therapy for treatment of patients with relapsed or refractory T-cell lymphoma.
Both Vertex Pharmaceuticals Inc.’s Casgevy (exagamglogene autotemcel, exa-cel) and Bluebird Bio Inc.’s Lyfgenia (lovotibeglogene autotemcel, lovo-cel) received U.S. FDA approval Dec. 8, providing 16,000 American sickle cell patients who have recurring vaso-occlusive events with access to the first cell-based gene therapies.
After a nine-month review, the Biden administration is preparing to go where all other U.S. administrations have refused to trod. In releasing a draft framework to help federal agencies decide whether to exercise a federal march-in on patent rights protecting taxpayer-supported drugs and other inventions, including medical devices.
Biospectal SA has received a CE MDR class IIa medical device certification for its optical fingertip blood pressure monitoring app, Optibp. The device records fingertip blood flow optically and transforms the information into a pulse wave that it analyzes to estimate blood pressure.
The U.S. FDA’s draft rule for lab-developed tests (LDTs) has proven to be every bit as controversial as expected, although the controversy is only marginally about the workload that would come with rulemaking.
After a nine-month review, the Biden administration is preparing to go where all other U.S. administrations have refused to trod. In releasing a draft framework to help federal agencies decide whether to exercise a federal march-in on patent rights protecting taxpayer-supported drugs and other inventions, including medical devices, the Department of Commerce’s National Institute of Standards and Technology included price as a factor in considering whether a product is “reasonably” available, as required under the 1980 Bayh-Dole Act.
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