The latest global regulatory news, changes and updates affecting medical devices and technologies, including: HHS provides details of Binax test distribution.

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: 2bprecise, Accumen, AZ Tech MRI & Radiology, Calibre Scientific, Centinel Spine, Civatech Oncology, Commonspirit, Corventive Health, Cytiva, Dianova, Discovery Life Sciences, Enzo Biochem, Eon, Exergen, Halfpenny Technologies, Hancock Jaffe, Imbio, Mc10, Medidata, Paramit, Radnet, S.I.E Solutions, Siemens Healthineers, Tae Life Sciences, Tecan, Thermo Fisher Scientific, Trimedic, Vidence.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Baxter, Magnolia Medical.

The ACTIV-3 phase III study testing Eli Lilly and Co.’s COVID-19 antibody candidate, LY-CoV555, which was paused two weeks ago following a participant’s unexplained illness, has now been halted, the company reported Oct. 26.

The latest global regulatory news, changes and updates affecting biopharma, including: FDA clarifies terms for generics; FDA to hold public meeting on DSCSA; Russia updates COVID-19 guidelines; First Circuit: Prescriber’s perk indeed a kickback; Companies warned for documentation, FAR violations.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascentage, Atai Life, Cytodyn, Edigene, Exelixis, Kala, Moderna, Nektar, Pfizer, Prevail, RDIF, Vanda.

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alterity, Alzamend, Amerimmune, Appili, Bioinvent, CASI, Compugen, Daewoong, Effector, Eloxx, Essa, Fusion Antibodies, Hemogenyx, Histogen, Immunoprecise, Immunos, Lodo, Neximmune, Novasep, Ology, Phosplatin, Probiogen, Regenxbio, Roche, Sareum, Sensorion, Twist, Vaxil.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aerpio, Alligator, Alzheon, Amgen, Bridgebio, Catabasis, Eisai, Ellodi, Genetx, Iveena, Lilly, Novavax, Olatec, Oncolytics, Pfizer, Phoenix Tissue Repair, Prilenia, Rafael, Reata, Scholar Rock, Sumitomo Dainippon, Syntrix, Takeda, Transgene, Ultragenyx.

The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Medtronic advises of problems with Interstim leads; Palmetto eyes coverage of CT for cerebral perfusion.