The U.S. Supreme Court preserved the U.S. Preventative Services Task Force coverage mandate that requires payers to cover certain preventive services at no cost to patients in a 6-3 ruling. That’s very good news for many diagnostics companies including Exact Sciences Corp. and Guardant Health Inc. as well as companies that manufacture HIV pre-exposure prophylaxis (PReP) medications such as Gilead Sciences Inc.
Industry’s reaction to the U.S. FDA’s draft guidance for remote regulatory assessments included a request for more clarity on when the agency would issue a post-assessment report, but the final guidance makes clear the FDA sees no compelling reason to issue such a report in every instance.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aldeyra, Biocity, Carsgen, Emmaus, Pint, Theravance, Viatris.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: CDR-Life, CSL, Hummingbird, Kalvista, Northern Antibiotics, Novartis, Pendopharm, Percheron, Profound, Prokaryotics, Valneva.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alebund, Altimmune, Alto, Crispr, Edgewise, Gri, I-Mab, Invivyd, Lisata, Metabolics, Opus, Pfizer, Viatris.
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