Where’s the plan? That was the underlying question Jan. 11 as Biden administration health officials faced frustration and tough questions from both Democrats and Republicans on the Senate Health, Education, Labor and Pensions (HELP) Committee about how the U.S. government is responding to the surge of COVID-19 infections caused by the omicron variant.
This could be a make-or-break week for Biogen Inc., with the U.S. Centers for Medicare & Medicaid Services (CMS) expected to announce a draft coverage decision for the company’s Alzheimer’s drug, Aduhelm.
After 25 years of research. Allschwil, Switzerland’s Idorsia Ltd. has had its first drug approved by the FDA – Quviviq (daridorexant) for adults with insomnia. The okay for Quviviq is the result of painstaking research led by the firm’s chief scientific officer, Martine Clozel, whose husband Jean-Paul Clozel is CEO.
FDA commissioners past, present and likely future gathered together for a rare joint discussion Jan. 9, as part of the third annual Innovations in Regulatory Science Summit.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Dynacure, Moderna, Paxmedica.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akeso,
Astex, Atyr, Beigene, Freeline, Jubilant, Otsuka, Pharming, Regenxbio, Vaxcyte, Zai.
Within hours of a Jan. 5 vote on COVID-19 boosters for adolescents, U.S. CDC Director Rochelle Walensky endorsed the Advisory Committee on Immunization Practices’ (ACIP) recommendation that all adolescents aged 12-17 years should receive a booster dose five months after their primary series. The recommendation applies to the Pfizer Inc.-Biontech SE COVID-19 vaccine, as it’s the only one authorized in the U.S. for use in adolescents.
The U.S. Patent and Trademark Office (PTO) has been scrambling to adjust to recent developments in case law for patent subject matter eligibility, and the latest PTO response is a pilot program for new patent applications.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allovir, Alphamab, CSPC, Nrx, Oncolyze, Oncotelic, Oncternal, Samsung, Simcere.
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