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.
Glaukos Corp. received a green light from the FDA for its Iprime device for the delivery of viscoelastic fluid during ophthalmic surgery, which could help the company to recover some of the revenue lost by cuts to reimbursement for its minimally invasive glaucoma surgery (MIGS) product, Istent. A launch date has not been announced.
Jelikalite Corp. has received a breakthrough device designation from the FDA for its wearable neurostimulation device Cognilum. The home-based system aims to reduce symptoms of moderate to severe autism spectrum disorder in pediatric patients aged 2 to 6 years. The designation was based on the results of a double-blind, placebo controlled clinical trial of 30 pediatric patients with moderate to severe autism, which showed the technology can significantly improve symptoms.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: BD, Glaukos.
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.
Bioventus Inc. has received FDA 510(k) clearance for a device that enables surgeons to remove bone in hard-to-work spaces during minimally invasive surgery. It acquired the company that developed the tool, Great Neck, N.Y.-based Misonix Inc., in October.
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.
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