The U.S. FDA’s formation of the Digital Health Center of Excellence was heralded as a key enabler of digital health technologies, but the news hasn’t necessarily had the expected effect. The agency’s December 2021 draft guidance on the use of digital health technologies to assist in the conduct of clinical trials is still in regulatory drydock.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amneal, Aston, Biontech, Genentech, Immusoft, Moderna, Pfizer, Roche, Sanofi.
Irked by what state officials described as "bureaucratic roadblocks" to Florida's proposal for importing cheaper prescription drugs from Canada, Florida Gov. Ron DeSantis on Aug. 31 announced a state lawsuit against the U.S. FDA.
In the hope of preventing thousands of hospitalizations and deaths over the next few months, the U.S. CDC’s Advisory Committee on Immunization Practice (ACIP) voted 13-1 Sept. 1 to recommend the use of Moderna Inc.’s and Pfizer Inc.-Biontech SE’s updated vaccines that contain components of both the original SARS-CoV-2 virus and the omicron BA.4/5 subvariants as boosters.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aquestive, Ascendis, Biocryst, Epiendo, Innocare, Maze, Nanomerics, Novartis, Scilex, Synox, Trethera, United Biopharma.
Access to advanced therapies proved to be a major talking point at a conference in London, following the U.S. approval of Bluebird Bio Inc.’s Zynteglo (betibeglogene autotemcel) cell-based gene therapy for beta thalassemia and its $2.8 million price tag. Regulators in Europe backed Zynteglo in 2019 but Bluebird opted to withdraw the therapy in 2021 after deciding that the complex thicket of pricing bodies in Europe was too difficult to negotiate.
Five months after winning its first approval in Japan, Sanofi SA’s enzyme replacement therapy, Xenpozyme (olipudase alfa), earned a U.S. FDA nod for use in pediatric and adult patients with acid sphingomyelinase deficiency (ASMD), becoming the first medication designed to treat symptoms not related to the central nervous system.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Bavarian Nordic, Biocytogen, Biogen, Curis, Daiichi, Jaguar, Moderna, Novavax, Okyo, Outlook, Sanofi, Sobi, Stemcyte, Takeda, Y-mabs.
Right on cue, the U.S. FDA authorized bivalent COVID-19 vaccines from Moderna Inc. and Pfizer Inc.-Biontech SE to be given as boosters at least two months following a primary vaccine series or a previous booster. “These updated boosters present us with an opportunity to get ahead of the next wave of COVID-19,” FDA Commissioner Robert Califf said, following the Aug. 31 announcement.
While it will need a “reasonable period of time” to do so, Turkey said Aug. 29 that it intends to establish a level playing field for foreign and domestic drug producers in accordance with the recommendations and rulings of World Trade Organization dispute arbitrators.
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