Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Helius Medical Technologies, Medtronic, Qiagen, STS Lab.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Canada invests in variant research; Time needed to develop immunity with Sputnik V.
The first BCMA-targeted CAR T therapy, idecabtagene vicleucel, cleared FDA approval for use in adults with multiple myeloma (MM) who have received four or more prior lines of therapy. Developed by partners Bluebird Bio Inc. and Bristol Myers Squibb Co., the drug, branded Abecma, is also the first CAR T drug indicated for MM. It is designed for use as a one-time infusion, with a recommended dose range of 300 to 460 x 106 CAR-positive T cells. The personalized therapy will be produced at BMS’ cellular manufacturing facility in Summit, N.J. Bluebird developed the lentiviral vector used in Abecma.
The latest global regulatory news, changes and updates affecting biopharma, including: Time needed to develop immunity with Sputnik V; CRS: Rutledge opens door to more PBM reforms.
South San Francsico-based Twist Bioscience Corp. and Biotia Inc., of New York, received the first FDA emergency use authorization (EUA) for a capture-based next-generation sequencing (NGS) assay for the coronavirus that causes COVID-19. The technique reduces the likelihood of misdiagnosing or failing to identify mutations compared to standard sequencing.
TORONTO – A distinguished Canadian health care policy expert said a report from Canada’s COVID-19 Testing and Screening Expert Advisory Panel recommending testing and screening for school-age children and teachers comes “late in the game” now that the focus has shifted to vaccinating the Canadian population.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA approves Harmony device to treat patients with congenital heart disease.