In an unusual move, three members of the Nov. 6 FDA advisory committee that voted against recommending approval of Biogen Inc.’s high profile Alzheimer’s disease candidate, aducanumab, have doubled down on their argument in an editorial published in JAMA on March 31.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Autolus, Beyondspring, Lannett, Moderna, Neurophth, Respirent, Sanofi, Secura, Taiho, United.

“Our position has not changed,” said Emer Cooke, executive director of the EMA, giving an update on the agency’s investigation into cases of the rare clotting disorder cerebral venous sinus thrombosis (CVST) in people vaccinated with Astrazeneca plc’s COVID-19 vaccine. “There is no evidence to support restricting use of the vaccine in any population,” she said.

HONG KONG – Seikagaku Corp. and Ono Pharmaceutical Co. Ltd. have cleared the final hurdle for Joyclu (diclofenac etalhyaluronate sodium), with Japan’s Ministry of Health, Labour and Welfare granting manufacturing and marketing approval for the osteoarthritis (OA) therapy, the first agent to be approved in Japan for improving hip joint function in OA. The intra-articular injection was also approved for the treatment of knee joint OA.

The latest global regulatory news, changes and updates affecting biopharma, including: FDA to hold adcom on T1D drug; GHIT invests $21M; MHRA updates guidance.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Affimed, Amryt, Celltrion, Cstone, CTI, Everest, Evive, Exelixis, Innovent, Ipsen, Jazz, Mabxience, Nkmax, Opthea, Provention, SK, Surface Oncology, Syndax, Zai.

The latest global regulatory news, changes and updates affecting biopharma, including: MRNA vaccine efficacy holds in real world; TGA addressing drug shortages; STIs on the rise in U.S.; CDER firm on Makena withdrawal.

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, ABL, Akebia, Amarin, Biom, Cara, Curevo, Eisai, Genmab, Horizon, I-Mab, Incyte, Intellia, JCR, Karyopharm, Merck, Moleculin, Myovant Sciences, PTC, RDIF, Stoke, Tiziana, Tetra, Vifor.