Triggering a wave of commentary over its import, Biogen Inc. on Jan. 29 said the FDA has extended to June 7 its review of a BLA for the experimental Alzheimer's disease therapy aducanumab after the company submitted additional analyses and clinical data, making for a major amendment to the application. The three-month delay, from an earlier assigned PDUFA date of March 7, followed a thumbs-down vote by agency advisors in November. It sparked both sunny optimism and a bit of pessimism about the program's prospects on Friday.
Tonix Pharmaceuticals Holding Corp.’s failure last December in the phase III study called Recovery with TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 5.6 mg dented hopes for patients with civilian and military-related post-traumatic stress disorder (PTSD), but other developers remain in the game.
DUBLIN – Amid a bitter dispute between the European Commission (EC) and Astrazeneca plc over supplies of the latter’s SARS-CoV-2 vaccine, the EC’s drug regulator, the EMA, recommended approval of the product in question, COVID-19 Vaccine Astrazeneca (formerly AZD-1222).
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amarin, Arvelle, Ascentage, Bellicum, Biogen, Biontech, Eisai, Gan & Lee, Incyte, Karyopharm, Mabxience, Novartis, Novo Nordisk, Pfizer, RDIF, Roche, Stada, Tetra, Vertex.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: AC Immune, Fibrogen, Moleculin, Recordati, Rigel.
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