LONDON – A fourth COVID-19 vaccine is on the road to approval in Europe, with Novavax Inc. announcing positive interim data from the phase III U.K. trial of NVX-CoV2373. The vaccine was 89.3% effective at a time when there was a high rate of infection in the country, and in the face of the newly identified variant, B 1.1.7, which is more transmissible. There also was positive data, though slightly less sparkly, from a phase IIb study in South Africa, where NVX-CoV2373 showed 60% efficacy in preventing mild, moderate and severe COVID-19 disease. Read More
Sweeping in behind Novavax Inc.’s positive phase III COVID-19 vaccine data is Johnson & Johnson’s single-shot COVID-19 vaccine, which met all the primary endpoints and key secondary endpoints in its phase III study, according to an interim analysis that found it to be 85% effective overall in preventing severe disease. Read More
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). Read More
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. Read More
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. Read More
New hires and promotions in the biopharma industry, including: Exacis, Genfit, Medipharm, Oncology Pharma, Oncternal, Orchard, Oncxerna, Puretech. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Astrazeneca, Auris, Daiichi Sankyo, Humanigen, Innovation, J&J, Nanobiotix, Novavax, Orion, Ovoca, Puma, Redhill, Turning Point. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: AC Immune, Fibrogen, Moleculin, Recordati, Rigel. Read More
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. Read More
