DUBLIN – Affimed NV has found another taker for its tetravalent bispecific antibody-based innate cell engager (ICE) platform. Roivant Sciences GmbH is putting down $40 million in cash, plus another $20 million of its own stock, as part of a multiprogram alliance involving AFM-32 plus additional molecules directed at targets not currently addressed by Affimed’s pipeline. Some $2 billion in development, regulatory and commercial milestones are also attached to the deal. Read More
Now that the FDA has granted emergency use authorization to Eli Lilly and Co.’s bamlanivimab, the company plans to manufacture up to 1 million doses of the therapy by year-end with worldwide distribution to mild to moderate COVID-19 patients ages 12 and older in early 2021. Read More
HONG KONG, BEIJING and CAJICA, Colombia – Anvisa, Brazil’s health care surveillance agency, has halted the final-stage trials for Beijing, China-based Sinovac Biotech Ltd.’s COVID-19 vaccine candidate Coronavac after a serious adverse event occurred on Oct. 29 and was communicated to the regulator. Anvisa then evaluated the data and suspended the trials after weighing the risk-benefit of continuing them in the country, it said. Read More
According to an analysis conducted by BioWorld of the third-quarter 2020 financial reports filed by public biopharmaceutical companies with market caps greater than $1 billion, and excluding big pharma companies, the amount that was invested in research and development (R&D) during the nine-month period increased by almost 21% compared to the same period last year. The spending was bolstered by companies turning their attention to focus their research on therapies and vaccines to tackle COVID-19. Read More
LONDON – Biontech SE is looking ahead from the announcement on Nov. 9 of 90% efficacy in the interim analysis of the phase III trial of its COVID-19 vaccine to outline shipping and distribution plans. Read More
DUBLIN – Catalym GmbH pressed the accelerator on its growth differentiation factor 15 (GDF-15) inhibitor program by raising €50 million (US$59 million) in series B financing, which will fund a first-in-human study lined up to start before year-end. Read More
Arena Pharmaceuticals Inc. CEO Amit Munshi said “a cluster of patients in a single clinical site” skewed results of the phase IIb study testing etrasimod in atopic dermatitis (AD), and caused the selective S1P modulator to miss its primary endpoint. Read More
After a large jump of clinical news was reported in September, the momentum has continued throughout October, with an 8% increase over the prior month. Read More
The latest global regulatory news, changes and updates affecting biopharma, including: CDC updates vaccine guidance; Russia launches doctor-driven shortage reporting service; MHRA reviewing acne drug risks. Read More
New hires and promotions in the biopharma industry, including: Apnimed, Cerebral, Chinook, Genprex, IMV, Korro, Marinus, Nervgen, Novavax, Silverback. Read More
New and updated preclinical and clinical data presented by biopharma firms at the Society for Immunotherapy of Cancer’s annual meeting Nov. 9-14, including: Adaptimmune, Alligator, Amphivena, Anaveon, Bolt, Checkmate, Cue, Dcprime, Elicio, Evelo, Exicure, F-star, Ikena, I-Mab, Immatics, Immutep, IMV, Infinity, Istari, Leap, Medigene, Nanobiotix, Neoleukin, Nkarta, Onconano, Phio, Repertoire, Sensei, Seven and Eight, Surface Oncology, Xencor. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Betterlife, Clinigen, Emmaus, Forma, Immune-Onc, Lilly, Oryzon, Praxis, Rafael, Supernus. Read More
