Little more than six months after filing a BLA for the antibody-drug conjugate (ADC) tisotumab vedotin in recurrent or metastatic cervical cancer, Seagen Inc. and Genmab A/S have secured an accelerated approval for the medicine. The green light for the co-developed product marks Seagen's third approved ADC and Genmab's first marketed therapy, though another medicine based on its Duobody technology platform recently won approval, too. The new cervical cancer drug, to be marketed as Tivdak, was approved for the treatment of adults experiencing disease progression on or after chemotherapy. Read More
Fresh data from Johnson & Johnson show COVID-19 protection dramatically increased with a booster shot of its single-dose vaccine, adding momentum to the U.S. drive for boosters. Read More
858 Therapeutics Inc. emerged from stealth mode, unveiling $60 million in series A funding and plans to drug a series of protein targets involved in modulating RNA biology in cancer. Read More
Everest Medicines Ltd. has in-licensed a Bruton’s tyrosine kinase (BTK) inhibitor for the treatment of renal diseases from Suzhou Sinovent Pharmaceuticals Co. Ltd. and Sinomab Bioscience Ltd. in a deal worth up to $561 million. Everest gained global rights to develop, produce and commercialize the candidate, XNW-1011. Read More
Enacting provisions to control U.S. prescription drug prices remains a top priority with many members of Congress as they push through the Biden administration’s budget agenda – despite warnings that government price controls on drugs would come at the cost of innovation. Read More
Verrica Pharmaceuticals Inc.’s launch plans for drug-device candidate, VP-102 (cantharidin 0.7% topical solution), in the viral skin infection molluscum contagiosum were hit with another delay, as the FDA issued a complete response letter (CRL) in response to the NDA, just two days ahead of its Sept. 23 PDUFA date. Read More
New and updated preclinical and clinical data presented by biopharma firms at the European Society for Medical Oncology Congress 2021, including: Astellas, Astrazeneca, Beyondspring, Byondis, Carsgen, Cstone, Daiichi, Exelixis, Genentech, Genmab, GT, Innovent, Immunocore, Ipsen, Janssen, Merck, Mirati, Novartis, Ose, Regeneron, Sanofi, Spectrum, Verastem, Veru. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Amgen, Abexxa, Astrazeneca, Black Diamond, Boehringer, Clearmind, Faes, FSD, Hemoshear, Horizon, Lucid, Novartis, Openeye, Sandoz, Yissum, Zydus. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biogen, Biontech, Celltrion, Exelixis, Forge, Incyte, Luye, Marinus, Pfizer, Rhythm, Samsung. Read More
BioWorld will provide live updates during the Sept. 23-24 meeting of the CDC’s Advisory Committee on Immunization Practice on COVID-19 boosters. Watch your email inbox for breaking news bulletins that will include a link or visit bioworld.com. Read More
