In a mammoth deal with a potentially huge payoff, Nurix Therapeutics Inc. and Seagen Inc. will collaborate to develop what they call a new class of medicines, Degrader-Antibody Conjugates, to create drugs with new mechanisms of action for treating cancer. Read More
On track to move its lead candidate, MC-339, into the clinic for small-cell lung cancer in 2024, Mariana Oncology Inc. raised $175 million through an oversubscribed series B round co-led by Deep Track Capital and Forbion. The radiopharmaceutical company was incubated for 18 months before raising $75 million through a series A in December 2021, and has since built out its R&D division and a phase I/II manufacturing unit. It currently has 50 employees. Read More
As part of its quest to advance its three first-in-class heart failure drug candidates toward the clinic, Corteria Pharmaceuticals SAS has closed an oversubscribed €65 million (US$70.7 million) series A, co-led by investors Orbimed and Jeito Capital, companies based in the U.S. and Europe, respectively. Read More
While the U.S. FDA’s preclinical and clinical trial framework is generally well-suited to adapt to the use of artificial intelligence (AI) in developing new drugs, its regulatory framework for medical devices that incorporate evolving AI leaves a lot to be desired, according to Sen. Bill Cassidy (R-La.), the ranking member of the Senate Health, Education, Labor and Pension Committee. Read More
South Korean biopharmaceutical firms are facing a harsher climate and an uphill battle both domestically and abroad, amid the larger economic downturn that has slowed everything from new drug approval to dealmaking. At the Global Pharma Key Opinion Leaders (GPKOL) 2023 Symposium held at the El Tower on Sept. 7 in Seocho-gu, Seoul, officials from the industry, government and academia gathered to discuss strategies on bouncing back from the lasting effects of the COVID-19 pandemic. Read More
China’s National Medical Products Administration (NMPA) has given the green light to Gloria Biosciences Co. Ltd.’s anti-PD-1 monoclonal antibody, zimberelimab (Yutuo, GLS-010), for treating second-line cervical cancer, making it the first immune checkpoint inhibitor approved in China for treating the disease. Read More
Shares of Corvus Pharmaceuticals Inc. (NASDAQ:CRVS) sank 21.5% on Sept. 7, even though the company confirmed a phase III plan with the U.S. FDA for its ITK inhibitor, soquelitinib, to treat relapsed peripheral T-cell lymphoma (PTCL). Read More
Astellas Pharma US Inc. voluntarily withdrew its constitutional challenge Sept. 6 to the Inflation Reduction Act’s (IRA) drug price negotiations. Read More
Two U.S. federal government departments recently issued a series of guidelines for their handling of mergers and acquisitions in a draft that has provoked both support and opposition from observers. Barry Nigro of the George Washington University School of Law said he is concerned that the presumption that a transaction is necessarily anticompetitive will prompt litigation over that presumption and thus bog down the process of reviewing these transactions. Read More
Google’s Scott Penberthy joins the podcast for a visionary discussion that scans the horizon for startling changes artificial intelligence will bring to drug development in the relatively near future. Read More
New hires and promotions in the biopharma industry, including: Anokion, Crispr, Engene, Hepion, Medincell, Oncternal, One Biosciences, Rapport, Vividion. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biocytogen, Bioinvent, Elicio, Exelixis, Fate, Myricx, Shoreline. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Applied Therapeutics, Astrazeneca, Atamyo, Bridgebio, Cantargia, Genentech, Gloria, Neurophth, Realta, Tango. Read More
