Moderna Inc. gained U.S. FDA approval on May 31, nearly three weeks past its original PDUFA date, for its respiratory syncytial virus (RSV) vaccine Mresvia (mRNA-1345), which had both breakthrough therapy and fast track designations in the U.S. Read More
Ultragenyx Pharmaceutical Inc. anticipates a meeting later this year with the U.S. FDA to discuss a BLA filing for gene therapy DTX-401 as the first potential medical treatment for glycogen storage disease type 1a (GSD1a) after the phase III study hit its primary endpoint and two key secondary endpoints. Read More
Although details are scant, Akeso Pharmaceuticals Inc. reported that its PD-1/VEGF bispecific antibody, ivonescimab (AK-112), demonstrated statistically significant superiority as a first-line therapy for PD-L1-positive non-small-cell lung cancer (NSCLC) compared to Merck and Co. Inc.’s Keytruda (pembrolizumab). Read More
The American Society of Clinical Oncology (ASCO) meeting opened at the McCormick Place convention center in Chicago with after-lunchtime sessions on breast cancer, melanoma, sarcoma and advancements on adjuvant cancer vaccines. As ASCO revved up, the CEOs of Merck & Co. Inc., Gilead Sciences Inc. and Eli Lilly and Co. vented their frustrations about the impact of the Inflation Reduction Act on innovation. Read More
Obesity specialist Sixpeaks Bio AG emerged from stealth with $110 million in funding and an option to be acquired by Astrazeneca plc within the next two years, subject to filing an IND for the lead product. Read More
In 2024, the value of biopharma nonprofit deals is tracking slightly higher than the previous year, but still significantly lower than the value seen in prior years. Meanwhile, grants to biopharma firms have dropped by more than 50% compared to last year’s monthly average. The U.S. Department of Defense emerged as the leading grant issuer to biopharma firms, and also saw the highest-value nonprofit deal in the sector. Read More
Scientists from the PsychENCODE Consortium have analyzed the brain transcriptome in a coordinated series of studies to map all the cell types, genes, epigenetic factors, and molecular pathways involved in different psychiatric disorders. After a first set of projects based on bulk analysis, the second phase of this project included 14 simultaneous publications that revealed the cellular atlas of post-traumatic stress disorder and major depressive disorder, among others. Read More
Chris Bardon, a co-managing partner at MPM Bioimpact, shares her insights into the American Society of Clinical Oncology (ASCO) conference. She talks about the major trends in oncology, including development of antibody drug conjugates, which is currently the hottest area in cancer treatment. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Bridgebio, Cyclo, Elevar, HLB, Inxmed, Soterios, Xeris. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adaptimmune, Anocca, Day One, Escient, Incyte, Inhibrx, Galapagos, Kvanctify, Purminds, Sanofi, Shinobi, Tetra Pharma, Verona, Viracta. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB Science, Candel, NH Theraguix, Teva. Read More
