Skeptical briefing documents pertaining to the U.S. FDA’s adcom meeting on Y-mabs Therapeutics Inc.’s Omblastys (131I-omburtamab) turned out predictive of the less-than-happy outcome, as the regulator’s Oncologic Drugs Advisory Committee (ODAC) turned thumbs down on the prospective drug for pediatric central nervous system/leptomeningeal metastasis from neuroblastoma. Read More
The U.S. FDA declined to approve Gilead Sciences Inc.’s Hepcludex (bulevirtide), issuing a complete response letter (CRL) citing manufacturing and delivery concerns for the antiviral aimed at treating confirmed chronic hepatitis delta virus (HDV) infection in adults with compensated liver disease. Acquired in Gilead’s 2021 buyout of Myr GmbH, Hepcludex received conditional approval from the European Commission in 2020 and would have been the first drug cleared for HDV in the U.S. Its delay, however, could give a boost to Eiger Biopharmaceuticals Inc., which is expected to report phase III data for lonafarnib by the end of 2022. Read More
Nearly six months after ditching its phase II/III COVID-19 vaccination study to chase a booster strategy, Inovio Pharmaceuticals Inc. is now ditching the heterologous booster. The decision to stop internally funding INO-4800 as a booster was made after sifting through data on global demand for COVID-19 vaccines, the condition of the market and Inovio’s own portfolio. Read More
Clinical data through the last week of October 2022 has dropped 17% in comparison with 2021. So far in 2022, there have been a total of 2,812 phase I, II and III clinical entries, compared with 3,389 during the first 10 months of 2021. Read More
Circuit dysfunction is clearly recognized as a driver of neuropsychiatric disease, and some neurodegenerative diseases such as Parkinson’s disease. And at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2022 Congress, researchers made an argument that the same is true in multiple sclerosis (MS). Such a lens could explain the radiological-clinical paradox between the amount of structural damage and clinical severity. Read More
The potential for psychedelics to deliver long-lasting benefits for people with anxiety, depression, post-traumatic stress disorder and addiction is being put to the test in Australia, where new research and discovery centers are adding to a global enterprise of nearly 100 clinical trials underway in the space. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Agios, BMS, Flare, Immunogen, Obsidian, Rila. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avrobio, Diamedica, Dyadic International, ITM Isotope Technologies München, Myeloid, Novo Nordisk, Reveragen, Santhera, Simcere. Read More
