Aviadobio Ltd. has entered a potential $2.18 billion license and commercialization agreement for its frontotemporal dementia gene therapy, AVB-101, with Astellas Pharma Inc. Astellas is making a $20 million equity investment in London-based Aviadobio and will pay up to $30 million up front in advance of deciding whether or not to exercise the exclusive option to worldwide rights. Read More
Mestag Therapeutics Ltd. has sealed a potential $1.9 billion agreement with Merck & Co. Inc., in which it will apply its expertise in activated fibroblasts to identify novel targets for inflammatory diseases. The pharma company has the option to license one or more targets, up to a prespecified number, and will take on all subsequent discovery, development and commercialization work. Read More
Bad news has buffeted Sage Therapeutics Inc. twice in the past few months. Now its placebo-controlled phase II Lightwave study of dalzanemdor in Alzheimer's disease has missed the primary outcome measure, prompting the company to stop development of the NMDA receptor positive allosteric modulator in the indication. Read More
Stealth Biotherapeutics Inc. had hoped the U.S. FDA would have approved its lead candidate, elamipretide, as the first treatment for Barth syndrome by now. Instead, it’s headed to a meet-up with the agency’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) Oct. 10. The discussion and vote at that meeting could be make-or-break for patients with the ultra-rare debilitating mitochondrial disease that has no approved therapies. “Barring support from CRDAC, the future of elamipretide for Barth syndrome in the U.S. is tenuous," Stealth CEO Reenie McCarthy told BioWorld. Read More
David Baker, director of the Institute for Protein Design at the University of Washington School of Medicine, is a pioneer in protein design. His contributions have been recognized with countless awards, and now, a place among the 2024 Clarivate Citation Laureates. Baker’s lab has developed several open-source software applications for nanotechnology and biomedicine. With these methods, scientists build new proteins that bind to drug targets and block them or activate cellular signals. Read More
Wuhan YZY Biopharma Co. Ltd. is out-licensing lead candidate M-701, a CD3/EpCAM bispecific antibody, to Chia Tai Tianqing Pharmaceutical Group Co. Ltd. (CTTQ) for China rights in a deal worth up to $143 million. Under the deal, Sino Biopharmaceutical Ltd. subsidiary CTTQ is granted an exclusive license to develop, register, manufacture and commercialize M-701 within mainland China. Read More
It’s hard to know where to start in describing the biopharma applications of the 2024 Nobel Prize in Physics. It was awarded to John Hopfield and Geoffrey Hinton “for foundational discoveries and inventions that enable machine learning with artificial neural networks.” Read More
Gene and cell therapies will drive innovation for the next 10 years, Claus Zieler, the chief commercial officer at Astellas Pharma Inc., said in this episode of the BioWorld Insider podcast. Developers are on the cusp of breakthroughs because a gene can now be replaced “and that means we can potentially cure a disease rather than intervening in a disease.” Read More
Biopharmas raising money in public or private financings, including: Biovaxys, CK Life Sciences, Camp4, IMV, Rege Nephro, Upstream, Virios, Wex. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Astrazeneca, Avillion, Bergenbio, GE Healthcare, Hansa, Insignis, Johnson & Johnson, Kalvista, Scholar Rock. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: . Read More
