Indicating its continuing strategy to invest in antibody-drug conjugates (ADCs), Astrazeneca plc obtained exclusive global rights to Claudin 18.2 ADC CMG-901 from Keymed Biosciences Inc. and Lepu Biopharma Co. Ltd. in a deal worth up to $1.163 billion. Read More
The U.S. FDA has approved the priority BLA for Sanofi SA’s hemophilia A treatment nearly a week before its Feb. 28 PDUFA date. The approval is for efanesoctocog alfa, a recombinant factor VIII (rFVIII) therapy – the company has managed to partially incorporate rFVIII into the drug’s brand name, Altuviiio. The price per dose was not released by the company. Read More
Antibody specialist Jounce Therapeutics Inc. and Redx Pharma plc are to merge in an all-share transaction with a value of $425 million, in a deal that will see Redx’s small-molecule cancer and fibrosis drugs absorbing the lion’s share of the combined cash and its shareholders owning 63% of the combined company. Read More
Aiming to start afresh under a new name, troubled Mei Pharma Inc. wants to merge with Infinity Pharmaceuticals Inc. in an all-stock transaction that would provide the combined outfit enough cash to fund operations through mid-2025. Specifically, coffers of the newly made firm would contain about $100 million for the advancement of three oncology candidates in a pipeline led by Infinity’s phase II-stage eganelisib for head and neck squamous cell carcinoma. Read More
In the larger picture, the fight against HIV has been a triumph of modern medicine. A patient diagnosed with HIV in the 1980s had a remaining life expectancy of 1 to 2 years. In 2023, they can expect to live another half century. But so far, an HIV vaccine has remained elusive. In the newest phase III failure, Janssen Pharmaceutical Cos. of Johnson & Johnson closed down its Mosaico trial more than a year ahead of schedule, following a data and safety monitoring board’s (DSMB) report saying the study was not expected to hit its primary endpoint. Read More
Despite pleas from patient advocacy groups and bipartisan pressure from the U.S. Congress, the Centers for Medicare & Medicaid Services (CMS) isn’t budging on its national coverage determination for amyloid-targeting monoclonal antibodies approved to treat Alzheimer’s. Read More
Radiopharmaceutical company Fusion Pharmaceuticals Inc. is acquiring a phase II actinium-based alpha-emitter radiopharma program for prostate cancer from Radiomedix Inc. Read More
As James Peyer, the CEO of Cambrian Biopharma Inc., watched his grandfather fail every cancer treatment and pass away, he also saw the structure of his future company being born. Waiting until people became sick was the wrong way to treat disease, he found. Instead, Cambrian was created to develop anti-aging therapies, a unique business model that fits the new field of geroscience. To do that, Cambrian became a biotech business, a VC fund and an incubator. Peyer spoke to the BioWorld Insider Podcast about his pipeline and how he goes about fundraising in a little understood field. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alteogen, Biomx, Corium, Dare, Grid, Immunic, Immunocore, Jaguar, Kinnate, Linkinvax, Merck & Co., Modus, Shionogi. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Albireo, Brain, Cue, Elevatebio, Eterna, Fatiabgen, Ferrer, Gilead, GRDG, Heron, Impact, Ipsen, Kempharm, Kinnate, Kinnjiu, Kite, Life Edit, Lineage, Moderna, NRG, Ordaōs, Tmunity, Transcode and Zevra. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adial, Alimera, Cognition, Erydel, Fapon, GSK, Pfizer, PTC, Sage, Seagen, Viiv, Vir. Read More
