Minoryx Therapeutics SL is banking what it described as “a significant double-digit up-front payment” and could earn up to €258 million (US$262.1 million) more in milestone payments and development funding from a license agreement with Neuraxpharm GmbH, which covers European rights to its lead drug candidate, leriglitazone, in central nervous system indications. It will also receive tiered double-digit royalties on product sales. Read More
In addition to the Medicare inflation rebate and the other pricing reforms of the Inflation Reduction Act, manufacturers of certain Part B drugs will be subject to a refund provision tucked away in the Infrastructure Investment and Jobs Act that was signed into U.S. law last year. Read More
Newco Breye Therapeutics ApS is poised to repurpose an intravenously administered drug that failed in ischemia reperfusion injury as an orally available treatment for diabetic retinopathy, after closing a €4 million (US$4.1 million) seed round. Read More
The U.S. FDA hit a Phoenix-based Abraxis Biosciences LLC facility with a warning letter citing out-of-control aseptic manufacturing processes for Abraxane (paclitaxel), a key chemotherapy drug. The letter, posted Nov. 8, noted that multiple media fill failures occurred last year during simulated aseptic processing operations on the Abraxane filling line. Read More
Fresh off announcing a new $1.2 billion joint drug discovery and development project with Sanofi SA, Insilico Medicine Inc. founder and CEO Alex Zhavoronkov joined a chorus of executives at the Asia Summit on Global Health in proclaiming the critical importance of partnership between biopharma, tech companies, and regulators, even amid rising tensions between China and the West. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Allysta, Ambrx, Atyr, Beckley, Chemomab, Clearside, Dynamicure, Enanta, Flugen, Inflarx, Meissa, Merrimack, Revolo Trevena. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acuitas, Astrazeneca, Biocryst, Enterobiotix, Geovax, Imaginab, Imunon, Kindeva, Orange, Parthenon, Viatris. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Biomebank, Eikonoklastes, Nfl, Novartis, Oryzon, Regeneron, Xilio. Read More
