Clinical results offered at the recent meeting of the American Urological Association in Las Vegas signal that better treatments may lie ahead for non-muscle invasive bladder cancer.
Dimerix Ltd. sealed an exclusive license agreement with Amicus Therapeutics Inc. for commercialization of its phase III kidney disease candidate, DMX-200, in a deal valued at AU$940 million (US$601.22 million).
“We are prepared for every scenario, even though we don’t know what some of those are.” That sums up the message from executives of Astrazeneca plc, GSK plc and Sanofi SA, when quizzed during presentations of their first-quarter 2025 results this week, about the fallout if pharmaceuticals they import to the U.S. are subject to tariffs.
Less than a week after announcing it had a new CEO, privately held Creyon Bio Inc. began a licensing and research partnership with Eli Lilly and Co. Creyon is getting $13 million up front and could bring in more than $1 billion in milestone payments. The two plan to find, develop and commercialize RNA-targeted oligonucleotide treatments for a range of diseases.
The Trump administration’s broad slash to university research budgets raises pertinent questions over impacts to the biopharma ecosystem, specifically how a changed trajectory of early research programs will affect tomorrow’s treatments and cures. Who is going to bridge research from idea to company if grants from the U.S. NIH are no longer an option?
The U.S. FDA approval of Johnson & Johnson’s Imaavy (nipocalimab-aahu) for myasthenia gravis brings the monoclonal antibody into a treatment space that teems with competition, both approved and in-development candidates. The human Fc receptor inhibitor was approved to treat generalized myasthenia gravis in patients who are 12 years and older. Patients must be anti-acetylcholine receptor [AChR] or anti-muscle-specific kinase [MuSK] antibody positive. Anti-AChR and anti-MuSK antibody-positive individuals make up more than 90% of all antibody-positive gMG patients.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Abeona, Astrazeneca, Bioinvent, Cosmo, CSL, Incyclix, Shorla, Stealth Bio, Telix, Travere.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alpha Anomeric, Alpharose, Charles River Laboratories, Granata, Innosign, Medigene, Oviva, Revelation, Scipher, Vaxart.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Agenus, Ankyra, Astrazeneca, Bayer, Cingulate, Coherus, Idorsia, Incyte, Novadip, Palatin , Puma, Relmada.
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