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. Read More
Regulus Therapeutics Inc. CEO Jay Hagan told investors in a January call the company had no interest in “simply out-licensing” rights to lead candidate farabursen, an oligonucleotide targeting autosomal dominant polycystic kidney disease set to start phase III testing on a path to a potential accelerated approval. And now, there’s no need to, as Regulus found a buyer for the whole company in a deal with Novartis AG valued at about $1.7 billion. Read More
If the April 30 hearing on biomedical research before the U.S. Senate Appropriations Committee is any indication, the Trump administration could face a big challenge if it tries to cut more than 40% of the NIH’s budget in fiscal 2026 as proposed and slap a 15% cap on indirect costs. Read More
Shanghai-based D3 Bio (Wuxi) Co. Ltd. showed positive results for its lead candidate, next-generation KRAS G12C inhibitor, D3S-001, also known as elisrasib, in patients with KRAS G12C mutation cancers, including patients previously treated with first-generation KRAS G12C inhibitors. Presented at the American Association for Cancer Research (AACR 2025) meeting on April 29, the data were simultaneously published in Nature Medicine. Read More
South Korea’s Ministry of Food and Drug Safety approved 18 biosimilar products in 2024, making it a record year for domestic biosimilar approvals since the agency’s first nod of Celltrion Inc.’s Remsima, a reference product of Remicade (infliximab), in 2012. Read More
The first 100 days of the Trump administration have been nothing short of chaotic, both in the U.S. and throughout the world. Shining a light through the uncertainty, BioWorld continues to cover the administration’s latest policy decisions and actions affecting the life sciences sector, as well as their impacts across the globe. It’s all right here at Trump administration impacts. Read More
BioWorld is pleased to begin providing a new quarterly dynamic table featuring new molecular entities (NMEs) revealed for the first time in current literature, at congresses and in company communications during the quarter. NMEs include compounds chosen for further pharmacological evaluation or as clinical candidates; new leads whose structural optimization could provide new therapeutic agents; new additions to the structural diversity of known mechanistic classes of drugs; and new pharmacological tools for investigating drug targets. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Agenus, Ankyra, Astrazeneca, Bayer, Cingulate, Coherus, Idorsia, Incyte, Novadip, Palatin , Puma, Relmada. Read More
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. Read More
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. Read More
