Barely a year after the U.S. FDA shackled Abeona Therapeutics Inc.’s cell-based gene therapy with a complete response letter, the agency has approved it for treating a rare and genetic skin disease. Zevaskyn (prademagene zamikeracel), for treating wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa, will be priced in the U.S. at $3.1 million. Read More
Stealth Biotherapeutics Inc., and, more importantly, patients with Barth syndrome, faced another disappointing delay April 29 when the U.S. FDA kicked its approval decision down the road for Stealth’s elamipretide. Read More
Another complete response letter from the U.S. FDA for Regeneron Pharmaceuticals Inc.’s age-related macular degeneration (AMD) therapy Eylea (aflibercept) – along with disappointing sales of the VEGF inhibitor – dented shares (NASDAQ:REGN) by $41.95. They closed April 29 at $568.91, having traded as low as $542.44 during the day. Read More
Off-the-shelf cancer vaccine specialist Nouscom AG announced positive final results for its lead product, Nous-209, showing there was a “highly potent” and durable immune response in carriers of Lynch syndrome, a common hereditary condition that can increase the lifetime risk of cancer by as much as 80%. The data, presented at the annual American Association for Cancer Research meeting on April 29, indicate Nous-209 elicits a cancer-preventing effect. Read More
“I think we’ve come a long way in understanding the importance of this biology. We know it affects men and women, children and adults,” Paul Mischel told the audience during his plenary talk at the 2025 Annual Meeting of the American Association for Cancer Research (AACR 2025). “It’s very prevalent, it’s very devastating. It creates resistance. And we’ve learned some very fundamental rules about this biology that are driving it.” Read More
Orum Therapeutics Inc. on April 26 pulled the plug on a U.S.-based phase I study of ORM-5029, its lead oncology degrader antibody conjugate (DAC) asset, a decision that came months after the company first reported a patient death in November 2024. Read More
Ono Pharmaceutical Co. Ltd. terminated development of CTX-177 (ONO-7018), its ex-oncology candidate in-licensed from Chordia Therapeutics Inc. in December 2020 for up to ¥52.9 billion (US$370.37 million). Read More
With April 29 being Day 100 for U.S. President Donald Trump, his staff observed the day by touting the achievements of the administration’s first 100 days in office, especially new commitments made by the private sector to invest more than $5 trillion in U.S.-based manufacturing, R&D, infrastructure and technology. 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
New hires and promotions in the biopharma industry, including: Aavantgarde, Adagene, Crescent Biopharma, Hervolution, Montai, Nocion, Scholar Rock, Secarna. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Akeso, Alterity, Boehringer, CG Oncology, Chemomab, Immunitybio, J&J, Levicept, Merck, Oncoinvent, Pfizer, Revolution, Senti, Urogen, Yoltech. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ante, Galmed, Ferrer, Formosa, Laboratorios Saval, Medicus, Octagon, Prilenia, Spruce. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alnylam, Argenx, Bridgebio, Camurus, Eton, Halozyme, Innorna, Innovent, Italfarmaco, Jazz , Junshi, PTC, Purespring, Regeneron, Telix, Valneva. Read More
