Vertex Pharmaceuticals Inc. is on track to complete a BLA by the end of March seeking potential U.S. accelerated approval for povetacicept, its dual inhibitor of the BAFF and APRIL cytokines, to treat immunoglobulin A nephropathy (IgAN), following a successful phase III Rainier trial. Read More
Fast on the heels of the U.S. FDA’s go-ahead regarding the expanded use of Wellcovorin (leucovorin) tablets for cerebral folate deficiency in adult and pediatric patients with a confirmed variant in the folate receptor 1 gene – some of whom bear “autistic features” as part of their condition – the American Academy of Pediatrics advised against giving the drug to children with autism spectrum disorder. Read More
Twelve years on from the World Health Organization formally raising the alarm, antimicrobial resistance continues to grow, and despite numerous public and private incentives and initiatives, the pipeline of antibiotics in development is thinner than ever. Read More
In releasing its latest revision of a draft guidance on biosimilars and interchangeable biosimilars, the U.S. FDA took another step in streamlining the development of the follow-ons by easing unnecessary clinical pharmacokinetic testing involving comparator biologics approved outside the U.S. Read More
Medtronic plc has agreed to buy Scientia Vascular Inc. for $550 million, as it makes good on its promise to embark on more strategic acquisitions this year. The acquisition will bolster its neurovascular business as it adds a portfolio of guidewires and catheters, which uses Scientia’s microfabrication technology to simplify complex neurovascular procedures. Read More
Med-tech financings totaled $6.08 billion in the first two months of 2026, slightly below the $6.31 billion raised in January to February 2025, a year-over-year decline of about 4%. Even so, the early 2026 total remains well above the openings seen in 2020 ($5.61 billion), 2022 ($4.36 billion), 2023 ($1.67 billion) and 2024 ($4.66 billion). Read More
Australia’s Telix Pharmaceuticals Ltd. is advancing a potential challenger to Novartis plc’s dominant prostate cancer radioligand therapy, Pluvicto (lutetium [177Lu] vipivotide tetraxetan), after reporting that the safety lead-in portion of its global phase III Prostact trial met its primary objectives. Read More
Rapport Therapeutics Inc. added $20 million to its cash runway for its lead phase III oral seizure drug, RAP-219, through a potential $328 million license deal signed with Tenacia Biotechnology Co. Ltd. Read More
If one could sweep the brain clean and send the toxic substances that drive neurodegeneration to the recycling bin, perhaps one could treat Alzheimer’s disease. Researchers at the Chinese Academy of Sciences propose a new therapeutic strategy that uses synthetic peptides that bind to amyloid-β (Aβ) and direct it toward lysosomes. In addition, researchers at the Washington University School of Medicine in St. Louis have genetically modified astrocytes in vivo to express chimeric antigen receptors (CARs) that recognize and phagocytose Aβ plaques. Read More
The U.S. FDA released an early alert March 10 regarding the rupturing or bursting of certain Erbe USA Cryoprobes when they’re activated. Meanwhile, the company is voluntarily recalling the affected Erbe Flexible Cryoprobes, which use extreme cold and cryoadhesion for procedures such as the removal of blood clots, necrotic tissue, and tissue tumors and biopsies. Read More
Biopharma and med-tech companies raising money in public or private financings, including: AN2, Defence, Invea, Korro, Lyell, Relmada, SS Innovations, Telo Genomics. Read More
Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: Actuate, Baymedica, DT-Axis, Eledon, Etcembly, Fujitsu, Galecto, Inmed, Kuva Labs, Kyron.bio, Lisata, Newcelx, Servier, Zelluna. Read More
Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Astrazeneca, BMS, Chiesi, Claritas, Daiichi, Immunitybio, Incyte, Johnson & Johnson, Junshi, MBX, Nanosonics, PMV, Precision, Protalix, Sangamo, Savara. Read More
