Vera Therapeutics Inc. looks to get an almost five-month head start over a competitor, Vertex Pharmaceuticals Inc., as the U.S. FDA cleared its Trutakna (atacicept) as the first dual BAFF/APRIL inhibitor for treating immunoglobulin A nephropathy (IgAN). The accelerated approval, which came on the July 7 PDUFA date, indicates Trutakna for use in reducing proteinuria in adults with primary IgAN at risk for disease progression. The drug is administered once weekly via auto-injector. Read More
Representing the fourth largest biopharma M&A announced in 2026, Vertex Pharmaceuticals Inc. offered $85 per share in cash, or about $10 billion, to buy endocrine specialist Crinetics Pharmaceuticals Inc., adding the acromegaly drug Palsonify and a phase III asset, atumelnant, for congenital adrenocorticotropic hyperplasia (CAH). Read More
Tvardi Therapeutics Inc. rebounded from a phase II blowup last fall in idiopathic pulmonary fibrosis (IPF) with oral STAT3 inhibitor TTI-101 by showing that a next-gen phosphate prodrug dubbed TTI-109 kept its potency in phase I without gastrointestinal (GI) troubles. Read More
The gene therapy specialist formerly known as EG427 has a new name and fresh momentum, after closing a €33 million (US$37.7 million) series C that will further advance clinical development of the lead program in chronic neuro-urology indications. Read More
Opus Genetics Inc. has secured U.S. FDA alignment on an eight-patient phase III trial of its lead gene therapy, OPGx-LCA5, for an ultra-rare form of inherited childhood blindness. Read More
After years of hearings, finger-pointing and litigation, the U.S. Congress finally seems to be getting serious about fixing the 340B prescription drug discount program, which today is the second largest federal drug program. Read More
Separate research teams have reported new insights into resistance mechanisms to the antibody-drug conjugate (ADC) Padcev (enfortumab vedotin, Astellas Pharma Inc./Pfizer Inc.), and possibly to ADCs more broadly. Urothelial cancer drug Padcev, which targets the cell adhesion molecule Nectin-4, was approved in 2019 and is currently one of Pfizer’s top 10 medicines and vaccines, generating $1.94 billion in 2025. Read More
After decades of clinical research and false starts, have Brain-Computer Interface (BCI) systems finally arrived? With developments accelerating in the field, BioWorld's special series explores the advancements in the space, looking at the implanted technologies, their potential to transfer care, what’s driving investor interest and the challenges ahead. Read More
Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: Astex, Baiyunshan, Genentech, Incyte, Natera, Roche, Sanyou, Star, Tempramed, Vega. Read More
Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Ascelia, Forus, Invivyd, Median, Pharmaessentia, Pharvaris, Visby. Read More
