Italian family-owned Angelini Pharma SpA is making its first move into the U.S. market, acquiring rare diseases specialist Catalyst Pharma Inc. in an all-cash deal worth $4.1 billion. The acquisition gives Angelini ownership of three marketed drugs for treating epilepsy and neuromuscular diseases that had combined sales of $589 million in 2025, a 19.8% increase over 2024. Read More

Roche Holding AG has agreed to acquire Pathai Inc. for up to $1.05 billion in a bid to strengthen its position in digital pathology and enhance its biopharma services. The move builds on a partnership established between the two companies in 2021, and expanded in 2024, to include the development of AI-enabled companion diagnostic algorithms. Read More

A lower-than-expected increase in dystrophin over baseline in the first and lowest-dose cohort of a phase I/II study of ENTR-601-44 in Duchenne muscular dystrophy (DMD) caused shares of Entrada Therapeutics Inc. to plunge more than 57%, despite the cohort meeting the safety and tolerability primary objective. Read More

Hopes piqued last November for detalimogene voraplasmid in bladder cancer took a hit from the latest word from the study, as did shares of Engene Therapeutics Inc. (NASDAQ:ENGN), which closed May 7 at $1.72, down 80.6%, or $7.13. Read More

News of eight infections and three deaths so far due to an emerging zoonotic virus has brought back unhappy memories of the early days of SARS-CoV-2. At a press conference on Thursday, officials from the WHO did their best to calm the public’s fears that the MV Hondius, the ship currently heading to the Canary Islands with its remaining passengers plus assorted medical, WHO and European Center for Disease Prevention and Control staff, is the 2026 version of the Diamond Princess. Read More

Reports that Sanofi SA has asked to withdraw its sBLA for Tzield (teplizumab) from the U.S. FDA’s Commissioner’s National Priority Voucher (CNPV) program is once again raising questions about whether leadership skepticism is overruling approval decisions at the agency. Read More

Scientists at the La Jolla Institute for Immunology have identified and characterized human antibodies that neutralize the measles virus by blocking its entry into the cell. This is the first time that antibodies have been shown to bind effectively to two essential viral proteins, creating a dual blockade that prevents infection. Unlike the current vaccine, which is based on an attenuated virus and is not recommended for immunocompromised individuals, these monoclonal antibodies could be used both as a new vaccine approach and as a treatment for the entire population. Read More

Infectious disease-focused biopharma stocks, tracked on the BioWorld Infectious Disease Index (BIDI), saw their collective shares roughly follow the path of broader markets like the Nasdaq Biotechnology Index (NBI) and the Dow Jones Industrial Average (DJIA) in early 2026. The BIDI ended April up 3.8%, followed by the DJIA with a 3.31% gain and 2.73% for the NBI, following a similar pattern to 2025. Read More

Even before the U.S. FDA announced its one-day inspection pilot May 6, it already had test-flown 46 of the shorter inspections across several of its centers. Read More

Atara Biotherapeutics Inc.’s allogeneic T-cell immunotherapy, Ebvallo (tabelecleucel), for Epstein-Barr virus-positive post-transplant lymphoproliferative disease isn’t out of the running yet. Despite grim predictions in the wake of the U.S. FDA’s second complete response letter for the drug in January, Atara and partner Pierre Fabre Pharmaceuticals Inc. reached agreement with the regulator on a path for resubmitting the BLA. Read More

New hires and promotions in the biopharma and med-tech industries, including: Abli, Actuate, Anavex, Cellprothera, Cristcot, Cytora, Immutrin, Turbett Surgical. Read More

Biopharma and med-tech companies raising money in public or private financings, including: Aura, Avalo, Cellcentric, Citius Oncology, Inflarx, Kanvas, LTZ, Neurospectrum Insights, Signadori. Read More

Clinical updates for biopharma and med tech, including data readouts and publications: Aptevo, Atossa, Avalo, Bioxodes, Braintree, Cairn Surgical, Eupraxia, Helio Genomics, Hoth, Lytix, Medicus, Mingmed, Spago, Verrica. Read More

Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: Acea, Biontech, Boehringer Ingelheim, Deuteroncology, Eli Lilly, Epik, Halozyme, Lucent Diagnostics, Lunai Bioworks, Mannkind, Oncotelic, Oruka, Pathos AI, Phoenix Asia, Ribocure, Scilex Holding, Suzhou Ribo Life, Tempus AI, United Therapeutics. Read More

Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Artera, Bridgebio, Diakonos, Norgine, Nuvation. Read More