The fate of IL-33-targeting astegolimab will be determined by talks with regulators, after Roche AG’s Genentech unit rolled out mixed results from a pair of studies testing the compound vs. placebo on top of standard-of-care (SOC) maintenance therapy in subjects with moderate to very severe chronic obstructive pulmonary disease (COPD). Read More
Sarepta Therapeutics Inc. is declining a U.S. FDA request to voluntarily halt shipping its gene therapy, Elevidys (delandistrogene moxeparvovec), in the U.S. On July 18, Sarepta said had it received “an informal request” from the FDA to stop the shipments following a third patient’s death, tied to the gene therapy SRP-9004, which uses the same vector as Elevidys. Read More
Big pharma is increasingly shopping in China to fill its pipelines as it faces looming patent cliffs on major blockbusters coupled with growing pricing pressures on drugs. China’s out-licensing deals grew to represent 32% of global deals in the first half of 2025, according to a Jefferies report on China dealmaking. Read More
After two decades of research elucidating the basic science, Tafalgie Therapeutics SA has delivered the first clinical data for its non-opioid analgesic. Read More
SML Biopharm Co. Ltd. is harnessing mRNA technology to develop novel immunotherapy-based cancer vaccines, including two candidates for cervical and head and neck cancers caused by human papillomavirus (HPV) infection. Read More
Despite Health and Human Services Secretary Robert Kennedy’s oft-repeated vow to rid the FDA of industry influence, FDA Commissioner Marty Makary announced George Tidmarsh, an industry veteran, will be the next director of the agency’s Center for Drug Evaluation and Research (CDER). Read More
There is still no effective vaccine or cure for HIV. Scientists are considering options ranging from longer-term antiretroviral therapy (ART) that space out injections by several years to long-lasting pre-exposure prophylaxis (PrEP) that acts as a vaccine while immunization is achieved. What else can be done? Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Cantargia, Bristol Meyers Squibb, Viatris. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Blueprint Medicines, Hekabio, Nkgen, Sanofi. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ARS, Imcheck, Knight, Novartis. Read More
