Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aldeyra, Atara, Candel, GSK, Leo, Sprout, Verastem.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: 3Sbio, Bavarian Nordic, Gate Bioscience, Genentech, Eli Lilly, Kling Bio, Matchpoint, Novartis, Pfizer, Roche, Rocket, Sanofi, Verve.
In June 2025, BioWorld tracked 254 clinical trial updates across phases I to III, up from 223 in May, 151 in April and 197 in March. Of the June updates, 24 trials reported positive phase III results, while only one was reported as a failure.
Brandon Capital Partners Pty Ltd., Australia’s largest life sciences venture capital firm, announced the final close of its sixth fund at AU$439 million (US$288 million), the VC’s largest fund to date.
Memo Therapeutics AG is laying plans to advance its BK polyomavirus neutralizing monoclonal antibody potravitug into phase III development after reporting positive phase II results in treating infections in immunocompromised kidney transplant patients.
After a tough few weeks for Sarepta Therapeutics Inc., the EMA dealt another blow on July 25, announcing it will not be approving the Duchenne muscular dystrophy gene therapy Elevidys (delandistrogene moxeparvovec). Re-examination of the file led to a happier outcome for another drug that has attracted considerable controversy, Eli Lilly and Co. Inc.’s Kisunla (donanemab) for treating the early stages of Alzheimer’s disease.
Current treatments for Alzheimer’s disease have limited effects. While they can slow cognitive decline or alleviate symptoms, they do not reverse this complex neurodegenerative condition caused by multiple factors. Researchers from the Gladstone Institutes and the University of California, San Francisco (UCSF) have screened FDA-approved drugs in search of agents that could potentially modify the disease.
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