DBV Technologies SA CEO Daniel Tasse said his firm will meet “very shortly” with the U.S. FDA for talks that will formalize an accelerated approval process for the Viaskin Peanut allergy patch. “Did this take longer than expected? Yes, it did,” Tasse said during a conference call update. “But this was a choice we made, and it was a necessary choice” in order to nail down precise requirements for the product.
Despite positive findings from an earlier trial, Alto Neuroscience Inc.’s BDNF-targeting candidate, ALTO-100, failed to best placebo in a phase IIb study in major depressive disorder, sending shares of the company to their lowest price since going public in a February 2024 IPO, as investors worried about readthrough to Alto’s biomarker-based approach for treating psychiatric disorders.
Modifi Biosciences Inc. has come a long way very quickly. Spun out of Yale University in 2021, it published data on DNA in Science in July 2022, and now it’s being acquired by Merck & Co. Inc. for $30 million up front. Ultimately, Modifi shareholders could receive milestones of up to $1.3 billion.
The U.K. Medicines and Healthcare products Agency has become the third to approve Eli Lilly and Co.’s Kisunla (donanemab), but the drug’s spending watchdog has simultaneously ruled the Alzheimer’s disease treatment is not cost effective.
The U.K.'s Medicines and Health Care Products Regulatory Agency (MHRA) has posted a series of draft new regulations that will increase the requirements for device makers doing business in the U.K. However, the agency has also floated a regulation for the production of pharmaceuticals at the point of care, a proposal MHRA said is the first of its kind.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alvotech, Camurus, Nido, Remedy, Sangamo, Teva.
New hires and promotions in the biopharma industry, including: Alphina, Apnimed, Arialys, Artiva, Disc Medicine, Flagship Pioneering, Kenai, Klotho, Ligachem.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bioversys, Editas, Genentech, Genevant, Grifols, Johnson & Johnson, Moderna, Nucleome, Rectify, Rhine Pharma, Telix, UCB, Zylem.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Annexon, Briacell, Clearside, Everest, Immunic, Minghui, Monopar, Oncternal, Otsuka, Quell.
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