Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Airiver, Becton Dickinson, Biomerica, Drug Farm, Hansa, Hemab, Pepgen, Perimeter.
Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: Bcworld, Carisma, Charles River, Daiichi Sankyo, Gaia, Grünenthal, Flo, Immunis, Imperial, Liberate, Nano-x, Novigenix, Oxipit, Sectra, Therna, Toray.
New hires and promotions in the biopharma and med-tech industries, including: Arcutis, Avalyn, Coloplast, Invivyd, Pacbio, Sanofi, Swarm, Tango, Vera, Xylocor, Zevra.
Perimeter Medical Imaging AI Inc. secured FDA premarket approval for Claire, its AI-powered imaging device which detects difficult-to-see cancer during breast-conserving surgery. Claire combines AI with wide-field optical coherence tomography to provide surgeons with high-resolution, real-time views of excised tumor margins, to reduce the need for re-operations.
Japan has approved the world’s first therapies derived from induced pluripotent stem cells (iPSCs), marking a major milestone for regenerative medicine and, potentially, a turning point in treating Parkinson’s disease.
The K-health MIRAE Initiative, also known as Korean ARPA-H, announced plans to allocate about ₩162 billion (US$110 million) in nine new projects over the next five years, with a focus on strengthening national health security.
One year on from establishing the baseline on female representation in the U.K. biotech industry, the latest survey shows the “dial is stuck.” Since the first report, representation at the CEO level has crept from 18.3% to 18.7%. That is “a marginal gain that signals a plateau at a time when we need a breakthrough,” said Jane Wall, managing director of the U.K. Bioindustry Association, which compiled the statistics.
RSS
