Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Adimab, Aicuris, Bavarian Nordic, Cumberland, Fertilai, Grifols, Mabwell, Medera, Royal Philips, Savara, Surgentec, Waiv.
Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: Aligos, Amgen, Amoytop, Astellas, Caredx, Cathether, Daiichi, Eurobio, Interna, Johnson & Johnson, Mabwell, Meiragtx, Sanofi, Vir.
Clinical updates for biopharma and med tech, including data readouts and publications: Acerand, Axena, Boehringer Ingelheim, Bold, Eli Lilly, Freya, Xvivo.
Biopharma and med-tech companies raising money in public or private financings, including: Achieve Life Sciences, Acurx, Adlai, Meiragtx, Onward, Pamdx.
New hires and promotions in the biopharma and med-tech industries, including: Achieve Life Sciences, Aktis, Araceli, Assureckd, Cubit, Envoy, Eton, Greywolf, Harbour, Helus, Juvisé, Neutrolis, Prime, Xilo.
As U.S. President Donald Trump’s third nominee for CDC director, Erica Schwartz will soon find out if three times really is a charm. Trump announced the nomination on social media April 16, touting Schwartz’s credentials for the job. Calling her “incredibly talented,” Trump cited her “distinguished career” as a military doctor, in the Navy and Coast Guard, and her service as deputy surgeon general during his first term in office.
Daiichi Sankyo. Co. Ltd. will begin a phased sale of its consumer health subsidiary, Daiichi Sankyo Healthcare Co. Ltd., to Suntory Holdings Ltd., as the Tokyo-based drugmaker sharpens its focus on oncology.
Delta-Fly Pharma Inc. is pressing ahead with discussions with the FDA for its lead acute myeloid leukemia (AML) candidate, radgocitabine (DFP-10917), despite a phase III miss on its primary endpoint, instead leaning on earlier-stage efficacy signals and emerging combination data to support a potential path toward conditional approval.
The ability of Ebenbuild GmbH’s digital twin technology to predict the deposition of inhaled drugs across the lungs has been validated in a study published in Nature Communications Medicine. The platform, which combines AI-driven image analysis and physics-based computational modeling, demonstrated strong agreement with in vivo imaging data across multiple inhalation scenarios.
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