The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA adds fingerstick sample to roster of COVID EUAs; NICE: Sonata system not backed by head-to-head studies.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Philips, Roche.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abcam, Avacta, Applied Spectral Imaging, Biotome, Brainchip, Critical Transport Solutions Australia, Cryoport, Eurofins Viacor, Heartflow, Kromatid, Masimo, Motus GI, Novel Microdevices, Oncimmune, Ortho Regenerative Technologies, Roche.
Plans for a late-stage test of Valneva SE's COVID-19 vaccine candidate, clinical progress on a different vaccine from Novavax Inc. and advancement for two midstage therapies targeting the virus made clear April 6 that industry efforts to battle the pandemic remain in high gear.
The European Commission opened a public consultation to help it develop the Health Emergency Preparedness and Response Authority, a new initiative to better prepare Europe for cross-border health threats.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: AB Science, Amarin, Ampio, Ani, Boehringer, Catalent, Checkmate, Hoth, Janssen, Kuros, Ionis, Maxwell, Moderna, Ose, Oryzon, Oxford Biomedica, Progenity, Rational Vaccines, Valeo, Yumanity.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Baebies, Compleware, Cyduct, Dexcom, Eyekor, Welldoc.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 89bio, Abbvie, Acadia, Exelixis, Eli Lilly, Passage, Supernus, Tetra.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acea, Advaxis, Amneal, Anixa, Can-Fite, Chinook, Emergent, Johnson & Johnson, Kashiv, Ontochem, Panacea, Sairopa, Sorrento, Teneobio, Vir, Virpax.