The latest global regulatory news, changes and updates affecting biopharma, including: EC provides emergency funding for COVID-19 research; Final judgment against former Retrophin attorney; FDA hits company for deviations from drug, device GMPs.
LONDON – The largest study to date, involving 236,379 confirmed cases, shows that 1 in 3 survivors of COVID-19 was diagnosed with a neurological or psychiatric condition within six months of contracting the infection. For 13% of those patients, it was their first such diagnosis.
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.
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