LONDON – The EMA has concluded that the rare cases of serious blood clots with low platelet counts seen after administration of Astrazeneca plc’s COVID-19 vaccine are caused by the vaccine, but said the benefits of its use continue to outweigh the risks. The possibility of cerebral venous sinus thrombosis and splanchnic vein thrombosis in the abdomen will now be listed as rare side effects and the EMA’s guidance to health care professionals will be updated.
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 hits company for deviations from drug, device GMPs; Stryker undertakes correction for AEDs; MHRA: Creams, ointments may interfere with CGM function; NICE says liver perfusion suffers for want of evidence of efficacy; NIAID testing vaccine allergy hypothesis; EC provides emergency funding for COVID-19 research; Medtronic splits Ninth Appeals’ review of lower court decision; Industry, docs push back on prior authorization.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bausch + Lomb, Chemence Medical, Nuvasive, Vitro Biopharma.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Applied DNA Sciences, Astrotech, Atai Life Sciences, Breathtech, Johnson & Johnson Vision, Manta, Medical Information Technology, Menicon, Natera, Newomics, Nicoya Lifesciences, Opsens, Psyber, Premier Medical, Qiagen, Roche, Titan Health & Security Technologies, Vizient.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acarix, Akili Interactive, Boston Scientific, Cardiac Dimensions, Lumithera, Medcura, Pixium Vision, Protokinetix.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aim, AVM, Bridge, Chinook, Daiichi Sankyo, Horizon, Recognify.
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.
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