As of the end of January, SARS-CoV-2 has demonstrably infected more than 100 million individuals globally. It has killed more than 2 million. And the long-term sequelae of COVID infections – to say nothing of the health consequences of grief, social isolation and widespread economic distress – are still unfolding and will be for years to come.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Access Vascular, Braincool, Brainq, Cerus Endovascular, Genscript, Limacorporate, Roche, Techmah Medical.
LONDON – After a number of equivocal small studies, the U.K. Recovery trial has applied its heft to turn in statistically significant evidence that the rheumatoid arthritis treatment Roactemra (tocilizumab) reduces mortality in hospitalized COVID-19 patients.
Limited manufacturing capacity, supply chain disruptions and a dearth of personnel with specialized skills are all challenges vaccine makers are facing as they race to produce contracted quotas of COVID-19 vaccines that were developed and authorized in record time.
LONDON – The EMA has requested all COVID-19 vaccine developers to investigate if their products offer protection against new variants of SARS-CoV-2 and to submit the relevant data.
The latest global regulatory news, changes and updates affecting biopharma, including: Fed Circuit agrees Amgen patents lack enablement; HC nudging along with regulatory modernization plan; EMA: No Sputnik application yet.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Clinuvel, Genmab, Moderna, Oryzon, Polaryx, Seagen.
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