Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aldeyra, Cellectis, Cybrexa, Diffusion, Endo, Mallinckrodt, Neurogene, Novartis, Otonomy, Otsuka, Propeller, Senhwa, Sosei.
Missing the primary endpoint along with key secondary endpoints in a phase III trial of Kevzara (sarilumab), an interleukin-6 (IL-6) receptor antibody, for treating COVID-19 patients who need mechanical ventilation caused Regeneron Pharmaceuticals Inc. and Sanofi SA to halt the study.
A large epidemiological study published in the July 6, 2020, advance online issue of The Lancet found that most individuals who became infected with SARS-CoV-2 developed antibodies to the virus, confirming that infection usually results in at least a short-term immune response.
DUBLIN – Even by any normal measure of European biotechnology investment, the first two quarters of 2020 were memorable. If it maintains the present momentum, Europe’s drug development sector is on course for a record-breaking year, having already raised $5.034 billion in publicly disclosed equity investments. That puts it well ahead of any other year – the sector edged to a new high in 2019 when it raised $7.739 billion over the full 12 months – but, of course, comparisons with any other year seem irrelevant. This year is like no other. The COVID-19 pandemic has changed everything.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Aetna, Arrow International, BD, Erba Diagnostics, Eternity Healthcare.
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