No one will be sad to see the back of a horrendous year, with the raging pandemic bringing the world to its knees. However, the potential end to this dire situation is now tantalizingly in sight. The collective sigh of relief was certainly demonstrated by investors. According to Cowen & Co. analysts, “the sector had its strongest rally since the Spring and the biotech indices kept pace with the broader markets."
With the FDA perhaps days away from granting emergency use authorization (EUA) for the first U.S. COVID-19 vaccine, the Trump administration took a bow Dec. 8 at a summit called to celebrate what’s been accomplished and to explain what lies ahead in getting vaccines distributed throughout the country.
DUBLIN – Top-line data from a placebo-controlled phase II trial of Vicore Pharma Holding AB’s angiotensin II type two receptor agonist, C21, provide preliminary evidence that the oral drug may provide benefit to patients with severe COVID-19 disease on top of steroid therapy.
LONDON – The Oxford University team behind the development of Astrazeneca plc’s COVID-19 vaccine have become the first to publish full and complete interim phase III data in a peer-reviewed journal.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amgen, Beigene, Cerecor, Cyxone, Henlius, ITM, Ix, Takeda, Turning Point.
Brazilian health care regulator Anvisa has issued guidelines for SARS-CoV-2 vaccine manufacturers to receive emergency marketing approvals in the Latin American giant. Brazil is the largest market in the region and several COVID-19 vaccine makers are both doing trials there and hoping for quick approvals.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allogene, Alzecure, Antengene, Artiva, Chimerix, Immunicum, Kronos, Lipocine, Neuren, Novo Nordisk, Scpharmaceuticals, Scynexis, Sol-Gel, Viracta, Yiling.
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