Nearly a year after the SARS-CoV-2 virus first appeared in Wuhan, China, a ray of hope is shining on the world with high efficacy reported for four vaccines and U.S. emergency use authorizations granted to three more therapeutics.
The latest global regulatory news, changes and updates affecting biopharma, including: DEA gets on board with partial Rx fills; USPTO touts early results of amendment pilot; FDA posts combo product feedback final guidance.
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.
While med-tech deal values fall significantly short of last year, the 1,240 deals worth $4 billion recorded through November place 2020 above 2018 in terms of value and well above each of the last two years in terms of volume.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advaite, Airehealth, Rheonix.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acutus Medical, Biotronik, Canary Health Technologies, DDF, Durect, Eurofins, Evonik, Seaspine, Sherlock Biosciences, Smartshape Design.
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