U.S. trading partners are raising concerns about the FDA’s continued delays in inspecting foreign drug manufacturing facilities due to the COVID-19 pandemic and related travel restrictions.
The Coalition for Epidemic Preparedness Innovations (CEPI) has agreed to provide Clover Biopharmaceuticals Ltd. with an additional $36.9 million to support development of SCB-2019, a recombinant trimeric Spike-protein subunit COVID-19 vaccine.
TORONTO – Despite high tech costs and tight public sector budgeting, COVID-19 has driven Canadian procurement offices to echo a sentiment uttered by average Canadians, “Damn the costs. Give us something that really works.”
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Axiology Labs, Biocept, Brain Scientific, Illumigyn, Imidex, Laurel Bridge, Lemon Medical, LOK, MGC, Nobel Biocare, Pathogendx, Peramare, Sprintray, Vela Diagnostics.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB Science, Antengene, Biogen, BMS, Gilead, Gracell, Moderna, Pfizer, Roche.
LONDON – Medical research charities that form an integral part of the U.K. health research system are still reeling from the impact of COVID-19 and now expect it will be three years before funding returns to pre-pandemic levels.
The FDA amended emergency use authorizations (EUAs) for the Moderna Inc. COVID-19 vaccine as well as the shot from Pfizer Inc. and Biontech SE. A single booster dose was green-lighted for people 18 years and older at least six months after finishing the primary regimen with either of the vaccines, or at least two months after getting the Johnson & Johnson shot.
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