Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aadi, AB, Amryt, BMS, Gilead, Janssen, Neonmind, RDIF, Revive, Seqirus, Sterna, Tonix.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aligos, Astrocyte, Bluebird, Curative, Dragonfly, Evrys, Kancera, Marvel, Merck & Co., Qurient, Sellas, Simcere, Tonix, Vipergen.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aptevo, Dnatrix, Galapagos, Ocuphire, Oncotelic, Oramed, Santhera, Scynexis, Transgene.
Former FDA Commissioner Stephen Hahn is being asked to spill the beans on political interference at the U.S. agency during the emergence of COVID-19 last year.
The Pan American Health Organization is echoing fears that the COVID-19 pandemic will result in a surge of drug-resistant infections, saying surges already are being seen in several countries in the Americas, including Argentina, Ecuador, Guatemala, Paraguay and Uruguay.
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.”
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