Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alpha Cognition, Ascletis, Biomarin, Cormedix, Gensight, Global Blood, JW, Merck & Co., Moderna, RDIF, Underdog, Versantis.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adaptimmune, Alnylam, Candel, Horizon, Inversago, Knopp, Lexaria, Newron, Onquality, Pliant, Redhill, Servier, Sobi, Trisalus, United, Valbiotis, Zynerba.
Eyegene Inc. has received the green light from South Korea’s Ministry of Food and Drug Safety (MFDS) for EG-COVID, its mRNA COVID-19 vaccine, to enter the clinic. Eyegene will now begin a phase I/IIa trial, to be conducted in two stages, to evaluate the vaccine’s safety, tolerability and immunogenicity.
PERTH, Australia – On the heels of a A$90 million (US$67.12 million) initial public offering on the Australian Securities Exchange, device company Trajan Group Holdings Ltd. has doubled its share price and is well poised for its next stage of global growth. Trajan makes precision consumable products, devices and solutions that used in analyzing biological samples.
While the volume of regulatory data is above this point last year by more than 17%, the proportion of COVID-19-related news is nearly the same, as is the number of U.S.-approved new molecular entities (NMEs).
The European Commission and Astrazeneca plc have ended their legal row over COVID-19 vaccines, while also reaching an agreement over supplies of remaining shots to Europe. The settlement brings to an end an unseemly row over vaccine supply, which further soured relations between the EU and U.K. following Brexit.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beigene, Cstone, Eqrx, Evgen, Kahr, Moderna, Novartis, Orphalan, Pfizer, Polaryx, Relief, TCR2, Tetra.
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