LONDON - EMA Director General Guido Rasi has hit out at the lack of coordination in COVID-19 clinical trials, questioning if the huge number of small studies that are running will support regulatory decision-making.
Representing the highest amount ever raised by a public biopharma company on a U.S. exchange, Moderna Inc. priced a $1.34 billion follow-on offering to help fund worldwide manufacturing and distribution of its mRNA-1273 vaccine for COVID-19.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Kempharm, Novartis, Organicell, Theralase, Tolero.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Agios, Amplyx, Arbutus, Biogen, Covis, Hepion, Lidds, Mezzion, MGB Biopharma.
Moderna Inc.’s chief medical officer, Tal Zaks, said that the results in hand “give us great confidence that we've got the right dose range for phase III” work slated to begin this summer with COVID-19 vaccine prospect mRNA-1273. A regulatory filing could come as early as 2021.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adamis, Akebia, Astrazeneca, Biosig, BMS, Carsgen, Cyclo, Cytodyn, Daiichi, Genentech, Lidds, Nantkwest, Sellas, Teva, Vistagen.
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