LONDON – Results from two non-randomized phase I/II trials of the Russian COVID-19 vaccine Sputnik V that recently received conditional regulatory approval show both a frozen and a freeze-dried formulation of the two-shot vaccine had a good safety profile and induced antibody responses in all 76 participants within 21 days.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Arcturus, Bioaegis, Curevac, Nanoviricides, Organovo.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alligator, Amag, Ampio, Biontech, Blade, Crinetics, Hutchison China Meditech, Lexicon, Mesoblast, Oncopeptides, Relay, Savara.
While the emergency use authorization (EUA) the FDA granted Aug. 23 for convalescent plasma remains a political talking point, the agency moved ahead Sept. 2, issuing an updated, immediately effective guidance on the use of convalescent plasma to treat COVID-19 patients in ongoing clinical trials, on an expanded access basis or under the EUA.
LONDON – CEOs of five leading biopharma companies have hit back against any suggestion COVID-19 vaccines and therapies could be approved in advance of phase III data, saying it is imperative the highest standards of quality, safety and efficacy are upheld everywhere. The most important thing is to reinforce to the public the commitment to safety as the number one priority, said Kenneth Frazier, CEO of Merck & Co. Inc.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aeon, Cytodyn, Innovent, Nippon Shinyaku.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Allergy, AMRI, Astrazeneca, Biocryst, CNS, Deepvax, Diurnal, Enesi, Gilead, Geovax, Ionis, Pharnext, Redhill, Saliba, Vistagen, Xencor.
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