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.
It turns out that determining who gets a COVID-19 vaccine first can be nearly as challenging as developing the vaccine itself. The timeline is a big part of the challenge.
PERTH, Australia – Australia’s biopharma sector fared better than the country at large at the end of the financial year that ended June 30, as the country saw GDP fall 7% in the final quarter, the largest drop since 1959.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Dompé, Mesoblast, Mustang, Oblato, Pharmacyte.
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