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.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adamis, Assembly, Can-Fite, Connect, Inmune, Pfizer, Quantum, Quest, Takeda.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Amydis, Elekta, Element Materials Technology, Impact Analytical, Intelivation Technologies, Osso VR, Özyürek Mümessillik ve Dış Ticaret, Quidel, Somalogic, Thermo Fisher Scientific, Todos Medical.
LONDON – Conflicting data from around the world on the extent to which the Delta variant of SARS-CoV-2 is reducing the effectiveness of vaccines is generating uncertainty over the need, or not, for booster programs.
The Biden administration’s plan to roll out COVID-19 boosters by Sept. 20 could get pushed back – pending the outcome of an FDA advisory committee meeting and how quickly the FDA acts on the adcom’s recommendation. Peter Marks, director of the FDA's Center for Biologics Research and Evaluation, announced Sept. 1 that the agency will convene its Vaccines and Related Biological Products Advisory Committee for a virtual meeting Sept. 17.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Coherus, Entos, Harbour, Innovative Cellular, Janssen, Junshi, Medincell, Merck, Neuren, Teva.
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