Moderna Inc. reached a milestone of sorts Jan. 31 as the U.S. FDA fully approved its COVID-19 vaccine, Spikevax (elasomeran), for use in adults. Meanwhile, the Moderna and Pfizer Inc.-Biontech SE vaccines are in the sights of the U.S. Congressional Progressive Caucus, which is pushing the Biden administration to do more to ensure global vaccination.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accord, Alx, Amryt, Beigene, Bioheng, Biontech, Blueprint, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Pfizer, Provention, Regeneron, Sanofi.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Dizal, GBT, Merck & Co., Pfizer, Sellas, Trevena.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bergenbio, Cognito, Cybin, Merck, MSN, Neurosense, Novavax, Nrx, Ostentus, PDS, Ridgeback, Vanda.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bioventix, Fluxion, FX Solutions, Materacor, Medtronic, Perceptive Solutions, Titan Medical.
While BioWorld’s Infectious Disease Index showed a huge 144% climb in 2020, an enthusiastic response toward defeating the SARS-CoV-2 virus, the index dropped significantly in early 2021 and spent most of the year spiking up and down, reacting abruptly to the promises of herd immunity and the threats of vaccine-resistant variants.
With phase Ib data published in The Lancet Microbe showing Suzhou Abogen Biosciences Co. Ltd.’s mRNA COVID-19 vaccine candidate ARCoV had acceptable safety and induced a strong immune response in the 120 people who received it, company partner Walvax Biotechnology Co. Ltd. is continuing to enroll participants in a large phase III test of the vaccine. If successful, the program could become the first of several Chinese-developed mRNA vaccines poised to take on the pandemic.
Pfizer Inc.’s oral antiviral Paxlovid (nirmatrelvir) COVID-19 antiviral looks set for approval in the European Union after it was given the green light by its top regulatory committee. The EMA’s Committee for Medicinal Products for Human Use recommended conditional marketing authorization for treatment of COVID-19 in adults who don’t require supplemental oxygen but are at increased risk for progressing to severe disease.
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