"Now is the time to discuss the need for future boosters as we aim to move forward safely, with COVID-19 becoming a virus like others such as influenza that we prepare for, protect against and treat,” the FDA’s Peter Marks said in announcing an April 6 virtual meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC).
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Astrazeneca, Cstone, Kiora, Moderna, Sobi.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alladapt Immunotherapeutics, Astrazeneca, Biomarin, Clover, Codagenix, Dr. Reddy's, Eiger, Ionis, Journey Medical, Merck, Ose Immunotherapeutics, Promore, Resverlogix, Silence.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Amolyt, Aquestive, Bioheng, Heron, Inflarx, Moderna, TC, Tetra.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Akston, Beyondspring, Biolexis, Centogene, G1, Janssen, Moderna, Oppilotech, Protagonist, Prothena, Q Biomed, Respirex, Saerum, Werewolf.
Despite global drops in COVID-19 infections and because variants never rest, Eiger Biopharmaceuticals Inc. is taking its strong top-line phase III data of pegylated interferon lambda to global regulatory agencies for approval. The type III interferon that stimulates immune responses significantly reduced the risk of COVID-19-related hospitalizations or emergency room visits longer than six hours by 50% and death by 60%. The results prompted Eiger to say it would submit the data to the FDA for an emergency use authorization – and also to the EMA and Asian agencies – as soon as it could.
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