Coronavirus Update: Once Written Off, Roche's Actemra Finally Gets EUA In COVID-19
Plus mRNA Vaccines To Carry Myocarditis Warning
Actemra finally gains an emergency use authorization, Lilly's antibodies withdrawn again amid Delta variant concerns, plus Latin America’s belief in an anti-parasite drug in COVID-19 could soon be punctured.
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The company is assessing a potential path forward in COVID-19 for the drug and is in talks with platform study groups after a Phase III study did not show statistical significance, but still showed activity.
Coronavirus Update: As Pfizer/BioNTech Begin Omicron Vaccine Tests, Regulators Want To Explore Multivalent Route
Pfizer explores options for new vaccine update, Veklury expands to non-hospitalized patients but Regeneron and Lilly therapies stopped in face of Omicron efficacy drop-off.
CAR-T cell immunotherapies can be administered when only one dose of Roche's Actemra is available on-site for each patient, rather than two doses required under REMS for the immunotherapies. The change is one of the few pandemic-related REMS revisions that has been made public.