Biotech | January 22, 2022
Pfizer and OPKO update on the Biologics License Application for Somatrogon
Pfizer is evaluating the FDA’s comments and will work with the agency to determine an appropriate path forward
Pfizer is evaluating the FDA’s comments and will work with the agency to determine an appropriate path forward
Previously, the use of the drug was limited to patients requiring hospitalization
Go-ahead for pivotal clinical trial which is expected to commence by March
Phase 1/2 trial of E-602 expected to open in Q1 2022 in patients with solid tumours
Quviviq is a dual orexin receptor antagonist, which blocks the binding of the wake-promoting neuropeptides orexins and is thought to turn down overactive wakefulness, as opposed to treatments that generally sedate the brain
First launches expected in H1 2022
The global multi-center phase-II clinical trial will be a 36-week, multi-center, randomized, double-blind, placebo-controlled trial, followed by a 36-week open-label extension period
It is the first monoclonal antibody drug for use in any animal species
This surpasses the number of approvals supported in 2020
Novavax' vaccine has received authorizations of the vaccine in over 170 countries
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