Coronavirus Update: Japan Paxlovid Approval, US Lifts Covaxin IND Hold
Japan has added to its growing arsenal of COVID-19 treatments with the approval of the oral antiviral Paxlovid, while the US FDA has lifted a clinical hold on Bharat's vaccine, which has shown potential against Omicron. Also, Biological E's vaccine is approved for use in adolescents in India
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Xevudy, which was part of the deal, has already seen restrictions on its use due to diminished efficacy against Omicron. Plus, Ocugen is back in the game as the FDA has released the clinical hold on its Phase II/III vaccine trial, while Pfizer/BioNTech release new booster shot data for Comirnaty in children aged 6 months-5 years.
Shionogi announces plans to file for rapid Japan approval of S-217622, its once-daily oral therapeutic drug for COVID-19, while interim Phase III results show good efficacy for S-268019, its recombinant protein vaccine for SARS-CoV-2. Both are expected to be the first Japan-made solutions for the disease and could make a significant impact in the market.
Public Company Edition: As their stock prices plummet, Adagio reshuffles its research plan and names a new CEO, while Yumanity restructures and seeks strategic alternatives. Also, Bristol sells $6bn worth of notes, Amgen issues $750m green bond, and Inhibrx and Amryt amend and refinance debt.