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Latest From Ocugen Inc.
With the world’s first exclusively intranasal COVID-19 vaccine against COVID-19 getting restricted use approval in India, Bharat Biotech/Washington University St. Louis offer an easy-to-use immunization option. But is it too little too late?
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.
Updated guidance says variant-directed vaccines should demonstrate statistically superiority to the prototype vaccine in a comparison of geometric mean titers against the particular variant of concern; seroresponse rates can be assessed on the basis of either noninferiority or superiority.
Apart from assuming that its new drug will always be a blockbuster, the other common mistake made by biotech companies and investors is that there will invariably be a viable market for its drug. The competition will have other ideas.
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- Histogenics Corporation