Janssen Pharmaceuticals Inc.
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Panel expects to review five respiratory syncytial virus vaccines and vote on one or two of them in June 2023 and others four months later. Sanofi presents results of three clinical trials of its monoclonal antibody nirsevimab, which is on track to be the second RSV prophylaxis for infants.
Companies such as Novartis, Roche or Takeda are heavily invested in the advanced therapeutics field, usually spreading their bets across multiple modalities. The remaining challenges offer opportunities for the next wave of innovation to transform the field once again and make a dent in the larger market of common diseases and solid tumors.
Upcoming booster, adolescent data may be more commercially significant for the vaccine, which would enter a US market with few willing adults still unvaccinated. The tough prospects for one of the first COVID vaccines in development is a lesson in the importance of avoiding regulatory delays.
Now that multiple vaccines using different platforms seem to be associated with heart inflammation, the FDA and others want more data on whether a common characteristic of the virus or vaccine manufacturing is related.