Asia

I-Mab announced positive interim data from its U.S. Phase II/III clinical trial of plonmarlimab for treatment of cytokine release syndrome in severe COVID-19.
Oyster Point Pharma inked a license and collaboration deal with Ji Xing Pharmaceuticals to develop and market OC-01 (varenicline) and OC-02 (simpinicline) nasal sprays for dry eye disease in Great China.
U.S. authorization is likely not a priority for Novavax since half the population is already vaccinated. But with other parts of the world, there’s still plenty of room for a Novavax vaccine.
Biopharma and life sciences companies from across the globe provide updates to their pipelines and businesses.
Collaborating with Frazier Healthcare Partners, the team spun out a new company dubbed HilleVax to take Takeda’s norovirus vaccine into Phase 3 trials.
The U.S. Securities and Exchange Commission has halted registrations of U.S. initial public offerings (IPOs) by Chinese companies.
Three major pharmaceutical and biotechnology companies announce the success of their respective funding rounds to support future efforts.
FDA
Semglee was approved under the FDA’s 351(k) pathway, a biologics license application process. It ensures that the bio similarity is based on animal studies, clinical trials, and analytical studies.
Biopharma and life sciences companies from across the globe provide updates on their pipelines and business operations including Takeda, Origin Therapeutics, ERS Genomics and more.
Moderna continues to assess its COVID-19 vaccine in juveniles, the company is expanding the study to include protocols to detect the potential of rare side effects, including heart inflammation.
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