→ Global Blood Therapeutics just got breakthrough therapy designation from the FDA for its all important sickle cell disease drug, voxelotor (GBT440). The decision was based on several clinical programs, including a PhI/II study in adults, an ongoing Ph2 trial in children, preliminary data from a PhIII study and compassionate access experience. The BTD will help expedite the review of voxelotor, which is now the sole drug in the pipeline for the newly public biotech $GBT.
→ Under a new commercial supply agreement, Boehringer Ingelheim’s facility in Shanghai will manufacture BeiGene’s $BGNE PD-1 inhibitor. Tislelizumab is the name of the monoclonal antibody, which is one of four lead assets developed by the biotech. It’s being tested, at different stages, both as a monotherapy and in combinations. “The agreement marks the first biopharmaceutical [Marketing Authorization Holder] trial project entering into commercial supply in China,” said Jiali Luo, general manager of Boehringer Ingelheim Biopharmaceuticals (China), referring to a pilot plan that allows for drug manufacturing to be outsourced in the country.
The best place to read Endpoints News? In your inbox.
Comprehensive daily news report for those who discover, develop, and market drugs. Join 41,800+ biopharma pros who read Endpoints News by email every day.Free Subscription