→ 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.
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