Japan Nod Positive For Hemlibra But Shadows Linger
Japan has become the third major market after the US and EU to approve Chugai’s novel antibody Hemlibra (emicizumab) for hemophilia, adding another building block for what the company hopes will become a major international growth driver, but some uncertainties remain.
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News of the deaths, which included patients using Hemlibra for compassionate use and in clinical trials, has put the drug's safety profile in the spotlight again even though Roche has pointed out investigators have stated that the causes of death were unrelated to the recently-approved hemophilia A therapy.
Shire explains why it is seeking preliminary injunction against Genentech; National Hemophilia Foundation and Hemophilia Federation of America decline to take position on dispute.