Among regulatory news of note, China’s BeiGene gained its first drug approval on its domestic market, that of tislelizumab for Hodgkin’s lymphoma. M&A events saw Swiss pharma giant Roche finally gain clearance from competition authorities to close its $4.3 billion acquisition of gene therapy developed Spark Therapeutics. On the research front, Axsome Therapeutics last week released positive results for its migraine drug candidate AXS-07. It also has an interesting depression drug candidate in development. But there was disappointment for Incyte with the failure of its Phase III itacitinib trial in graft versus host disease.
On Friday evening (12/27), BeiGene announced that the China National Medical Products Administration (NMPA) had approved the company's anti-PD-1 antibody tislelizumab for the treatment of patients with classical Hodgkin's lymphoma (cHL) who have received at least two prior therapies. The NDA had been granted priority review, and approval was expected before year end 2019. This is BeiGene's first internally discovered drug approved in China, noted SVB Leerink Research analyst Andrew Berens.
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