Japan’s Ministry of Health, Labour and Welfare approved Taiho Pharmaceutical Co. Ltd.’s Lytgobi (futibatinib) for unresectable biliary tract cancer harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions that has progressed after chemotherapy.
Japan’s Pharmaceutical and Medical Devices Agency has cleared Healios K.K. and Sumitomo Pharma Co. Ltd. to begin a phase I/II study of HLCR-011, which is composed of retinal pigment epithelial (RPE) cells derived from allogeneic induced pluripotent stem cells (iPS) in patients with RPE tear.
Enveric Biosciences Inc. is gearing up to begin clinical trials in generalized anxiety disorder with lead candidate, EB-373, a psilocin prodrug. Trials are expected to begin in the fourth quarter of 2023.
Telix Pharmaceuticals Ltd. will acquire Lightpoint Medical Ltd. in a $35 million deal that will expand its urology pipeline and bring in house a new surgery-focused unit. Under the terms of the deal, Telix of Melbourne, Australia, will pay Lightpoint $20 million up front and a further $15 million on achievement of certain development milestones. The up-front payment will be paid in equity, and the additional milestones will be payable in cash or equity, at Telix’s election.
Shionogi & Co. Ltd.’s U.S. subsidiary Shinogi Inc. will acquire San Diego-based Qpex Biopharma Inc. in a deal worth up to $140 million that expands Shionogi’s pipeline of infectious disease agents and also adds to Brii Biosciences Ltd.’s pipeline.
Shionogi & Co. Ltd.’s U.S. subsidiary Shinogi Inc. will acquire San Diego-based Qpex Biopharma Inc. in a deal worth up to $140 million that expands Shionogi’s pipeline of infectious disease agents and also adds to Brii Biosciences Ltd.’s pipeline.
Japan’s Pharmaceutical and Medical Devices Agency has cleared Healios K.K. and Sumitomo Pharma Co. Ltd. to begin a phase I/II study of HLCR-011, which is composed of retinal pigment epithelial (RPE) cells derived from allogeneic induced pluripotent stem cells (iPS) in patients with RPE tear.
Enveric Biosciences Inc. is gearing up to begin clinical trials in generalized anxiety disorder with lead candidate, EB-373, a psilocin prodrug. Trials are expected to begin in the fourth quarter of 2023.
Telix Pharmaceuticals Ltd. will acquire Lightpoint Medical Ltd. in a $35 million deal that will expand its urology pipeline and bring in house a new surgery-focused unit. Under the terms of the deal, Telix of Melbourne, Australia, will pay Lightpoint $20 million up front and a further $15 million on achievement of certain development milestones. The up-front payment will be paid in equity, and the additional milestones will be payable in cash or equity, at Telix’s election.
In its second approval this month from the U.S. FDA, Avita Medical Inc.’s Recell system received premarket approval for the repigmentation of stable depigmented vitiligo lesions. The approval marks the first therapeutic device offering a one-time treatment for vitiligo at the point of care. Using the device, a clinician prepares and delivers autologous skin cells from pigmented skin to stable depigmented areas.
