Top-line results show a disappointing placebo effect that resulted in Sumitomo Pharma Co. Ltd./Otsuka Pharmaceutical Co. Ltd.’s ulotaront (SEP-363856) missing the primary endpoints in both the Diamond (Developing Innovative Approaches for Mental Disorders) 1 and Diamond 2 trials in schizophrenia.
Kissei Pharmaceutical Co. Ltd. has withdrawn its NDA in Japan for rovatirelin (KPS-0373) for the treatment of spinocerebellar degeneration. Kissei, of Osaka, Japan, said it temporarily withdrew the application for marketing approval and would discuss the possibility of conducting additional clinical trials with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), because the PMDA expressed concern about the approval based on the current clinical trial data.
Sosei Heptares is fulfilling its ambition for growth in the Asia-Pacific region by buying the Japanese and South Korea businesses of Swiss biotech Idorsia Ltd. for ¥65 billion (US$463 million), potentially freeing Idorsia from its struggle to prove its stroke drug, Pivlaz (clazosentan), is effective enough to warrant approval in key Western markets.
Questionable efficacy, high priced and risky side effects are some words to describe Leqembi (lecanemab), the latest amyloid beta-targeting antibody approved by the U.S. FDA, Korean experts said, but none of that diminishes the profound significance of the drug for Alzheimer’s disease.
Neuren Pharmaceuticals Ltd. and Acadia Pharmaceuticals Inc. have expanded their development and commercialization partnership for Daybue (trofinetide) beyond the U.S. to take the Rett syndrome treatment to the world in a deal valued at $527 million plus royalties.
Sinotau Pharmaceutical Group raised ¥1.1 billion (US$152 million) in a financing round to develop its radiopharmaceutical drugs for diagnostic and therapeutic interventions.
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.
Incannex Healthcare Ltd. had quietly been developing its commercialization plans for psychedelic clinics well before Australia’s Therapeutic Goods Administration announced it would allow psilocybin and MDMA (3,4-methylenedioxy-methamphetamine) to be prescribed by authorized psychiatrists for treatment-resistant depression and post-traumatic stress disorder.
Regenerative medicine product Stemchymal, an allogeneic adipose-derived mesenchymal stem cell treatment, missed the primary efficacy endpoints in two phase II spinocerebellar ataxia trials conducted in Japan and Korea, but a subpopulation analysis showed efficacy signals in patients with more severe conditions, Reprocell Inc. reported.
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