Having rung the bell in phase II last summer, Ovid Therapeutics Inc. and Takeda Pharmaceutical Co. Ltd. signed a pact giving the latter global rights to develop and commercialize soticlestat, a first-in-class inhibitor of cholesterol 24-hydroxylase for the treatment of developmental and epileptic encephalopathies including Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS).
Luye Pharma Group Ltd. won marketing approval in China for its risperidone microspheres for injection to treat schizophrenia, which the company said is the first formulation developed by a Chinese company in the space to get a green light. Under the trade name Ruixintuo, the long-acting drug is administered once every two weeks by intramuscular injection.
Israeli cell therapy specialist Neurogenesis Ltd., said new phase II data has shown that treatment with its autologous cell therapy candidate NG-01 in progressive multiple sclerosis (MS) patients led to an 80% to 90% reduction in disease progression at 12 months compared to a pretreatment period and a 90% reduction in relapses compared to placebo-treated patients.
HONG KONG – Gemvax & Kael Co. Ltd. reported the full results from a phase II trial in Korea for GV-1001 (tertomotide), its telomerase modulator, in Alzheimer’s disease, showing a statistically significant improvement in neuropsychiatric inventory and an improvement trend in Alzheimer’s Disease Cooperative Study-Activities of Daily living, the study’s two secondary endpoints.
PERTH, Australia – Clinuvel Pharmaceuticals Ltd. announced two new pharmaceutical indications for its lead product, Scenesse (afamelanotide). “The company has until now focused on one drug and has slowly gathered evidence and is now in a position to add other products to its pipeline,” Clinuvel CEO Philippe Wolgen told BioWorld.
HONG KONG – Aprinoia Therapeutics Inc. is poised to start phase III clinical trials for its positron emission tomography (PET) imaging tracer 18F-APN-1607 in China, after receiving the green light from the National Medical Products Administration.
PERTH, Australia – Sydney-based Actinogen Medical Ltd. will advance its lead compound, Xanamem, into two proof-of-concept phase II studies in Alzheimer’s disease and fragile X syndrome.
Chinese biotech startup Affamed Therapeutics Ltd., funded by CBC Group, has merged with biopharmaceutical company Everinsight Therapeutics Inc., five days after it licensed in a dopamine agonist, KDT-3594, for Parkinson's disease from Japan’s Kissei Pharmaceutical Co. Ltd.
HONG KONG – Shanghai-based Bioshin Ltd., the Asia-Pacific arm of New Haven, Conn.-based Biohaven Pharmaceutical Holding Co. Ltd., has added $60 million to its war chest via a series A investment.
HONG KONG – Tokyo-based Chugai Pharmaceutical Co. Ltd. has launched a subcutaneous injection of Enspryng (satralizumab) in Japan to prevent relapses of neuromyelitis optica spectrum disorder (NMOSD), including neuromyelitis optica (NMO).