In a deal that could be worth up to $565 million, Simcere Pharmaceutical Group Ltd. licensed in glutaminyl cyclase inhibitor varoglutamstat (PQ-912) and monoclonal N3pE-antibody PBD-C06, which target the neurotoxic amyloid species N3pE (pGlu-Abeta), from Vivoryon Therapeutics AG to develop and commercialize for Alzheimer’s disease in greater China.
New FDA breakthrough therapy designations awarded for two investigational Alzheimer's disease (AD) candidates, Eli Lilly and Co.'s donanemab and the Bioarctic AB-Eisai Co. Ltd.-developed asset lecanemab (BAN-2401) underline ongoing willingness at the U.S. regulator to invest deeper attention in the potential of amyloid plaque reduction to slow progress of the disease, a critical and costly challenge estimated to affect more than 6 million Americans.
PERTH, Australia – Implicit Bioscience Ltd.’s lead candidate, IC-14, is the first anti-CD14 monoclonal antibody (MAb) to progress to the clinic as it enters a phase II trial in the U.S. in COVID-19 patients.
HONG KONG – SK Biopharmaceuticals Co. Ltd. partner Arvelle Therapeutics GmbH, now part of Angelini Pharma, has received European Commission (EC) approval for Ontozry (cenobamate), a treatment for drug-resistant focal-onset seizures. The approval was granted for focal-onset seizures with or without secondary generalization in adults who have not been adequately controlled despite a history of treatment with at least two anti-epileptic medicines.
Bridgene Biosciences Inc., a company using an in-house chemoproteomic platform to find and develop small molecules for hard-to-drug targets, has signed its first major pharma partnership with Takeda Pharmaceutical Co. Ltd. for an undisclosed up-front payment.
HONG KONG – Otsuka Pharmaceutical Co. Ltd. is celebrating its 100th anniversary by inking a collaboration and licensing agreement with Perception Neuroscience LLC to develop and commercialize the latter’s PCN-101 (r-ketamine) in Japan.
Small-molecule mRNA translation expert Anima Biotech Inc. has landed a significant new preclinical research deal with Takeda Pharmaceutical Co. Ltd., covering as many as six programs for genetically defined neurological diseases. The deal starts with $120 million in up-front and preclinical research milestone payments for Anima, but altogether the two-part collaboration could hold as much as $2.3 billion.
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.
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