Pairing the in-licensed muscarinic acetylcholine receptor agonist xanomeline with the well-known muscarinic antagonist trospium chloride in the single drug called Karxt gave Karuna Therapeutics Inc. the required phase II efficacy against acute psychosis in schizophrenia, while keeping a quite satisfactory safety and side-effect profile. Read More
In a bid to expand its presence in CNS to a wider range of neurodegenerative diseases following a substantial restructuring last month, Alkermes plc has moved to acquire privately held neuronal epigenetics specialist Rodin Therapeutics Inc. for $100 million up front and up to $850 million in clinical, regulatory and commercial milestones. Read More
Dicerna Pharmaceuticals Inc. kept adding major partners to its CV Monday as it and Novo Nordisk A/S struck a deal to discover and develop therapies to treat liver-related cardiometabolic diseases, including chronic liver disease, nonalcoholic steatohepatitis (NASH), type 2 diabetes, obesity and rare diseases. Read More
LONDON – “Innovation only matters if patients benefit.” So said Guido Rasi, executive director of the EMA, as the agency embarks on the next phase of updating its regulatory science, both to tap into a torrent of new technologies and to ensure drug development generates evidence to demonstrate cost effectiveness and speed up access. Read More
There are a pair of approved CAR T drugs, Yescarta (axicabtagene ciloleucel) from Gilead Sciences Inc. and Kymriah (tisagenlecleucel) from Novartis AG, that have been available since 2017 for a few hematological cancers, including some lymphomas and leukemias. Read More
SHANGHAI – Although China still has a way to go to approve any CAR T therapy, clinical development is robust with various targets being studied, and the regulatory environment is improving, cell therapy experts said at the Chinatrials 12 Summit. Read More
HONG KONG – South Korean pharmaceutical giant Yuhan Corp. has invested ₩3 billion (US$2.6 million) in SL Bigen Co. Ltd., a Korean biotech based in Seongnam, Gyeonggi-do, that is focused on chimeric antigen receptor-directed natural killer (CAR-NK) therapy. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations. Read More
