Despite evidence of efficacy in binge-eating disorder (BED), Sunovion Pharmaceuticals Inc.'s dasotraline's second lease on life is done, for now. Following an initial plan to discontinue the asset in a 2010 portfolio reshuffle, the drug is now being shelved due to the need for additional clinical studies on its benefit-risk profile, parent Sumitomo Dainippon Pharma Co. Ltd. said.
BEIJING – Shandong, China-based Luoxin Pharmaceuticals Group Stock Co. Ltd. said its PIK3α inhibitor, LX-086, has been approved by China’s National Medical Products Administration (NMPA) to enter clinical trials for advanced solid tumors, two weeks after Novartis AG’s alpelisib, which aims at the same target, was also granted IND clearance in China.
HONG KONG – Singapore-based Proteona Pte. Ltd. has started a partnership to characterize the clinical response to a new COVID-19 vaccine, with clinical trials soon to start at Flinders Medical Centre testing the candidate developed in collaboration with Adelaide, Australia-based Vaxine Pty Ltd.
Two companies developing nonalcoholic steatohepatitis (NASH) therapies found themselves at opposite ends of the spectrum Tuesday, with Cymabay Therapeutics Inc. potentially getting a second chance while the door slammed on Genfit SA’s hopes.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Galderma, Galera, Gamida, Genfit, Glenmark, Marker, Minoryx, Neurana, Ocular Therapeutix, Rocket, Sanofi.
The phase III pivotal trial of mavacamten, an oral, allosteric cardiac myosin modulator for treating symptomatic, obstructive hypertrophic cardiomyopathy, from Myokardia Inc., of Brisbane, Calif., hit its primary and all of its secondary endpoints.
LONDON – Support is growing for human challenge trials in COVID-19 to be approved in order to speed up development of effective vaccines against the pandemic infection.
DUBLIN – Tolerogenixx GmbH is on track to move its cell-based immune tolerance induction therapy for kidney transplant recipients into a 200-patient phase IIb trial, following the publication of promising data from a phase Ib trial, in 10 patients, in which all participants had a successful transplant at one-year follow-up.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 4D Pharma, Infinity, Kiniksa, Lilly, Merck, Myokardia, Oyster Point, Protalix, Strongbridge, Tolerogenixx.
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