New data show Johnson & Johnson’s Erleada (apalutamide) and Xtandi (enzalutamide) from Pfizer Inc. and Astellas Pharma Inc. both prolonged overall survival in men with non-metastatic castration-resistant prostate cancer (nmCRPC).
DUBLIN – Abivax SA has rejected an acquisition offer in order to pursue a phase IIb/III trial of its lead anti-inflammatory drug ABX-464 in 1,034 COVID-19 patients.
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.
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. The World Health Organization (WHO) has just released guidelines for assessing the ethical acceptability, saying such trials would allow for more rapid and standardized testing, accelerating development and enabling candidates to be prioritized.
Quanterix Corp., of Billerica, Mass., reported that researchers have developed a COVID-19 antibody test with 1,000 times the sensitivity of current tests using its Simoa bead-based immunoassay platform.
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.
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