Geneva-based Obseva SA’s top-line data from the pivotal phase III studies called Primrose 1 and 2 with GnRH antagonist Yselty (linzagolix) pleased the company, but Wall Street not so much.
DUBLIN – Idorsia Ltd. plans to file an NDA before the year-end for its insomnia drug, daridorexant, following a read-out of top-line data from a second phase III study, which the company said closely tracked an earlier phase III study, although it failed to meet one of two primary endpoints with statistical significance.
The failure of an experimental refractory chronic cough drug to yield statistically significant reductions in placebo-adjusted cough frequency sent shares of its developer, Bellus Health Inc. (NASDAQ:BLU), down 71.7% to $3.40 on July 7.
PARIS – Quantum Surgical SAS said it has achieved a world first at the Montpellier University Hospitals by successfully using its medical robot to perform surgery on three patients with liver cancer.
Just shy of four years ago, MEI Pharma Inc. and Helsinn Group hashed out a $464 million deal to develop and commercialize pracinostat. Now an interim futility analysis has persuaded them to halt their phase III study in acute myeloid leukemia (AML) while, pending further evaluation, patients enrolled in other pracinostat studies continue their treatment.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 4D, Abivax, Apellis, Biocardia, Menarini, Moleculin, Pfizer, Vaccibody.
Researchers working as part of the Quantitative Imaging Biomarkers Alliance (QIBA) have recently validated an open-source algorithm that can be used to measure blood flow using existing 3D ultrasound technology from major manufacturers. They published their results in the June 30, 2020, issue of Radiology.
Strongly positive histological data from Akero Therapeutics Inc. is being seen as setting a potentially new high bar in treating nonalcoholic steatohepatitis (NASH), but 89bio Inc.’s NASH treatment, on a similar development timeline, is sharing in the success.
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