With a Dec. 20 PDUFA date bearing down on relugolix from Myovant Sciences GmbH, of Basel, Switzerland, freshly released and slightly downbeat secondary endpoint phase III data created a rift with management and analysts on one side and investors on the other.
Ironwood Pharmaceuticals Inc. CEO Mark Mallon said the company will seek to grow Linzess (linaclotide) and “continue to scan the environment” for more prospects in gastrointestinal conditions after the phase III fizzle in one of two identical experiments with IW-3718 in refractory gastroesophageal reflux disease.
A team of scientists at Duke Health has identified biomarkers that accurately detect viral infections before a person becomes symptomatic. The findings were published in The Lancet Infectious Diseases.
The always-busy American Society of Hematology meeting in December promises to include some especially intriguing datasets from the bispecific antibody space, as multiple players are likely to unveil findings related to their CD20xCD3 prospects.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Apeiron, Beyondspring, BMS, Genfit, Hansa, Marinus, Menarini, Novavax, Radius Rhizen, Uniqure.
An independent analysis of studies of Nucleix Ltd.’s Bladder Epicheck demonstrate high diagnostic accuracy and performance in monitoring for disease recurrence in patients with non-muscle invasive bladder cancer (NMIBC).
LONDON – The U.K. will become the first country to stage a human challenge trial in which volunteers are deliberately infected with SARS-CoV-2, as a fast route to assessing the effectiveness of COVID-19 vaccines, and to build understanding of what an effective immune response looks like. The contract research organization Open Orphan plc said it is in advanced negotiations with the U.K. government and other partners for the studies, which are expected to be formally announced next week.
DUBLIN – Afimmune Ltd. is starting a phase IIb trial of a bioactive lipid, epeleuton, in patients with high triglycerides and type 2 diabetes, in an effort to confirm prospective observations already seen in a phase IIa study.
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