DUBLIN – Genentech has succeeded where Sanofi SA and its partner, Regeneron Pharmaceuticals Inc., have failed, in obtaining some sort of a positive signal from a clinical trial of an interleukin-6 (IL-6) inhibitor in COVID-19.
LONDON – CEOs of five leading biopharma companies have hit back against any suggestion COVID-19 vaccines and therapies could be approved in advance of phase III data, saying it is imperative the highest standards of quality, safety and efficacy are upheld everywhere. The most important thing is to reinforce to the public the commitment to safety as the number one priority, said Kenneth Frazier, CEO of Merck & Co. Inc.
DUBLIN – Sanofi SA and Regeneron Pharmaceuticals Inc. are terminating all further development in COVID-19 of their interleukin-6 receptor inhibitor, Kevzara, following the antibody’s failure to meet the primary endpoint, as well as a key survival endpoint.
Four years after the EMA first approved Novartis AG's Ilaris (canakinumab) for the treatment of adult-onset Still’s disease (AOSD), the FDA has followed suit, giving it a green light in the indication following a priority review. The rare rheumatic condition usually affects younger adults and can occur as infrequently as once, but also intermittently or chronically.
LONDON – In the first major breakthrough in therapeutics for COVID-19 infection, dexamethasone has been shown to have a statistically significant impact on mortality in the most seriously ill patients.
LONDON – In a potent demonstration of how COVID-19 is transforming the U.K. clinical trial landscape, 47,000 patients have been recruited to studies investigating potential treatments for the infection in a little over two months.
LONDON – The U.K. has started a fast track national trial of experimental drugs in COVID-19 patients, with Bergenbio ASA’s phase II cancer immunotherapy, bemcentinib, the first of six products that are due to join the study.
DUBLIN – The Genentech arm of Basel, Switzerland-based Roche Holding AG plans to move its interleukin-6 (IL-6) inhibitor, Actemra (tocilizumab), into a global phase III trial in patients with severe pneumonia associated with COVID-19 infection.