Clinical updates, including trial initiations, enrollment status and data readouts and publications: Apellis, Bold, Caladrius, CSL, Emergent, Gilead, Grifols, Pfizer, Rigel, Sobi, Sumitomo Dainippon, Takeda, University of Oxford.
San Carlos, Calif.-based Galaxy Medical Inc., which has developed pulsed electric field (PEF) technology for the treatment of cardiac arrhythmias, revealed the first treatments in the ECLIPSE-AF study, which is evaluating the Centauri system. The trial will assess the safety and efficacy of the Centauri as the company looks forward to obtaining a CE mark.
LONDON – Industry is calling on the government to set out a plan for the safe and sustainable restart of non-COVID-19 clinical studies that were put on hold when the pandemic struck.
Dublin-based Jazz Pharmaceuticals plc’s phase III top-line win with Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution in adults with idiopathic hypersomnia (IH) provides the company with a needed foothold there as generics threaten its other sleep disorder drug, Xyrem (sodium oxybate).
Shares in Cytokinetics Inc. closed down 42% Oct. 8 on news that omecamtiv mecarbil, a heart failure drug which it is developing with Amgen Inc. (with funding and strategic support from Les Laboratoires Servier SAS), failed to demonstrate a survival benefit in a large-scale cardiovascular outcomes study.
LONDON – Industry is calling on the government to set out a plan for the safe and sustainable restart of non-COVID-19 clinical studies that were put on hold when the pandemic struck.
PERTH, Australia – Astrazeneca plc is leasing 175 Sozo devices from Impedimed Ltd. and plans to put them in 20 countries to run phase II trials for a combination drug that looks at fluid imbalance in the human body in patients with heart failure (HF) and chronic kidney disease.
LONDON – Clinical care guidelines recommending the use of the HIV/AIDS combination lopinavir-ritonavir for the treatment of patients hospitalized with COVID-19 must now be updated, say the authors of a paper reporting the full results of a randomized U.K. study.