A phase III failure of Swedish Orphan Biovitrum AB's oral thrombopoietin receptor agonist avatrombopag to effectively outperform a placebo in treating chemotherapy-induced thrombocytopenia, or low platelet counts, sent company shares down 17.9% on Oct. 9.
As clinical trials, halted due to the COVID-19 pandemic, begin to resume and biopharma companies find workarounds to keep the research going, activity in phase I, II and III studies picked up by more than 40% in September.
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.
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