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.
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.
New data from a global phase II trial of Kiniksa Pharmaceuticals Ltd.'s monoclonal antibody, mavrilimumab, in the rare chronic inflammatory disease giant cell arteritis showed a 62% lower risk of flare in patients receiving the candidate vs. those given a placebo.
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