DUBLIN – The Lancet Infectious Diseases has published the first clinical data on BBIBP-CorV, an inactivated whole virus vaccine directed against SARS-CoV-2. The early stage phase I/II study tested the Chinese-developed vaccine in 540 healthy volunteers, including 96 older participants. All vaccine recipients seroconverted and the adverse event profile was mild.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Anavex, Apellis, Astex, Castle Creek, Eiger, GNT, Ionis, J&J, Janssen, Kalvista, Lysogene, Oryzon, Otsuka, Regenrx, Regulus, Sage, Vertex.
Axon Therapies Inc. has developed an ablation system and method that treats the underlying problems in patients with heart failure with preserved ejection fraction (HFpEF), with an eye toward improving their quality of life.
A study blending intravascular ultrasound and near-infrared spectroscopy, presented at TCT Connect 2020, makes the argument that lipid-rich, nonobstructive lesions are responsible for most major adverse cardiac events after percutaneous treatment.
Medtronic plc has kicked off two clinical trials of its Evolut transcatheter aortic valve replacement (TAVR) system. One study will pit the self-expanding Evolut Pro and Pro+TAVR systems against Edwards Lifesciences Corp.’s balloon-expandable Sapien 3 and Sapien 3 Ultra transcatheter heart valves in small annulus patients.
Despite an NIH move to pause enrollment in a trial testing Eli Lilly and Co.'s COVID-19 antibody candidate, LY-CoV555, after a participant's unexplained illness, at least three other studies of the candidate remain underway, the company said Oct. 14.
Cyclerion Therapeutics Inc.’s phase II blowup with sickle cell disease (SCD) candidate olinciguat ended its development, and attention turned to the Cambridge, Mass.-based firm’s earlier-stage effort with IW-6463, a drug in the same class for central nervous system (CNS) disorders.
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.
Gossamer Bio Inc.’s finding of a subset of especially good responders in the phase IIb study called Leda may have taken some of the edge off two failures with GB-001, an oral DP2 antagonist undergoing tests in asthma and chronic rhinosinusitis. But the Street still wasn’t happy, and shares (NASDAQ:GOSS) of the San Diego-based firm closed Oct. 13 at $10.09, down $3.50, or 26%.
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