Cardiac Dimensions Inc. launched the Empower trial of its Carillon mitral contour system for the treatment of heart failure patients with early-stage functional mitral regurgitation. The company expects to enroll up to 300 patients at 75 sites in the international, randomized, sham-controlled trial.
Astrazeneca plc, en route to potentially delivering a new protection against COVID-19 for people inadequately protected by or unable to be vaccinated, has cleared a crucial hurdle with its long-acting combination therapy, AZD-7442, which met the goals of a phase III pre-exposure prophylaxis trial. The U.K.-based pharma’s readout arrived just as Regeneron Pharmaceuticals Inc. announced the MHRA’s conditional marketing authorization for its Roche Holding AG-partnered COVID-19 antibody therapy Ronapreve (casirivimab + imdevimab), also known as REGEN-COV.
A month after Astrazeneca plc’s $39 billion takeover of Alexion Pharmaceuticals Inc. was finalized, the merged company has hit its first speed bump after the new unit discontinued a phase III rare disease trial. Alexion, of Boston, said it axed the 382-patient CHAMPION-ALS trial of its long-acting C5 complement inhibitor Ultomiris (ravulizumab) in amyotrophic lateral sclerosis (ALS).
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Astrazeneca, Coherus, Compugen, Intrabio, Janssen, Junshi, Nervgen, Nrx, Scioto, Zealand, Zhaoke.
Jorge Ulloa of Hancock Jaffe Laboratories Inc. presented positive results from a first-in-human trial of implantation with its Venovalve device at the Society for Vascular Surgery annual meeting in San Diego. Two years following surgery, outcomes included more than 60% improvements in reflux and disease manifestations and 93% decrease in pain in patients with chronic venous insufficiency with no safety issues or venous ulcer recurrences.
LONDON – The latest data from the large-scale randomized U.K. COVID-19 infection survey confirm vaccines are less effective against the Delta variant of SARS-CoV-2 that is now dominant across the U.S., Europe and elsewhere in the world.
LONDON – Persica Ltd. is poised to take a new pharmaceutical approach to curing chronic lower back pain, after delivering positive data in a phase Ib study of an injectable antibiotic. The development rests on research showing that, as with stomach ulcers, chronic lower back pain is caused by localized bacterial infection.
Coherus Biosciences Inc. and partner Shanghai Junshi Biosciences Co. Ltd. continued to build their case for the anti-PD-1 antibody toripalimab, popping the lid off positive interim data from the pivotal, combination phase III study called Choice-01 in first-line advanced squamous or non-squamous non-small-cell lung cancer (NSCLC).
LONDON – The latest data from the large-scale randomized U.K. COVID-19 infection survey confirm vaccines are less effective against the Delta variant of SARS-CoV-2 that is now dominant across the U.S., Europe and elsewhere in the world.
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