Much of the noise surrounding transcatheter aortic valve replacement (TAVR) vs. its surgical counterpart has to do with residual paravalvular leak. However, a new paper in the Journal of the American College of Cardiology (JACC) seems to have overwritten that consideration. The underlying registry study indicates that procedural success and outcomes at one year are superior in TAVR to in SAVR – yet another piece of evidence that seemingly tips the scales even more toward TAVR devices.
Sarepta Therapeutics Inc.’s miss on a key phase II ambulatory endpoint in its Duchenne muscular dystrophy (DMD) trial may have been caused by a dramatic disparity in functional ability at baseline among older vs. younger patients afflicted with the progressively worsening disorder. In any case, Wall Street had knives out, carving 51% of the value away from shares (NASDAQ:SRPT) of the Cambridge, Mass.-based firm, which closed at $82.29, a loss of $86.66, or 51%.
Alnylam Pharmaceuticals Inc. said the 164-patient Helios-A phase III study with next-generation RNAi drug vutrisiran hit its primary endpoint as well as both secondary goals in the treatment of hereditary transthyretin-mediated amyloidosis with polyneuropathy. The primary endpoint was change from baseline in the modified Neuropathy Impairment Score at nine months as compared to historical placebo data from the Apollo phase III study of Alnylam’s Onpattro, cleared by the FDA for ATTR polyneuropathy in August 2018.
LONDON – The U.K. is to make treatment with interleukin-6 (IL-6) inhibitors standard of care for critically ill COVID-19 patients after a randomized trial found the arthritis drugs significantly improve survival.
CAJICA, Colombia – Brazil's Butantan Institute and the government of the state of Sao Paulo released efficacy results on Jan. 7 for Coronavac, developed by China’s Sinovac Biotech Ltd., that suggest the COVID-19 vaccine is more than 78% effective.
DUBLIN – Curevac AG has entered a global alliance with Bayer AG to accelerate its efforts to bring a third, desperately needed mRNA-based COVID-19 vaccine to market. The vaccine in question, CVnCoV, began a pivotal phase IIb/III trial on Dec. 14.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbvie, Aldeyra, Alnylam, AM-Pharma, Basilea, Pfizer, Pharmaessentia.
A new imaging technology that uses transmission ultrasound to provide a 3D image of breast tissue outperformed traditional digital mammography in a recent retrospective analysis. The study findings could set the stage for the U.S. FDA to clear the technology for breast cancer screening in young, high-risk women.
Nextgen Biomed Ltd. has begun a clinical trial of a breath test to monitor antibody levels in individuals vaccinated against COVID-19. Be'er Ya'akov, Israel-based Shamir Medical Center authorized the trial for test developer Scent Medical Technologies Ltd. (Scentech Medical), which is in the midst of merging with Nextgen. The merged company will be called Scentech Medical.
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