Merck & Co. Inc. dropped a bombshell Jan. 25, announcing that it was terminating its two COVID-19 vaccine programs, V-590 and V-591, because neither demonstrated convincing levels of efficacy in phase I trials. As a relatively late entrant to the COVID-19 vaccine race, Merck, of Kenilworth, N.J., was never a leading contender in the effort to bring safe and efficacious vaccines to market. Even so, the failure of these programs is a significant setback, given the company’s scale and experience as a global vaccine manufacturer.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alector, Antios, Astrazeneca, Durect, Dynavax, Exelixis, Genentech, Macrogenics, Medigen, Synairgen, Zydus.
One in five breast cancer conserving surgeries leaves behind some of the tumor. That means patients must schedule a second surgery and then endure additional pain, infection risk, recovery time and cost. Cairnsurgical Inc.'s Breast Cancer Locator system may change that by providing 3D tools that enable surgeons to precisely tailor resection to the shape, size and location of each tumor.
The storm of controversy over the use of paclitaxel in devices for the peripheral vasculature had a dramatic effect on utilization, but a new study coming out of Sweden seems to have helped further ease concerns about purported mortality associated with this antiproliferative. While this unplanned interim analysis lends yet more support to the view that the mortality signal in the so-called Katsanos paper did not reflect a true biological finding, the net effect of the controversy has prompted a call for a registry that might eliminate some statistical noise that had a significant and harmful impact on patients.
Clinical and regulatory data reported in 2020 are up 24% and 47%, respectively, over the prior year, proving to be the busiest 12 months on record for the biopharma industry, in spite of, or perhaps because of, a deadly global pandemic.
At the recent 39th J.P. Morgan Healthcare Conference, Biomarin Pharmaceutical Inc. popped the lid off top-line results from its ongoing phase III GENEr8-1 study with valoctocogene roxaparvovec – also known as valrox, now commonly called Roctavian. Data, though encouraging, may not have quelled controversy around the prospect.
PERTH, Australia – Sydney-based Immutep Ltd. announced that partner Glaxosmithkline plc is discontinuing a phase II ulcerative colitis trial of its anti-lymphocyte activation gene-3 (LAG-3) cell-depleting monoclonal antibody, derived from Immutep’s IMP-731 antibody that GSK licensed in 2010.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aslan, Birchbiomed, Immutep, Nanoform, Regeneron, Sanofi, Senhwa, Windtree.
Medtronic plc is looking to increase market share in pain stimulation with its differential target multiplexed (DTM) therapy, a recharge-free device and its next big disrupter, evoked compound action potential (ECAP). The company is currently developing a closed-loop SCS system for chronic pain following failed back surgery based on ECAP and DTM algorithms.
Antibody development for treating COVID-19 continues producing positive results, the latest being from Eli Lilly and Co.’s bamlanivimab (LY-CoV-555), which reduced nursing home residents’ risk of contracting symptomatic COVID-19 by 80%, according to new data from its phase III Blaze-2 study.
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