PERTH, Australia – Stem cell therapy company Mesoblast Ltd. provided new subgroup analyses from its phase III advanced chronic heart failure trial showing a greater treatment benefit from rexlemestrocel-L in high-risk patients with chronic heart failure and low ejection fraction (HFrEF) with diabetes or ischemia.
Little more than a year since FDA approval of its COVID-19 vaccine, Pfizer Inc. has published final phase II/III data on its oral antiviral candidate, Paxlovid (nirmatrelvir + ritonavir), confirming that, for non-hospitalized, high-risk adults with COVID-19, taking the drug within three days of symptom onset reduced all-cause risk of hospitalization or death by 89% vs. placebo.
The error in phase III data reported in late October that sank Galera Therapeutics Inc.’s stock (NASDAQ:GRTX) has been corrected, prompting share values to nearly double on Dec. 14. The error, according to J. Mel Sorensen, Galera’s president and CEO, had resulted in a false “p” value, leading the company to report the study had failed to achieve statistical significance on its primary endpoint. He called the programming error that caused the confusion “quite subtle.”
Two trials presented at the annual meeting of the American Society of Hematology (ASH) showed that treatment with the antithrombin inhibitor fitusiran reduced the bleeding rate in patients with severe hemophilia by roughly 90%, regardless of whether they had type A or B, and whether they had developed antibodies to recombinant clotting factors.
Orca Bio Inc. reported at the American Society of Hematology that cancer patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT) who received its Orca-T cell therapy product achieved higher rates of survival without experiencing either relapse or chronic graft-vs.-host (GvHD) disease than those who received a conventional graft.
LONDON – There was a substantial fall in neutralization titers against the Omicron variant of SARS-CoV-2 in the stored sera of people who had received two doses of either Astrazeneca plc’s or Pfizer Inc./Biontech SE’s COVID-19 vaccines, with some samples failing to neutralize the virus at all, according to the latest data from the U.K. Com-Cov study.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Active Biotech, Aeromics, Angion, Beigene, Carrick, Clene, Eucure, Gilead, Immunic, Moderna, Obseva, Roche, Simcere, UCB, Vifor.
Core presentations at the 63rd meeting of the annual American Society of Hematology (ASH) began Saturday morning with the presentation of three studies focused on non-Hodgkin lymphomas and one on multiple myeloma (MM). Each approach used the immune system as a cancer fighter but employed different mechanisms of action. Two of them successfully used CAR T therapies as treatment.
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