New phase III data on Celltrion Inc.'s COVID-19 therapy, regdanvimab, showed it reduced the risk of hospitalization or death related to the disease for high-risk patients to 3.1% vs. 11.1% for placebo by day 28 of the study. The treatment also proved beneficial to participants across all risk categories, reducing their risk of hospitalization or death to 2.4% vs. 8% for placebo at the same time point.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adamis, Astrazeneca, Celltrion, Daiichi, Eyegate, G1, Immvira, Novan, Novavax, Oxthera, Precigen, Roche, Scholar Rock, Terns, Tyme, Vertex, Zynerba.
Novavax Inc. reported an overall efficacy rate of 90.4% in a phase III trial of its COVID-19 protein subunit vaccine, NVX-CoV2373, which it conducted in the U.S. and Mexico. The vaccine provided 100% protection against moderate and severe disease and 100% protection against variants of SARS-CoV-2 deemed not to be of concern or interest. Gaithersburg, Md.-based Novavax is on track to file for approval during the third quarter. By the end of that period, it aims to ramp up production to a monthly run rate of 100 million doses and it aims to scale that to a monthly run rate of 150 million doses by the end of the fourth quarter.
Beigene Ltd. unveiled positive interim results from its Alpine phase III trial comparing its small-molecule BTK inhibitor, Brukinsa (zanubrutinib), to Abbvie Inc.’s Imbruvica (ibrutinib), lending validity to one of the company’s most important development programs.
Takeda Pharmaceutical Co. Ltd. said findings from its phase III Solstice study testing oral antiviral TAK-620 (maribavir) in treating solid organ transplant recipients with cytomegalovirus infections resistant or refractory to prior therapy (R/R CMV), showed twice the rate of confirmed CMV viremia clearance compared to other conventional therapies.
Data from a prospective study rolled out by Allakos Inc. last month at the Digestive Disease Week meeting made the case for broader prevalence than previously believed of eosinophilic gastritis and/or eosinophilic duodenitis – and the Redwood City, Calif.-based firm may have just the drug for the conditions in lirentelimab (AK-002).
Sanofi SA has announced new pivotal data that will form the basis of a refiling of rare disease drug sutimlimab for people with cold agglutinin disease (CAD).
It’s back to the drawing broad for Vertex Pharmaceuticals Inc. and its efforts to develop treatments for the rare disease alpha-1-antritrypsin deficiency (AATD), after its VX-864 produced disappointing results in a phase II trial.
New phase III data on Novan Inc.'s molluscum contagiosum candidate showed it cleared all lesions associated with the highly contagious viral skin infection in 32.4% of trial participants who received it vs. 19.7% provided a placebo. Paired with what company President and CEO Paula Brown Stafford called "strong safety," the result gives the company's team confidence as it moves toward an NDA submission for the topical antiviral, SB-206, she said.
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