Zydus Cadila Ltd. has applied for emergency use authorization in India for its DNA plasmid COVID-19 vaccine, potentially the first shot of its kind to be approved in humans. The filing for the vaccine called ZyCoV-D will be based on a phase III study showing efficacy of 66.6% for symptomatic disease and 100% efficacy for moderate disease.
Sequana Medical NV reported positive results from the second interim analysis of its POSEIDON pivotal study evaluating the Alfapump for the treatment of recurrent or refractory ascites due to liver cirrhosis. These latest results, from 26 patients in the roll-in cohort, affirm earlier interim data showing high scores on all primary endpoints and continued improvement in quality of life.
As confirmed cases and deaths from COVID-19 continue their downward slide, biopharma research efforts remain front and center, providing a new therapeutic for emergency use in the U.S. and high-efficacy phase III data for what could become the country’s fourth vaccine and its first protein subunit option.
New top-line data from Kintara Therapeutics Inc.’s phase II study of its lead candidate, VAL-083, in recurrent glioblastoma multiforme were incrementally better than data released in April, and that’s just fine with CEO Saiid Zarrabian. “Normally, in my experience, top-line data usually regresses a little,” Zarrabian told BioWorld. “The fact that it improved could be a reflection of the small size of the study, but it adds a little more interest to top-line data.”
The COVID-19 vaccine from Curevac AG looks far less protective than mRNA-based rivals, according to phase IIb/III data, but the company suggested it could still be approved in younger age groups or supplied to poorer countries at lower cost.
Neuropace Inc. nabbed $9 million in the form of a five-year NIH grant as part of the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative. The grant will support the study of the Mountain View, Calif.-based company’s Responsive Neurostimulation (RNS) system in patients with Lennox-Gastuat syndrome (LGS), a debilitating form of epilepsy.
Shares in Altimmune Inc. and Angion Biomedica Corp. were sharply down after the companies announced trial disappointments from a nasal COVID-19 vaccine and two investigational therapies. Altimmune was worst hit, with shares (NASDAQ:ALT) dropping 38% to $9.80 June 30 after announcing its nasal COVID-19 vaccine did not produce enough immune response and axing an immunotherapy trial after encountering problems finding enough subjects.
Hightide Therapeutics Inc. presented top-line results of its lead program, HTD-1801, from a multicenter phase II trial in primary sclerosing cholangitis (PSC), which showed the drug candidate reduced alkaline phosphatase levels compared to placebo.
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