SK Biopharmaceuticals Co. Ltd.'s three-pronged plan for tackling epilepsy is going strong, with lead drug cenobamate for drug-resistant focal-onset seizures nearing the finish line, and earlier-stage programs for a mRNA-based approach and a digital therapeutic in the works.
Shanghai Junshi Biosciences Co. Ltd. and Coherus Biosciences Inc. have disclosed positive data from a phase III trial of the anti-PD-1 antibody toripalimab in combination with chemotherapy in China.
Hutchmed Ltd. has received a $15 million milestone payment from Astrazeneca plc for initiating a phase III trial testing the Hutchmed c-Met inhibitor Orpathys (savolitinib) in combination with Astrazeneca’s Tagrisso (osimertinib) in EGFR-mutated non-small-cell lung cancer.
PERTH, Australia – Prota Therapeutics Ltd.’s lead candidate PRT-120 induced clinical remission of peanut allergy in 51% of children in a phase IIb clinical trial. There are currently no curative therapies to treat food allergies, Prota Therapeutics CEO Mimi Tang told BioWorld. Peanut allergy in children can be particularly problematic because the only treatment is avoidance.
Livzon Pharmaceutical Group Inc.’s key interim data from the phase III trials of its recombinant SARS-CoV-2 fusion protein vaccine, V-01, has shown efficacy against the omicron variant. The phase III trial aims to evaluate the efficacy, safety and immunogenicity of V-01 as a booster in adults older than 18 after they have received two doses of inactivated vaccines.
Although diversity was front and center, it wasn’t the only reason the U.S. FDA’s Oncologic Drugs Advisory Committee voted 14-1 on Feb. 10 that additional clinical trials demonstrating applicability to the U.S. non-small-cell lung cancer population are needed before sintilimab, a PD-1 inhibitor partnered in the U.S. by Innovent Biologics Co. Ltd. and Eli Lilly and Co., is ready for approval.
More than 100 million people worldwide are thought to have post-acute COVID-19 syndrome, roughly 40% of everyone on the planet who’s had COVID. Now, thousands of them are beginning to cycle through clinical and preclinical studies designed to get a better look at this little understood aspect of the pandemic.
As COVID-19 infections in Australia continue to mount, a dozen or so Australian compounds are winding their way through the pipeline that could offer additional protection to the vaccines and antivirals that are already provisionally approved by Australia’s TGA.
With phase Ib data published in The Lancet Microbe showing Suzhou Abogen Biosciences Co. Ltd.’s ARCoV had acceptable safety and induced a strong immune response, partner Walvax Biotechnology Co. Ltd. is continuing to enroll participants in a large phase III test of the vaccine.
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