Activity in some clinical parameters is leading Atyr Pharma Inc. to plan a sit-down with regulators, even though the tRNA synthetase-derived drug efzofitimod missed its primary endpoint of steroid tapering in the phase III Efzo-Fit study against the interstitial lung disease pulmonary sarcoidosis (PS). CEO Sanjay Shukla said his firm maintains “a high degree of conviction” regarding the candidate. “But I want to make sure we have the best briefing book possible” before consulting with the U.S. FDA, which will happen as soon as possible.
Several South Korean biotech and biopharmaceutical companies completed IND submissions or won nods to start clinical trials in either the U.S. or South Korea, including SK Bioscience Co. Ltd., Genosco Inc., Pimedbio Inc., Sillajen Inc. and Ami Pharm Co. Ltd.
The U.S. FDA cleared Respiree Pte. Ltd.’s 510(k) for its RS-001 cardio-respiratory wearable that measures respiration and offers passive cardio-respiratory monitoring.
Several South Korean biotech and biopharmaceutical companies completed IND submissions or won nods to start clinical trials in either the U.S. or South Korea, including SK Bioscience Co. Ltd., Genosco Inc., Pimedbio Inc., Sillajen Inc. and Ami Pharm Co. Ltd.
Anima Biotech Inc. has divulged collagen 1 (COL1) translation inhibitors reported to be useful for the treatment of cirrhosis, fibrosis, nonalcoholic or metabolic dysfunction-associated steatohepatitis (NASH/MASH), alcoholic fatty liver and autoimmune diseases.
South Korea’s Ministry of Food and Drug Safety approved Moderna Inc.’s Spikevax LP.8.1 vaccine as an updated shot for COVID-19 targeting the LP.8.1 variant, according to Moderna Korea’s announcement Sept. 1. The regulatory clearance comes days after the U.S. FDA accepted, on Aug. 27, Moderna’s supplemental BLAs for two of its COVID-19 vaccines, Spikevax and Mnexspike.
Following positive data from competitors earlier this year, United Therapeutics Corp. rolled out impressive and unexpected phase III results of nebulized Tyvaso (treprostinil) for idiopathic pulmonary fibrosis (IPF), setting the stage for an sNDA filing with the U.S. FDA next year. If approved for the indication, United, of Silver Spring, Md., and Research Triangle Park, N.C., could tap into what analysts say is a $4 billion-plus market.
Recently launched Irish startup Phyxiom Ltd. hopes that its digital health platform will transform the clinical outcomes for patients with asthma and chronic obstructive pulmonary disease. By providing clinicians with real-time insights into lung function and medication adherence, the platform improves diagnosis accuracy and treatment outcomes.
French vaccines specialist Osivax SAS has been awarded $19.5 million by the U.S. Biomedical Advanced Research and Development Authority (BARDA) to fund work on its universal influenza A vaccine.
Chinese researchers have developed a new a circulating exosomal proteomic biomarker signature that may aid in the diagnosis of interstitial lung disease (ILD) in combination with computed tomography. Exosomes may contribute to lung disorders by carrying cargoes that promote inflammatory responses in immune and lung epithelial cells. The assay was performed in a case-control biomarker study; exosomes from 168 serum samples were extracted and submitted to proteomic analysis.
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