South Korea may soon gain its first domestically developed anthrax vaccine by GC Biopharma Corp., with the Korean biotech having filed Nov. 1 with the MFDS for approval of its novel recombinant protein anthrax vaccine called GC-1109.
A year-and-a-half after Eli Lilly and Co.’s Mounjaro (tirzepatide) gained U.S. FDA approval for adults with type 2 diabetes, the GLP-1 and GIP dual agonist was cleared for chronic weight management in adults who are obese or overweight and who also have one related condition.
Johnson & Johnson expects to submit the long-awaited Ottava robotic surgical system to the U.S. FDA for an investigational device exemption (IDE) in the second half of 2024, nearly three years later than the company anticipated when its Ethicon Inc. unit acquired Ottava along with Auris Health Inc. in 2019.
As reported ipreviously in coverage by BioWorld, the U.S. FDA’s latest guidance on cybersecurity elevates the agency’s demands for medical device cybersecurity, but the agency advised industry in a recent webinar that hospital IT systems are fraught with cybersecurity hazards of their own, and thus device makers should view these IT systems as potentially hostile environments where cybersecurity is concerned.
Grace Science LLC has received FDA clearance of its IND application for GS-100, an AAV9 gene replacement therapy for the treatment of NGLY1 deficiency.
Abbisko Therapeutics Co. Ltd. has received FDA clearance of its IND application for ABSK-012, a highly selective small-molecule inhibitor of fibroblast growth factor receptor 4 (FGFR4), for advanced solid tumors.
Briacell Therapeutics Corp. has received IND clearance from the FDA to begin clinical studies with Bria-OTS, the first generation of the company’s personalized off-the-shelf cellular immunotherapy for breast cancer.
Angiex Inc. has received FDA clearance of its IND application for AGX-101, a novel TM4SF1-directed antibody-drug conjugate (ADC) being developed for the treatment of solid cancers.