About two weeks after chikungunya virus (CHIKV) vaccine contender Bavarian Nordic A/S provided phase III data with its prospect, rival Valneva SE rolled out positive phase III safety findings in adolescents with its single-dose candidate VLA-1553. Results from the Saint-Herblain, France-based company’s first trial in an endemic area with people previously infected with CHIKV showed the product was generally safe and well-tolerated in subjects aged 12-17 years, regardless of previous infection by the mosquito-borne disease, carried mainly by Aedes aegypti and Aedes albopictus. Immunogenicity data from the study are expected in November. Read More
As its name suggests, Superluminal Medicines Inc. is aiming for speed. The startup, which closed a $33 million seed round led by RA Capital Management, is combining a biology-focused approach with a generative AI platform it says has the potential to create candidate-ready compounds in a matter of months, with its initial sights set on G protein-coupled receptor targets. Read More
Omnix Medical Ltd. is gearing up for a phase II trial next year of its novel peptide-based antibiotic OMN-6, the lead compound in a pipeline inspired by the antimicrobial strategies of insects. Read More
The U.S. FTC has recalibrated its challenge to Amgen Inc.’s $27.8 billion acquisition of Horizon Therapeutics plc while one of the biggest trade groups has voiced its concerns about the government’s role in the deal. An amicus brief from the Biotechnology Innovation Organization (BIO), along with the Illinois Manufacturers Association, the Chicagoland Chamber of Commerce and the Illinois Biotechnology Innovation Organization, calls the FTC expansion into such deals overreach that chills pro-competitive biopharma mergers. Read More
Seoul, South Korea-headquartered Boryung Co. Ltd. grabbed headlines in 2022 with its strategic redesign to move beyond drug development, announcing that it would invest $10 million in Axiom Space Inc. for a 0.4% stake in the U.S. commercial space station developer. The investment ramped up over the course of a year, with Boryung pouring a total of $60 million into Axiom Space over two financing rounds for a 2.7% stake. Axiom is set to build the world’s first commercial space station. Read More
Cochlear Ltd. and Sensorion SA have published encouraging results on the combination of a molecule with a cochlear implant. Their proof-of-concept phase 2a study involved the combination of an orphan drug recognized in both Europe and the U.S. with cutting edge hearing aid implants to enhance the auditory capabilities of hearing aid users. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Amneal, Clarity, Maplight, Merck, Novo Nordisk, Nura, Thryv, Xylocor, Zhiyu. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Astellas, Axovia, Briacell, BMS, Bridgene, CSL, Immunogen, Genfleet Immunogen, Latern, Novartis, Pfizer, Sandoz. Specialised, Takeda, Treeway, Tris, Verastem, Xoma. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akeso, Ausper, Ausperbio, Everest, Janssen, Pfizer, Sandoz. Read More
