Many industry watchers are looking to 2023’s Humira biosimilar launch in the U.S. as a portent of the future of biosimilars. While it should help raise awareness of biosimilars in general and produce savings in the immunology sector, its distinctness could make it an outlier in the world of current and future biosimilar competition. Read More
It was a busy day at Moderna Inc. as Merck & Co. Inc. exercised its option to jointly develop and commercialize a personalized cancer vaccine with Moderna in a deal the two companies inked in 2016. Moderna also notched another emergency use authorization (EUA) for its COVID-19 vaccine, this one targeting the omicron variant, for use by those under age 18. Read More
Vividion Therapeutics Inc. has signed a potential $930 million deal with Tavros Therapeutics Inc., focused on finding four cancer targets using the latter’s technology that aims to exploit weaknesses in tumor cells and cause them to self-destruct. Read More
Ascidian Therapeutics Inc. secured $50 million in series A funding from its founder Apple Tree Partners to take a therapy based on its RNA exon editing technology into a first-in-human trial in ABCA4 retinopathy and to advance additional programs in neuromuscular, neurological, and rare disease indications. Read More
Bloomsbury Genetic Therapies Ltd. has raised £5 million (US$5.5 million) in a seed round, to take four gene therapy programs based on research carried out by the scientific founders at University College London into clinical development. Read More
Australia’s TGA has opened a consultation on drug-device combination products to help sponsors understand the regulatory pathway through which their products will likely pass since these combination products may not fit within existing definitions for drugs, biologicals or medical devices. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Accutar, Albireo, Annovis, Arecor, Bergenbio, Bridgebio, Caring Cross, Dice, Eupraxia, Forge, NMD, Orexo, PDS, Redx, Regeneron, Sanofi, Sellas, Tilt, United. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB Science, Aquestive, Eligo, Gilead, Harm Reduction, Pharming, Rigel, Teraimmune. Read More
