The FDA’s ability, or lack thereof, to churn out guidances is not always the stuff of industrial outrage, but manufacturers of laser-assisted in situ keratomileusis (LASIK) systems might find the timing of a new draft guidance on the procedure somewhat odd. The draft guidance arrives nearly a decade and a half after an April 2008 advisory hearing.
Terumo Blood and Cell Technologies (Terumo BCT) is teaming up with Eliaz Therapeutics Inc. to develop and commercialize a new type of apheresis treatment for acute kidney injury (AKI) and sepsis-induced acute kidney injury (S-AKI). The exclusive collaboration aims to reduce long-term morbidity and death in patients with AKIs by removing an upstream inflammatory protein called Galectin-3 (Gal-3) from blood plasma.
It is now possible to look up the 3D structure of every known protein following the latest release of Alphafold, an open database run in partnership by Deepmind, the London-based artificial intelligence company owned by Google parent Alphabet and the European Molecular Biology Laboratory’s European Bioinformatics Institute in Cambridge, U.K.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Dyansys, Lenstec.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Framatome, Gestalt Diagnostics, Global Morpho Pharma, Nano Precision Medical, Second Sight Medical Products, Vistapath.