BIEFFE MEDITAL SPA

The European Medicines Agency's European Shortages Monitoring Platform (ESMP) is now live, enabling marketing authorization holders to report medicine shortages in the EU. Mandatory use begins Feb. 2, 2025, with a full-functionality version releasing in Feb. 2025. ESMP aims to centralize and automate data collection on medicine shortages, improving prevention, monitoring, and management across the EU and EEA.

DFI, a microbiome research facility at UChicago, is set to begin clinical trials in January using bacteria strains manufactured at its new facility. These trials aim to address gut microbiome loss in hospitalized patients, particularly those undergoing severe medical conditions. The DFI, funded by the Duchossois family, secured FDA approval in April 2024 and has produced eight bacterial strains for the trials, with three already encapsulated. The trials will measure the impact of these strains on gut microbiomes and their retention.

Seven top pharma companies adopt PhaseV's ML technology for drug development, optimizing adaptive trials and precision medicine across various therapeutic areas.

Vera Therapeutics appoints Jason S. Carter as Chief Legal Officer, enhancing its team for the pivotal ORIGIN 3 trial of atacicept in IgAN, with topline results expected in Q2 2025 and a planned BLA submission to the FDA.

Article lists affiliations and funding sources for researchers in nephrology and critical care from various institutions, including University of Minnesota, University of Chicago, King’s College London, and University of Washington. Funding sources include Novartis, Bioporto, Biomerieux, NIH, and others.

Otsuka Holdings will pay ICU Medical $200 million upfront to enter the U.S. IV products market through a joint venture, aiming to address hurricane-related shortages. The partnership includes performance-based milestones and a backend put-call option, with ICU Medical's Austin plant transferring to the venture. Otsuka sees this as a way to introduce PVC-free technologies to a market with an established customer base, while ICU Medical CEO Vivek Jain highlights Otsuka's financial strength and commitment to portfolio expansion.

Spectral Medical delays FDA application for haemoperfusion device due to enrollment issues in pivotal trial, impacted by Hurricane Helene and medical supply chain disruptions, aiming for early 2025 completion.