EMA Shortens Regulatory Path For Antibacterials Against Multidrug Resistant Pathogens
This article was originally published in The Pink Sheet Daily
Executive Summary
Following new guidance from the European Medicines Agency, marketing approvals for antibacterials against multi-resistant bugs could be granted in Europe on expanded Phase II clinical trial data, a path that multinational Roche is keen to explore.
You may also be interested in...
Pipeline Watch: Phase III Readouts For Dry Eye, Menopause
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
UCB And Microsoft Expand AI Tie-Up Beyond COVID-19
Two European pharmaceutical companies, UCB and Merck KGaA, are exploring artificial intelligence in different ways, the first for drug discovery and the second on a fundamental level.
Italfarmaco's Givinostat Encouraging In DMD, But Awaiting 2022 Pivotal Study Results
Italy’s Italfarmaco expects top-line data from its pivotal Phase III study of givinostat in Duchenne muscular dystrophy in the middle of next year, as the HDAC inhibitor continues to accrue data from the extension of its Phase II study.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: