Latest from Eliza Slawther
The trade association Medicines Australia has set out key priorities for the government’s upcoming budget announcement in light of worsening access to innovative medicines for Australian patients.
Sponsors are increasingly using Bayesian methods in clinical trials, prompting the European Medicines Agency to evaluate how it can address a lack of “clarity” around when this is acceptable.
The European Medicines Agency has recommended new uses for nine approved medicines, including Incyte's immunotherapy Zynyz which is poised to become the first EU treatment for squamous cell carcinoma of the anal canal.
If the EU’s controversial Artificial Intelligence Act applies restrictive rules to pharmaceutical research and development activities, the UK could benefit from offering a more favorable regulatory environment, top lawyer Stephen Reese explains.
The European Medicines Agency said that Sanofi’s Rezurock should be approved on a conditional basis for patients with chronic graft-versus host disease after reconsidering its initial decision not to recommend the drug.
Patients severely burned in a Swiss bar fire have been treated with a novel, life-saving antimicrobial containing sulbactam and durlobactam. But this drug has never been filed for approval in the EU, something that is “disappointing” according to the EMA’s Marco Cavaleri.
