Latest from Eliza Slawther
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.
The European Medicines Agency wants feedback on a reflection paper that aims to address a lack of “uniformity” in cardiovascular toxicity endpoints in clinical trials for cancer drugs.
Using artificial intelligence in drug discovery and development could have huge benefits for companies, but a key challenge will be addressing how data is used to train AI tools and managing intellectual property issues, says Clifford Chance’s Stephen Reese.
