Drug and biotech companies will face an emerging trend of outside interference on pending drug reviews at FDA. The events surrounding the final outcome of FDA's review of Bristol-Myers Squibb and Merck's diabetes drug muraglitazar (Pargluva) signal that outside medical centers and prominent researchers will voluntarily play a larger role in drug safety oversight in the future.
By Ramsey Baghdadi
It was so close. FDA had finished its review of Bristol-Myers Squibb Co. /Merck & Co. Inc. ’s type 2 diabetes drug muraglitazar (Pargluva). The agency’s Endocrinologic & Metabolic Drugs Advisory Committee voted almost unanimously to recommend approval of the drug. FDA issued an "approvable" letter asking for more cardiovascular safety data from ongoing or already completed studies, which sounded easy enough
EU-level joint clinical assessments conducted under the Health Technology Assessment Regulation need to be more flexible when it comes to evidence requirements, according to experts speaking at a gene and cell therapy conference.
Both the EU Clinical Trials Regulation and the European Health Data Space Regulation have the potential to improve harmonization and be highly valuable for industry – but the importance of protecting company data will be paramount, a life sciences consultant says.
The policy expectation that the model clinical trial agreements are used without modification is in line requests from industry and the NHS/HSC.
DIA Korea hears how multiple domestic and global factors are affecting the environment for clinical trials in South Korea, and what actions may be taken to address this.
With review and development uncertainly increasing, "it’s going to take longer for certain targets … to progress to a place where they’ve been derisked enough that big pharma is ready to write a big check," said Andrew Goodman of Paul Hastings.
The policy expectation that the model clinical trial agreements are used without modification is in line requests from industry and the NHS/HSC.
DIA Korea hears how multiple domestic and global factors are affecting the environment for clinical trials in South Korea, and what actions may be taken to address this.
