“Early and primitive” is a term frequently used to describe drug development for dry AMD in discussions with experts. Several companies have brought products to Phase II trials, but none has met the efficacy endpoints. A new crop of start-ups is trying, driven by the huge unmet demand and emerging science.
With the eye-catching commercial success of new treatments for wet age-related macular degeneration, venture capital investors as well as industry players are turning their attention to the non-exudative form of the disease, dry AMD.
Genentech Inc./Roche has been remarkably successful in wet AMD with its drug Lucentis (ranibizumab), as has Regeneron Inc.’s Eylea (aflibercept),...
The former CDER director said she tells sponsors not to conduct an FDA-recommended study design or randomized trial if it will not work.
Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.
The UK government is making it easier for millions of people to participate in clinical trials and is boosting transparency around how studies are delivered across the National Health Service.
The European Medicines Agency expects the International Council for Harmonization’s new guideline will help address the critical lack of data on the use of medicinal products in pregnant and breastfeeding populations.
The UK government is making it easier for millions of people to participate in clinical trials and is boosting transparency around how studies are delivered across the National Health Service.
The European Medicines Agency expects the International Council for Harmonization’s new guideline will help address the critical lack of data on the use of medicinal products in pregnant and breastfeeding populations.
A differentiated profit-sharing model to accelerate the use of AI in drug development using clinical and patient data is being proposed in South Korea, but the idea faces multiple practical challenges
