RA drug development has been slow to revise the trial design paradigm despite agreement on the drawbacks of placebo controls and crossover elements, but FDA biostatistician Levin sees promise in non-inferiority designs.
The US Food and Drug Administration continues to promote the use of active-controlled, non-inferiority trial designs in rheumatoid arthritis, but sponsor uptake has not been enthusiastic, speakers indicated at a recent virtual summit sponsored by the FDA and the American College of Rheumatology.
Rheumatoid arthritis was one of the first indications to benefit from the evolution of the immunology pharmacopoeia from disease-modifying antirheumatic...
The Association of the British Pharmaceutical Industry says that while the government’s newly published Life Sciences Sector Plan includes many positive commitments, they are not enough.
Real-world data studies conducted by the European Medicines Agency increased by 48% according to its latest report on the topic, prompting the agency to consider how it can better integrate this type of evidence into regulatory decision-making.
In this second of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet which animal testing models have alternative options and highlights where further investment and research is needed to develop appropriate alternatives.
The Health Research Authority is working on a streamlined model for informed consent that maintains people’s trust.
The Health Research Authority is working on a streamlined model for informed consent that maintains people’s trust.
Akin to the 505(b)(2) NDA, a new biologic pathway could reduce the need for animal testing, FDA toxicologist says. Expanded use of generally accepted scientific knowledge (GASK), which few sponsors have attempted despite a 2023 draft guidance, would also help.
While the first six months of the year saw eight new drugs targeting a range of diseases enter the European Medicines Agency’s priority medicines scheme, and three PRIME-designated treatments go on to win EU marketing approval, use of the accelerated assessment mechanism appears to be limited.
