Adaptive Pathways: Companies Advised To Consider Hurdles As EMA Accepts More Applications
The European Medicines Agency has released its keenly awaited final report on it adaptive pathways pilot and says it will continue to accept applications for the new drug development concept. Meanwhile, law firm Bristows highlights the hurdles ahead for applicants.
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Emerging standards for regulatory use of RWE should resist the temptation to impose the standards and expectations of randomized clinical trials to a fundamentally different kind of evidence, Dreyer cautions.
The first marketing authorizations under the European Medicines Agency’s hotly debated adaptive pathways concept for getting drugs to patients faster could be granted in just a few years’ time.
Two-year-old biotech Mereo BioPharma Group plc is planning to start a pivotal Phase IIb study in osteogenesis imperfecta patients in the first-half of this year with its anti-sclerostin antibody, BPS-804, and if the results are promising, EU patients could gain early access through the region’s adaptive pathways program.