A greater investment in comparative effectiveness research appears inevitable, whether or not Congress creates a federally funded agency to conduct head-to-head trials. The Vytorin debacle is only the most recent reason why industry is wary. But there are steps pharma can take to prepare for the next big thing in health care policy. Despite Vytorin, Merck is one of the companies leading the way.
Kate Rawson
Merck & Co. CEO Richard Clark thinks comparative effectiveness research is the next big thing in pharmaceutical R&D.
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The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.
The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.
Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.
Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.
Pink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector.
The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.
