The European Commission has invested in several projects on novel real-world evidence methodologies, either via its key funding program for research and innovation or via public-private partnership initiatives.
With the emerging use of real-world data (RWD) and/or synthetic data in clinical trials to support safety and efficacy claims, the European Commission is keenly awaiting the first set of results from half a dozen projects it is funding to harness the use of such data for regulatory decision-making and health technology assessment (HTA).
The six projects were commissioned under Horizon Europe, which is the EU's key funding program for research and innovation. They...
The EU is testing a groundbreaking “all-in-one” process for reviewing combined drug and diagnostic trials via a single application for coordinated assessment.
Madrigal Pharmaceuticals’ resmetirom could become the first approved treatment for non-cirrhotic metabolic dysfunction-associated steatohepatitis in the EU, if the European Medicines Agency issues a positive opinion for the drug later this week.
The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.
Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.
Sarepta's rAAVrh74 vector, used in the marketed Duchenne muscular dystrophy gene therapy Elevidys and across the company's limb girdle muscular dystrophy pipeline, earned a platform designation as the lead LGMD candidate prepares for BLA filing.
Pink Sheet reporter and editors discuss the potential impact of the Most-Favored Nation drug pricing proposal on Europe, the United States, as well as the pharmaceutical industry.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
