Biopharma sponsors are eagerly awaiting guidance on how to apply 'real-world evidence' to drug development and regulatory decisions. Recent workshops provide some clues about what is likely to be included in the first drafts.
US FDA officials appear most comfortable applying “real-world evidence” to the challenges of patient selection for clinical trials – rather than jumping ahead to using those data sources as a basis for a drug approval decision.
During a week of workshops focused on the theme of real-world evidence in mid-September, FDA officials repeatedly made the point...
The Health and Human Services Secretary made incorrect statements about the status of key industry priorities at a recent House hearing, which actually may be a good thing for drug sponsors.
Roche’s filing for Elevidys in the EU followed applications in Middle Eastern countries because those markets accept applications based on approval by the US Food and Drugs Administration.
Incentives for repurposed drugs proposed as part of the EU pharma reform package are a “great step forward,” but more recognition is needed from payers and regulators to leverage the benefits of these medicines, experts say.
The government has explained how to navigate the UK’s regulatory and market access funding mechanisms.
An ongoing proof-of-concept study by the European Medicines Agency testing the use of US-style standards for submitting non-clinical raw data in marketing applications has received positive feedback from both industry and regulatory assessors so far.
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Tepezza, Amgen's treatment for moderate to severe thyroid eye disease.
The US FDA will not be in its usual position as the first regulator to approve novel drugs, with only one of the six novel candidates on the July user fee calendar seeking its first approval worldwide in the US
