In an interview at the European Association for the Study of Diabetes meeting, Merck exec Sam Engel explains the rationale behind the clinical trial strategy for the SGLT-2 inhibitor ertugliflozin, as it gears up with partner Pfizer for filings by the end of this year.
Results from the VERTIS SITA2 combination study for Merck & Co. Inc./Pfizer Inc.'s SGLT-2 inhibitor ertugliflozin will add to the range of trials that will support regulatory filings – a range the companies have kept broad with the aim of covering the broad spectrum of type 2 diabetes with the initial submission.
The partners aim to file the drug as a monotherapy as well as part of two fixed-dose combinations – with...
A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
Contract research organizations (CROs) in India must gear up to comply with new registration requirements coming into effect in April 2025 that aim to enhance the quality and integrity of clinical trials, as well as of any bioavailability and bioequivalence studies conducted by them.
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
Contract research organizations (CROs) in India must gear up to comply with new registration requirements coming into effect in April 2025 that aim to enhance the quality and integrity of clinical trials, as well as of any bioavailability and bioequivalence studies conducted by them.
The agency also should explain the potential consequences for sponsors if enrollment goals are not met, stakeholders say in comments on the DAP draft guidance. Some commenters urged the FDA to apply waiver criteria flexibly, especially for rare diseases.
