Bristol's filing of Yervoy/Opdivo in first-line lung cancer is delayed as the company drops its plans for accelerated approval, but could be on a more solid regulatory footing if the pivotal trial is successful. Meanwhile, AstraZeneca is using adaptive trial design to update MYSTIC, which could result in broader approvals.
Bristol-Myers Squibb Co.'s announcement that it will not seek accelerated approval of its Yervoy/Opdivo combination in first-line lung cancer has disappointed investors and seems to concede a significant edge to competitor Merck & Co. Inc., but it may make more sense from the regulatory perspective, giving the company a better chance for a successful filing.
Bristol announced Jan. 19 that it was not going to seek accelerated approval for the combination of its PD-1 inhibitor...
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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
Companies dealing with commercial costings or contracts with the National Health Service for early phase clinical trials or trials of advanced therapy medicinal products should soon be able to conclude their negotiations more quickly.
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the potential consequences for sponsors if enrollment goals are not met, stakeholders say in comments on the DAP draft guidance.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.
As the planet heats up and sea levels rise, the need to reduce carbon emissions is becoming ever more urgent. The life sciences industry is just one of many that are looking to cut the carbon it produces.
