Acute Lymphoblastic Leukemia Poised To Be First, Fast Driver Of CAR Immunotherapy
Given high complete response rates in early studies showcased at the American Society of Hematology’s recent annual meeting, acute lymphoblastic leukemia is a likely launch indication for chimeric antigen receptor immunotherapy. But while the results in B-cell malignancies are very promising so far, autologous CAR therapies are complex, and toxicities need to be carefully managed.
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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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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the potential consequences for sponsors if enrollment goals are not met, stakeholders say in comments on the DAP draft guidance.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.