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Open Trial Databases Not Widely Popular – Yet – Duke Researcher Finds

 
• By Derrick Gingery

For three major databases allowing researcher access to clinical trial data, few requests were to validate results.

Endpoint validation work may have to become part of a clinical trial's primary analysis plan as it is not popular among researchers using clinical trial data sharing portals – one of the somewhat disappointing implications of an analysis by Ann Marie Navar, of the Duke Clinical Research Institute.

Validation studies were among the primary reasons advocates demanded that sponsors make trial results available to researchers. A number of...

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Merck’s Keytruda Gains Medicare Negotiation Reprieve With Expanded Orphan Exemption

 
• By Cathy Kelly

Bristol Myers Squibb’s Opdivo and Merck's Welireg also could benefit from the delay in Medicare price negotiation process eligibility.

US FDA’s Biologics Center Departures Grew Before More Than 100 RIFs Exited

 
• By Derrick Gingery

The Center for Biologics Evaluation and Research saw departures far outnumber new hires in the second and third quarters of FY 2025, before more than 100 people left July 14 after the reduction-in-force was finalized.

US FDA Cancer Reviewers Heading For The Exits, Potentially Impacting Review Timelines

 
• By Sarah Karlin-Smith

US FDA's cancer drugs division is feeling the effect of drug reviewer departures, despite efforts to keep them at the agency.

Blenrep Review Highlights US FDA Oncology Trial Site Selection, Comparator Issues

 
• By Sue Sutter

The FDA will take a hard line on trial design and site selection to ensure applicability to the US, Oncology Center of Excellence Director Richard Pazdur said during a meeting on GSK's Blenrep.

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