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Pazdur’s Tale Of Two Targeted Therapies

 
• By Sue Sutter

FDA’s oncology office director suggests Ariad’s ponatinib and ChemGenex’s Omapro represent the best and worst of times, respectively, in the quality of development programs for personalized medicines.

Offering his own version of Charles Dickens’ “A Tale of Two Cities,” FDA Office of Hematology and Oncology Products Director Richard Pazdur highlighted two real-world examples representing the best and worst of times in the quality of development programs for personalized cancer medicines.

Both therapies cited by Pazdur at a Sept. 14 conference on drug/diagnostic co-development are targeted at patients with chronic myelogenous...

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CAR-T REMS Removal Should Boost Access, But Long-Term Follow-Up, Black Box Remain

 
• By Sarah Karlin-Smith

The REMS removal and labeling changes should open up CAR-T treatment to many more US patients, although other regulatory hurdles and safety language that experts had wanted removed still stand.

America Next: Most Novel Agents With July Goal Dates Have Been Approved Overseas

 
• By Bridget Silverman

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

PDUFA VIII: Cutting Perceived Conflict Of Interest May Be A Theme

 
• By Derrick Gingery

Ongoing questions about user fees exerting too much influence over the FDA could spawn a shift in the PDUFA structure when talks begin later this year.

US CDC Vaccine Committee Revives Thimerosal Debate: A Portent Of Things To Come?

 
• By Bridget Silverman

The new Advisory Committee on Immunization Practices voted for new recommendations on the decades-old thimerosal safety issue and lays intellectual groundwork to revisit other past controversies and decisions.

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