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Lung-MAP Patient Screening Should Translate To Cost-Savings

 
• By Derrick Gingery

Sponsors say the large number of biomarkers that will be searched for in candidates for the lung cancer trial should allow researchers to find patients much faster, and will offer cost-savings over traditional drug development.

The patient screening component of the newly launched Lung Cancer Master Protocol trial is expected to translate into significant cost-savings that is making the collaborative, multiple-drug “basket” design attractive to industry.

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More from United States

Moderna Pivots To Increase Focus On Cancer Amid US Vaccine Policy Changes

 
• By Joseph Haas

During its first quarter earnings call, Moderna avoided criticizing vaccine policy changes, but de-emphasized its flu/COVID-19 vaccine for those under age 50 and prioritized cancer programs.

What MAHA Means For US FDA: Prevention Is Not What You Think

 
• By Michael McCaughan

US HHS Advisor Calley Means said new pathways for root-cause treatments are part of the HHS Secretary Robert F. Kennedy Jr.’s vision for the FDA. But what most biopharma companies consider preventative medicines are not what he has in mind, nor does he seem to see those companies as part of the solution.

Makary’s Reorganization Decision A Turning Point For US FDA?

 
• By Michael McCaughan

US FDA Commissioner Martin Makary’s disavowal of a proposed reorganization plan may be an important turning point in the Trump Administration. The move does not improve the situation, but may mean the administration stops actively making things worse.

Pink Sheet Podcast: Vaccine Review Political Interference, Missed Deadlines A Harbinger Of US FDA Problems?

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors discuss FDA Commissioner Martin Makary’s decision to have one of his assistants lead negotiations for Novavax’s delayed COVID-19 vaccine review, as well as some recent missed review deadlines, which may be the result of recent FDA cuts.

More from North America