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Laura Helbling

Laura Helbling is Director of Research at Prevision Policy and a Senior Writer at The RPM Report (now Pink Sheet). Laura has a degree in magazine journalism from the University of Missouri School of Journalism.
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Latest From Laura Helbling

“One Continuous Trial” In Oncology: US FDA Offers Guidance And Encouragement

One of the hallmarks of the “breakthrough” era has been the rapid expansion of first-in-human trials into pivotal studies for efficacy submissions. In a new draft guidance, FDA offers some initial thoughts on safeguards to make hyperfast development pathways successful.

 

Clinical Trials Research & Development

Paratek And The “Blockbuster” vs. Steady “Stewardship” Approach In Antibiotics

US FDA Antimicrobial Drugs Advisory Committee Chair Baden offers warning about “overuse” to emerging antibiotic sponsor.
Advisory Committees Infectious Diseases

PD-1 Fatigue: Cross-Labeling May Help Pare Checkpoint Inhibitor Pipeline

US FDA encouraging developers to embrace cross-labeling rather than continue separate development of proprietary PD-1 agents, but agency sounds eager for any other good ideas to pare back the number of checkpoint inhibitors in development. 

ImmunoOncology Drug Approval Standards

Interchangeability Comments From Biosimilar Sponsors Highlight Need For Flexibility, Challenges Of Postmarket Data Collection

As US FDA mulls how to make demonstrating interchangeability less burdensome, worries about the now-withdrawn guidance from biosimilar developers may offer some guideposts about where the agency will go.
Biosimilars Drug Approval Standards

More US FDA Departures: ODE II Director Rosebraugh, GI Division Director Griebel to Retire

FDA will have three leadership positions vacant in the Office of Drug Evaluation II when Curtis Rosebraugh leaves at the end of the month. 
FDA Leadership

It's NTAP Season!

In a Pink Sheet podcast, Prevision Policy analysts discuss the US Medicare program's new technology add-on payment process.

 

Medicare Reimbursement
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