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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 In a new draft guidance, FDA offers some initial thoughts on safeguards to make hyperfast development pathways successful.
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.
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.
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As US FDA mulls how to make demonstrating interchangeability less burdensome, worries about the now-withdrawn guidance from biosimilar developers may offer some guideposts about where the agency will go.
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.
It's NTAP Season!
In a Pink Sheet podcast, Prevision Policy analysts discuss the US Medicare program's new technology add-on payment process.
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