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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

Now It Really Is Personal: US FDA 'Rushing' To Develop Policy For 'Bespoke Therapies'

Recent cases of individual designed treatments have FDA playing a bit of catch up. The concept has been on the horizon, but now “bespoke therapies” are here.

Drug Approval Standards Gene Therapy

Gene Therapy In The Real World: Long-Term Follow Up Is Key – If Patients Are Willing

The first of what promises to be a wave of potentially curative gene therapies are coming to market. One of the challenges for sponsors will be how to deliver long-term outcomes data demanded by regulators and payors from patients who don’t have any reason to go to the doctor.

Gene Therapy Post Market Regulation & Studies

US FDA’s Record Tally Of NMEs Outpaces Ability To Issue Press Releases

US FDA may have set record for new drug approvals during 2018, but agency actually issued press releases highlighting approvals less often than it has in the past.
Approvals FDA

US FDA’s Most Unusual Advisory Committee

Agency's opioid response efforts have pushed advisory committee into unusual territory in recent years. But a two-day meeting to discuss potential labeling changes to recommend co-prescribing of the overdose reversal agent naloxone moved way beyond any of the conventional boundaries of committee meetings.
Neurology Pricing Debate

“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 In a new draft guidance, FDA offers some initial thoughts on safeguards to make hyperfast development pathways successful.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
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