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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.

Latest From Laura Helbling

Rx Vial Size: FDA Stresses Safety Issues Amid Push To Find Savings For Payors

There may be significant savings from eliminating wasteful packaging for high cost specialty drugs. The US FDA, however, is urging policy makers not to overlook the importance of patient safety in packaging issues.

Drug Safety Government Payers

New Tech Payment For Old Antibiotics: US Medicare Effort Brings Lots Of Interest

CMS streamlined process for enhanced payments is having an impact: seven antibiotic applications for New Technology Add-On Payment status in 2021—including one for a product that has been marketed for more than five years.

Infectious Diseases Reimbursement

Mandatory Efficacy Trials: US FDA Affirms Broad Scope Of New Post-Market Authority

Updated guidance on its authority to mandate postmarketing studies affirms that a new power to impose requirements to look for diminished efficacy reaches beyond the opioid drug class.

Post Market Regulation & Studies Guidance Documents

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
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