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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

Liposomal Drugs Should Not Be Compounded – Until Technology Catches Up

US FDA’s Pharmacy Compounding Advisory Committee agrees with AbbVie that liposomal drugs and products using hot melt extrusion should be listed as prohibited from compounding – but the panel also hopes to see technology advance to change that conclusion.

Advisory Committees Manufacturing

FDA Endocrinology Division To Be Led By Thanh Hai On Interim Basis; Guettier Leaving For Private Sector

Mary Thanh Hai ran the US agency's division for seven years before moving up in 2013; Guettier’s departure may provide an opportunity for CDER Director Woodcock to start to implement her vision for changes in the Office of New Drugs.

Drug Review Metabolic Disorders

Going Solo: Combo Products With Device But No Drug Sponsor To Get Hearing

US FDA seeking input on proposed approach to allow device sponsors to seek marketing authorization for a device labeled for use with a drug – even if the drug sponsor does not want to cooperate on the new use.

Combination Products Drug Approval Standards

Purdue Butrans Pediatric Study Added To Label – Sort Of

US FDA has updated the label for Purdue’s opioid pain therapy Butrans to note the existence of a pediatric study for the buprenorphine formulation. After consulting with its advisory committee, FDA didn’t include any further information.

Advisory Committees Approvals

CMS Explains “Newness” Criterion In Blincyto NTAP Discontinuation

Amgen’s argument that continuing the Medicare new technology add-on payment for Blincyto would allow for more data to be collected failed to persuade US CMS.

Government Payers Reimbursement

Demystifying Artificial Intelligence For Biopharma

As the amount of data increases, artificial or augmented intelligence is becoming an increasingly important tool for drug development. More pharma and biotech companies may need to get on board.

Research & Development Business Strategies
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