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As Sickle Cell Gene Therapies Move To Market, Health Inequities Could Help Pricing Debate

 
• By Cole Werble

Positive tandem ICER reviews for bluebird bio’s and Vertex/CRISPR’s gene therapies show the impact that concerns about addressing racial inequities could create a favorable context for products as they enter pricing and coverage discussions.

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• Source: Shutterstock

Strong clinical benefit assessments by the Institute for Clinical and Economic Review’s California Technology Assessment Forum for both bluebird bio’s lovo-cel and Vertex Pharmaceuticals Incorporated/CRISPR Therapeutics AG’s exa-cel gene therapies for sickle cell disease presage smooth approval decisions by the US FDA for the two gene therapies at the end of 2023.

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Pipeline To Product – What Is Driving Cell And Gene Therapy Progress In India?

 
• By Vibha Ravi

US-based Colossal Labs has claimed to bring back the dire wolf from extinction. While the science is not as dramatic in India yet, cell and gene therapies are making progress as treatments for cancer and other diseases. Pink Sheet takes a look at what is driving CGT success and growth

Gene Therapy ‘Survival Of The Fittest’ – Why Companies Need To Understand Health Systems

 
• By Eliza Slawther

Cell and gene therapy manufacturers must consider the practicalities of their product within the context of a health care system before it comes onto the market to be successful, experts from Novartis, AstraZeneca and England’s National Health Service say.

Device-Like System Proposed For Low-Risk Human Cell Therapies, Tissue-Based Products At US FDA

 
• By Kate Rawson

A risk-based approach to human cell therapies and tissue-based products could incentivize development and prevent bad actors from taking advantage of the current FDA system.

US Approach To Cell And Gene Therapy Regulations ‘Less Strict’ Than EU

 
• By Eliza Slawther

Experts working in the advanced therapy space say the US has less strict criteria for regulatory pathways for cell and gene therapies than the EU, particularly for products in early development.

More from Advanced Technologies

Device-Like System Proposed For Low-Risk Human Cell Therapies, Tissue-Based Products At US FDA

 
• By Kate Rawson

A risk-based approach to human cell therapies and tissue-based products could incentivize development and prevent bad actors from taking advantage of the current FDA system.

US Approach To Cell And Gene Therapy Regulations ‘Less Strict’ Than EU

 
• By Eliza Slawther

Experts working in the advanced therapy space say the US has less strict criteria for regulatory pathways for cell and gene therapies than the EU, particularly for products in early development.

US FDA Under Makary: MAHA With A Lighter Touch

 
• By Michael McCaughan

US FDA Commissioner nominee Martin Makary is being embraced by industry, and Senate Democrats, as a more traditional pick than other Trump Administration nominees, but the Make America Healthy Again agenda still is clearly coming to the agency.