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Beyond "Breakthrough": FDA, Industry See Benefits For Drugs Outside Expedited Pathway

 
• By Sue Sutter

Pharmaceutical manufacturers and FDA have enthusiastically embraced the “breakthrough therapy” program as a way to more quickly bring new drugs with substantial effects to patients in need. With two years of program experience now under their belts, agency and industry representatives talk about learnings and best practices that could be applied to the development and review of drugs outside the program.

FDA’s “breakthrough” designation has been the breakout star of the review changes ushered in under the last user-fee reauthorization. With enthusiastic adoption and positive reviews, stakeholders are eager to replicate the program’s success. The early experience with the breakthrough therapy program could serve as a model for transforming and improving the development and review of drugs and biologic products that do not carry the expedited regulatory pathway designation.

Pharmaceutical and biotechnology sponsors have enthusiastically embraced the breakthrough program. They have swarmed the agency with more than 200 requests for designation – a number far more than agency and...

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Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Eleanor Malone

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Early Development Deals: Ipsen's Strategy For Biomarker-Driven Success

 
• By Eliza Slawther

Mary Jane Hinrichs, Ipsen’s head of early development, talks to In Vivo about getting ahead of the competition by securing deals for candidates before they enter Phase I trials.   

Shape Our Content: Take The Reader Survey

 
• By Eleanor Malone

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in the coverage topics, content format or the method in which you receive and access In Vivo, or if you love it how it is, now is the time to have your voice heard.

In Partnership with Cerba Research

Prioritizing Safety in CAR-T Therapy: Patient Monitoring with Cerba Research’s Testing Portfolio

The cell and gene therapy (CGT) clinical trial landscape in general and CAR-T cell clinical trials in particular are a special focus for the FDA, EMA, and other regulatory agencies. The whole industry is thus aware of the recent FDA safety investigation and requirements for labeling CAR therapy products.

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The 360 Degrees Of European Biotech Financing In 2025

 
• By Jo Shorthouse

Almost halfway through 2025, and financing for European biotech could be described as challenging. Market volatility, geopolitical instability and trade barriers all loom large in biotech CEO minds when pitching for funding. In Vivo talked to biotechs and investors to gain a realistic view of the current market for company funding so far this year.

Rising Leaders 2025: Pedro Valencia’s ADC Vision At AbbVie

 
• By Jo Shorthouse

From chemical engineering to cancer innovation, AbbVie's rising oncology leader is advancing next-generation ADCs to tackle difficult-to-treat tumors with a patient-centered approach.

Leaders At The Frontier: Conversations From SynBioBeta 2025

 
• By David Wild

Mini-profiles of five synthetic biology companies and their leaders from SynBioBeta 2025 reveal how AI integration, data-driven platforms and interdisciplinary teams are revolutionizing drug discovery and manufacturing.