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Interferon-Free Hepatitis C Regimens Within Reach

 
• By Shirley Haley

Much of the hep C wish list was on display at the American Association for the Study of Liver Disease meeting in Boston Nov. 10-13 – all-oral interferon-free drug combinations for hepatitis C, regimens that don’t require ribavirin, and the possibility of a one-pill, once-a-day cure – demonstrating the Gold Rush mentality in the hep C space as drug makers race to put the pieces together and grab a share of a burgeoning market.

The quest for the optimal therapeutic regimen to cure hepatitis C boils down to safety, simplicity and efficacy in hard-to-treat populations, and researchers presenting data on behalf of pharmas in the thick of the race lined up to report their findings at the American Association for the Study of Liver Disease meeting in Boston Nov. 10-13.

The goal is to safely eliminate interferon from standard of care while cutting down the pill count and eradicating the...

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UK Looks To Auto-Match NHS Patients With Clinical Trials To Boost Recruitment

 
• By Vibha Sharma

The UK government is making it easier for millions of people to participate in clinical trials and is boosting transparency around how studies are delivered across the National Health Service.

Global Guideline Signals ‘Paradigm Shift’ For Pregnant And Breastfeeding Women, Says EMA

 
• By Anabel Costa-Ferreira

The European Medicines Agency expects the International Council for Harmonization’s new guideline will help address the critical lack of data on the use of medicinal products in pregnant and breastfeeding populations.

BIO Notebook: MFN Pricing, Obesity R&D, US FDA’s Rare Disease Hub And Reaction To Review Program

 
• By Sarah Karlin-Smith, Mandy Jackson, and Alaric DeArment

Highlights from Day Three of the BIO International Convention include the realities of MFN pricing, AstraZeneca's R&D plans for obesity, the need for resources for the FDA's rare disease hub and reactions to the Commissioner's National Priority Review Voucher program.

Post-Approval, Real-Time Monitoring Will Help Approval Standards, US FDA’s Makary Says

 
• By Sue Sutter

The FDA will use electronic health records to “get eyes” on drugs immediately after approval, Commissioner Martin Makary told the DIA 2025 Global Annual Meeting. He also wants to reduce development time with better communication and new approval pathways.

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HTA Expert Warns Of Escalating Measures If Pharma Fails To Tame Prices

 
• By Francesca Bruce

Too many “uninformative” drug trials fail to justify the excessively high prices of many medicines, while there is too much evidentiary uncertainty in European pricing and reimbursement systems, warned Anja Schiel from Norway’s NOMA.

BIO Notebook: PRVs Need To Be A Priority, IPO Window Shut And Focusing On Gene Therapy Safety

 
• By Mandy Jackson and Sarah Karlin-Smith

Highlights from day one of the BIO convention include advice for firms hoping to go public, a call for companies to push the US Congress on rare disease priority review vouchers, and updates on next-generation gene therapies.

Post-Approval, Real-Time Monitoring Will Help Approval Standards, US FDA’s Makary Says

 
• By Sue Sutter

The FDA will use electronic health records to “get eyes” on drugs immediately after approval, Commissioner Martin Makary told the DIA 2025 Global Annual Meeting. He also wants to reduce development time with better communication and new approval pathways.