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House ALS Bill Would Require US FDA ‘Action Plan’ – But Not Conditional Approval

 
• By Laura Helbling

US House of Representatives if moving forward with a bill to respond to advocacy from ALS patients for more attention from FDA. The bill focuses on planning and scientific support, not new pathways.

Washington DC Capitol dome detail with waving american flag
• Source: Shutterstock

FDA would be required to develop and implement a five-year “action plan” to foster development of new treatments for ALS and other rare neurological disorder under a bill that appears primed to move quickly through the House of Representatives.

ACT for ALS directs FDA to publish a five-year action plan within six months of the date of enactment,...

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• By Sue Sutter

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EU Biotech Act: Careful Drafting Needed To Protect SMEs From ‘Over-Regulation’

 
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How The EU Biotech Act Could ‘Level The Playing Field’ For SMEs

 
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While industry awaits specific details on the EU Biotech Act, Clifford Chance partner and life sciences legal expert Gunnar Sachs explains the key aims of the new legislation and discusses the potential benefits for biotech firms.

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NICE Breaks New Ground In England As Abiraterone Becomes First Generic Drug To Win Funding

 
• By Neena Brizmohun

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England’s NICE Defends Its Processes, But Recognizes ‘Tough’ Climate For Industry

 
• By Eliza Slawther

Sam Roberts, chief executive of England’s NICE, has defended the health technology assessment institute’s cost-effectiveness thresholds and the country’s ranking against other nations when it comes to market access, while acknowledging that the UK’s pharma ecosystem is “really tough.”

FDA Office of New Drugs Director Mary Thanh Hai Not Interested In CDER Director Job

 
• By Sue Sutter

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