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Cures 2.0 May Get Fast Tracked Due To COVID-19

 
• By Sarah Karlin-Smith

Follow-up bill to the 21st Century Cures Act looks to be more focused on reimbursement and delivery than the 2016 law, which centered on speeding drug development and approval. The bill's architects are working to get some of their provisions, including those around antibiotics, attached to the next COVID-19 relief legislation. 

Legislation on Direction Sign - Green Arrow on a Grey Background.
COVID-19 may give Cures 2.0 the push it needs to get over the finish line • Source: Shutterstock

Reps. Fred Upton, R-WI, and Dianna DeGette, D-CO, are exploring ways to include some of the ideas for their second iteration of the 21st Century Cures Act into legislation currently in the works to tackle the coronavirus epidemic, the pair said on call with reporters this week.

The bipartisan duo, which shepherded the 21st Century Cures Act into law in 2016 against the odds of getting any...

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Senate Bill Would Boost Oversight Of US FDA User Fee Program Following Trump Reorganization

 
• By Sarah Karlin-Smith

Senate appropriators also put FDA on notice regarding recent meetings and compliance with the Federal Advisory Committees Act, signal positive news on rare pediatric diseases, and offer hints of other agency areas they have close eyes on.

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EMA Backs Gilead’s Yeytuo And 13 Other Drugs For EU Approval But Rejects Three

 
• By Eliza Slawther and Neena Brizmohun

The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.

Lilly Wins EU Thumbs Up For Kisunla After EMA Reverses Rejection

 
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EMA Says ‘No’ To Roche/Sarepta’s Elevidys, US FDA Investigates Fourth Death

 
• By Eliza Slawther and Sarah Karlin-Smith

The European Medicines Agency recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy as the US reported another death in an Elevidys patient.