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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 major FDA reform outside of a user fee reauthorization package,...

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More from Legislation

EMA: ‘Sad To See’ Member States Against Patient Engagement Under EU Pharma Reform

 
• By Eliza Slawther

The European Medicines Agency’s chief medical officer Steffen Thistrup argued that patients are able to understand the “complex regulatory and scientific issues” that the EMA committees discuss when they assess drugs.

BIOSECURE Act Returning, Privacy, Gain-of-Function Bills Coming, Senate Sponsor Says

 
• By Laura Helbling

Legislation prohibiting work with certain Chinese biopharma firms will be reintroduced soon, Democratic Sen. Gary Peters said. And it will not be the only bill tied to international biotech competition and security concerns that will be considered.

Pharma DTC Ad Tax Break Targeted By US HHS, Congress

 
• By Derrick Gingery

Health and Human Services Secretary Robert F. Kennedy Jr. said a policy that would remove the tax write-off for pharma advertising expenses would be coming in a few weeks.

Korean Pharma Industry Proposes Policies As Election Nears

 
• By Jung Won Shin

As South Korea gears up for a snap presidential election, its biopharma industry proposes key desired policies to candidates, most of whom have not laid out detailed plans of their own for the sector.

More from Pink Sheet

EMA Says Digital Transformation A ‘Fundamental Shift’ In Meeting Regulatory Challenges

 
• By Eliza Slawther

Sponsors can expect faster evaluation processes for key medicines and greater support in mitigating medicines supply shortages this year as part of the European Medicines Agency’s digital transformation overhaul.

EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

HHS Rescinds COVID-19 Vaccine Advice, Usurping US CDC Role

 
• By Sue Sutter

By stepping into the role of the Centers for Disease Control and Advisory Committee on Immunization Practices, HHS Secretary Robert F. Kennedy Jr. is causing further confusion and uncertainty about vaccine policy, experts say.