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PDUFA VI: Industry Ready For 'Hard Sell' To Keep Agreement Intact

 
• By Sue Sutter

Biopharma industry is preparing for the unwelcome possibility that the new Congress and Trump Administration will seek to revisit provisions in the negotiated agreement for the US FDA user fee program's reauthorization.

Capitol House

The innovative biopharma industry is ready to lobby the new Congress and incoming Trump Administration for enactment of drug user fee legislation in 2017 in a way that does not disturb the carefully negotiated agreement with FDA.

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Switzerland Simplifies Imports Of Unauthorized Drugs To Tackle Drug Shortages

 
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EU ‘Can’t Expect Industry To Give Up Proprietary Insights’ Under Health Data & Clinical Trials Regulations

 
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340B Not Designed To Pass Savings Directly To Patients, Hospitals Tell Senate Committee

 
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Respondents to a Senate investigation that could re-energize 340B reform efforts said hospitals offer patient assistance programs and use 340B revenue for “capital improvement projects” and “community benefit programs,” though they do not account for specific program revenue allocations.

Kiji CEO On EU HTA Regulation, Hospital Exemption And The Future Of ATMPs

 
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Miguel Forte, CEO of Kiji Therapeutics, tells the Pink Sheet why he is confident in the future of gene therapies, despite the global “turmoil” that is impacting investment in the industry and changes to the EU and US regulatory landscapes.

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Pink Sheet Podcast: Vaccine Review Political Interference, Missed Deadlines A Harbinger Of US FDA Problems?

 
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Switzerland Simplifies Imports Of Unauthorized Drugs To Tackle Drug Shortages

 
• By Eliza Slawther

Swiss authorities have introduced temporary measures that will make it easier for health care professionals to import medicines that are either not authorized or not available in Switzerland, which will particularly benefit pediatric drugs, in light of ongoing shortages.

EU ‘Can’t Expect Industry To Give Up Proprietary Insights’ Under Health Data & Clinical Trials Regulations

 
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Both the EU Clinical Trials Regulation and the European Health Data Space Regulation have the potential to improve harmonization and be highly valuable for industry – but the importance of protecting company data will be paramount, a life sciences consultant says.