Gottlieb Distances Himself From Trump's User-Fee Heavy Budget

New FDA commissioner passes on defending president's budget proposal during House appropriations subcommittee hearing. With Congress disinclined to reopen user fee negotiations, Gottlieb instead focuses on his priorities for agency.

Capitol House

After several lawmakers had declared the Trump administration's budget proposal dead on arrival, US FDA Commissioner Scott Gottlieb danced around the subject of user fees in his first congressional testimony has head of the agency.

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Switzerland Simplifies Imports Of Unauthorized Drugs To Tackle Drug Shortages

 

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

 

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.

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

 

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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Switzerland Simplifies Imports Of Unauthorized Drugs To Tackle Drug Shortages

 

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

 

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.

How Tumult At US FDA Could Impact Merger and Acquisition Strategy

 

With review and development uncertainly increasing, "it’s going to take longer for certain targets … to progress to a place where they’ve been derisked enough that big pharma is ready to write a big check," said Andrew Goodman of Paul Hastings.