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Califf Says US FDA Ready If Human Avian Flu Infections Jump

 
• By Derrick Gingery

The FDA commissioner said an H5N1 vaccine can be developed from the same mRNA platform used to create the COVID-19 vaccines, but funds are needed to ensure production can begin quickly if a human outbreak occurs.

Robert Califf
FDA Commissioner Robert Califf spoke to Senators about the FDA's avian flu response during a hearing on the agency's FY 2025 budget request. • Source: Screenshot of Senate broadcast

Should the ongoing outbreak of avian influenza in US dairy cattle become a more widespread threat to humans, the US Food and Drug Administration can facilitate countermeasure development.

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Switzerland Simplifies Imports Of Unauthorized Drugs To Tackle Drug Shortages

 
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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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More from Pink Sheet

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.

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How Tumult At US FDA Could Impact Merger and Acquisition Strategy

 
• By Joseph Haas and Nielsen Hobbs

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.