US FDA Gets Wanted Pathogen Program, Manufacturers Get Longer BARDA Contracts In Competing Pandemic Prep Bills

Key House and Senate committees advanced reauthorizations of the Pandemic All-Hazards Preparedness Act. It is unclear whether new perks for the FDA and drug makers will survive as the two chambers reconcile a myriad of differences between their plans. 

Earth surrounded by various pathogens
The Senate HELP Committee and the House Energy and Commerce Committee advanced pandemic prep bills 20 July and 19 July, respectively. • Source: Shutterstock

A Senate committee cleared a US Food and Drug Administration-requested pathogen preparedness program 20 July that is intended to help the agency avoid a repeat of the stress caused by the COVID-19 pandemic.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Legislation

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

 
• By 

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.

French Bill Could Improve Clinical Research, But Further Action Is Required

 

France’s simplification bill is a “first step” to improving the country’s clinical research environment, but more could be done to drive decentralized trials and simplify processes, says Leem, the French pharmaceutical industry association.

New Medicines Pricing Proposals Would Mean More Uncertainty For Spanish Supply Chains

 

Proposals to reform Spain’s reference pricing system are out of whack with the national pharmaceutical strategy published in December, six industry associations have warned.

More from Pink Sheet

Pink Sheet Podcast: More US FDA Departures, Makary On Combined AE Database, ‘Conditional’ Approval

 

Pink Sheet reporter and editors discuss the most recent senior staff departures at the FDA and their impact on the agency, as well as Commissioner Martin Makary’s plans for a new approval pathway and a combined adverse event database as outlined in an interview with a podcast host.

Vertex’s Alyftrek For CF Among Six Orphans On Track For Pan-EU Approval

 

The European Medicines Agency has recommended 16 drugs for EU-wide approval, including Vertex’s cystic fibrosis drug Alyftrek and five other orphans.

Quotable: Top Experts On Policy Hot Topics

 

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.