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What Astellas Did Right In Using Real-World Evidence For Prograf Approval

 
• By Brenda Sandburg

US FDA’s John Concato cites rigorous collection of data and study design in getting Prograf lung transplant indication. Use of real-world evidence in Opdivo trials had mixed results, BMS exec notes.

victory dart
Astellas hits target with real-world evidence for Prograf indicaton • Source: Alamy

As companies increasingly seek to use real-world evidence to help gain approval of drugs, they want to know what it will take to satisfy the US Food and Drug Administration. An agency official offered insights on this in describing how Astellas Pharma, Inc.’s immunosuppressant Prograf (tacrolimus) got a lung transplant indication based on real-world data.

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More from RAPS

Model-Informed Drug Development Program Could Handle More Requests, But US FDA Needs Funding

 
• By Derrick Gingery

FDA is considering allowing MIDD meeting requests to be submitted more often than the current quarterly schedule, but agency must have a plan to deal with the likely increased demand, official says.

Woodcock Touts Baby Steps Toward Global Manufacturing Quality Dossier

 
• By Derrick Gingery

Focus of the campaign is the well-established pharmaceutical manufacturing sector, rather than cell and gene therapy production, the US FDA’s principal deputy commissioner said.

US FDA Solicits Comments On Barriers To Innovative Trial Design Implementation

 
• By Derrick Gingery

In admitting problems, the FDA creates a docket for comments and will convene a public workshop in the spring on why the clinical trial innovation is not more widespread.

Shutdown Threat Forced US FDA To Cancel Some Travel

 
• By Derrick Gingery

Several FDA staffers presented at the RAPS Convergence conference via Zoom and pre-recorded video instead, illustrating that just the threat of a shutdown can scramble FDA plans.

More from Pink Sheet

CSL Makes Landmark National-Level Pay-For-Performance Deal In Germany For Hemgenix

 
• By Francesca Bruce

A blanket pricing agreement CSL has formed with German health insurers for the gene therapy, Hemgenix, makes the cost of treatment budget-neutral compared to traditional treatment.

Japan Looks To Build Domestic Capacity In New Modalities

 
• By Lisa Takagi

Japan's trade ministry is providing new support to build domestic capacity for new modalities including cell and gene therapies, as part of wider efforts to support the national bioventure ecosystem.

GLP-1 Drug Coverage Growing For Obesity In Medicaid, But Only For Diabetes In Medicare

 
• By Cathy Kelly

Coverage data from the two programs suggest Medicare beneficiaries may be more disappointed than Medicaid enrollees by the Trump Administration’s decision not to mandate the programs cover obesity drugs.