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How To Save A Drug: Iressa’s Return Relied On Consistency Across Totality Of Evidence

 
• By Bridget Silverman

Drug Review Profile of the second life of AstraZeneca’s Iressa shows how FDA adapts to imperfect but improving information without putting undue burden on sponsors – and how the agency recently applied a similar iterative approach to another EGFR inhibitor, Astellas and Genentech’s Tarceva.

FDA met the unusual circumstances of AstraZeneca PLC’s Iressa (gefitinib) in a genetically defined non-small cell lung cancer population – a new frontline NDA for a withdrawn third-line product – with an unconventional approach to the evidence, agency review documents show. Faced with a circumstance where the gold standard of two well-designed randomized trials would not be forthcoming, FDA looked for consistency of signals across an accretion of data.

Reviewers recognized problems with the trials underlying Iressa’s approval for first-line treatment of metastatic NSCLC with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 substitution mutations, but...

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Potency Assay Issues Delayed US FDA Approval Of Mesoblast’s Ryoncil For Years

 
• By Sue Sutter

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Mesoblast’s Ryoncil: US FDA Changed Its Mind On Need For A Randomized Trial

 
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Testosterone, TRAVERSE, And A Label Change 15 Years In The Making

 
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HHS Rescinds COVID-19 Vaccine Advice, Usurping US CDC Role

 
• By Sue Sutter

By stepping into the role of the Centers for Disease Control and Advisory Committee on Immunization Practices, HHS Secretary Robert F. Kennedy Jr. is causing further confusion and uncertainty about vaccine policy, experts say.

EMA: ‘Sad To See’ Member States Against Patient Engagement Under EU Pharma Reform

 
• By Eliza Slawther

The European Medicines Agency’s chief medical officer Steffen Thistrup argued that patients are able to understand the “complex regulatory and scientific issues” that the EMA committees discuss when they assess drugs.

Autolus’s Aucatzyl And GSK’s Blenrep Among 10 New Drugs To Get EMA Nod

 
• By Vibha Sharma

The European Medicines Agency has OKd 10 new medicines for EU-wide approval, including a CAR-T therapy for treating acute lymphoblastic leukemia. Two drugs were, however, rejected.