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Keeping Track: Apadaz Approved Without Abuse-Deterrent Label, FDA Denies Translarna Appeal, And Some Priority Reviews

Executive Summary

The latest drug development news and highlights from our US FDA Performance Tracker.

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PTC Eyes Transition From Capital-Raising To Money-Making Company

With $1.1bn in cash plus revenue from its existing commercial products and royalties from Roche’s sales of newly approved Evrysdi to invest in R&D, PTC Therapeutics may achieve profitability in 2023.

Improved EU Patient Access & Reimbursement On The Cards For Translarna

Some reimbursement agencies in Europe have been misinterpreting Translarna’s label and stopping access to the drug for boys with Duchenne muscular dystrophy who have been taking it but whose disease has progressed, PTC says.

Keeping Track: AstraZeneca Wins Approval For Lumoxiti, AbbVie Expands Label For Venclexta With MRD Data, and FDA Delays Acorda's Inbrijia NDA

The latest drug development news and highlights from our US FDA Performance Tracker.

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