1. Pink Sheet

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

 
• By Michael Cipriano and Bridget Silverman

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

Keeping Track Feature image

The US FDA approved AstraZeneca PLC's CD22-directed cytotoxin Lumoxiti (moxetumomab pasudotox-tdfk), which became novel agent No. 36 backed by the Center for Drug Evaluation and Research (CDER) in 2018. It was also the first September approval for a novel drug, in what appears will be a quiet month compared with the recent and upcoming months.

AbbVie Inc. grew its label for Venclexta (venetoclax tablets) by adding minimal residual disease (MRD)-negativity data to the label as FDA prepares to release guidance on using MRD as...

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• By Francesca Bruce

In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.

ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
• By Vibha Sharma

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• By Anabel Costa-Ferreira

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