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Keeping Track: An Approval For Ajovy, A CRL For Ruconest, And Some Submissions from J&J

 
• By Michael Cipriano, Brenda Sandburg, and Bridget Silverman

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

Keeping Track Feature image

The US FDA's 2018 novel drug approval count continues to rise, with Teva Pharmaceutical Industries Ltd.'s preventative migraine treatment Ajovy (fremanezumab) joining the party as No. 37.

Pharming Group NV's hereditary angioedema (HAE) treatment Ruconest (C1 Esterase Inhibitor [recombinant]) didn't fare as well, however. The company...

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National Priority Voucher Gives US FDA Commissioner Tool For Radical Regulatory Surgery

 
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US FDA Commissioner Martin Makary will establish "national priorities" used to select sponsors for the pilot of “tumor board-style” drug reviews that would start before Phase III is completed.

Kisunla Back In The Spotlight As EMA Reconsiders Alzheimer’s Drug Rejection

 
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It appears that the European Medicines Agency is making progress on its re-examination of Eli Lilly’s Alzheimer’s disease drug Kisunla, following an initial rejection in March based on safety concerns.

Post-Approval, Real-Time Monitoring Will Help Approval Standards, US FDA’s Makary Says

 
• By Sue Sutter

The FDA will use electronic health records to “get eyes” on drugs immediately after approval, Commissioner Martin Makary told the DIA 2025 Global Annual Meeting. He also wants to reduce development time with better communication and new approval pathways.

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Brazil Could Look To Germany, UK And Australia For ATMP Drug Pricing Rules

 
• By Francesca Bruce

There is a place for using external reference pricing to set prices of advanced therapies, but any such mechanism must take into account the specificities of the Brazilian market and health system.

Lerodalcibep And First Generic Palbociclib Among 10 New EMA Filings

 
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Lerodalcibep and palbociclib are among the latest new drugs that the European Medicines Agency has started to review for potential EU marketing authorization.

Welireg Among Japan Recommendations; Economic Policy Raises Hopes Of Higher Prices

 
• By Lisa Takagi

Country recommends eights new drugs for approval, including six for rare diseases, and also announces macroeconomic policy the pharma industry says would enable some reimbursement prices to be raised.