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Keeping Track: Three Oncologics, A New Migraine Preventive, And First LPAD Antibiotic Clear US FDA

 
• By Michael Cipriano, Bridget Silverman, and Mary Jo Laffler

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

Keeping Track Feature image

It's hard to keep the US regulatory and approval news brief this week: The Center for Drug Evaluation and Research’s novel agent approvals count for 2018 reached 41 with the approval of three new oncologics – Regeneron Pharmaceuticals Inc. and Sanofi’s Libtayo (cemiplimab-rwlc), Pfizer Inc.’s Vizimpro (dacomitinib) and Verastem Inc.’s Copiktra (duvelisib) – as well as Eli Lilly & Co.’s migraine preventative Emgality (galcanezumab-gnlm).

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FDA Leadership Shuffle Continues: Lowell Zeta Returns As OPDP, OGD Leaders Depart

 
• By Sue Sutter and Derrick Gingery

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• By Michael McCaughan

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Making EU Clinical Trials Regulation A Success ‘Takes All Of Us To Tango’

 
• By Eliza Slawther

Sponsors and regulatory agencies within the 27 EU member states must all be “committed” to working with the EU Clinical Trials Regulation in the most appropriate way to keep pace with other countries, including the UK where competition is heating up, says Miguel Forte, CEO of Kiji Therapeutics.