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Keeping Track: Merck's Winning Week; Novel Agents Submitted By GSK, Melinta, Portola

 
• By Bridget Silverman

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

FDA's Oct. 21 approval of Merck & Co. Inc.'s Zinplava brings to 19 the number of novel agents approved by CDER in 2016, a year that so far has seen a slower pace of new product approvals, with an upturn in complete response letters – a marked contrast to the past few years of record approval counts.

With two months remaining, 2016 has now passed the worst year of the 2000s for new molecular entity and novel therapeutic biologic approvals: 2007, when CDER cleared 18 novel agents

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More from Approvals

New EU Filings

 
• By Neena Brizmohun

Plozasiran, Arrowhead Pharmaceuticals' treatment for familial chylomicronemia syndrome, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

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

 
• By Sue Sutter

The company’s failure to show its potency assays measured attributes directly related to the mesenchymal stromal cell product’s therapeutic effect highlights the importance of a robust CMC program for complex cell therapies.

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

 
• By Sue Sutter

Agency staff repeatedly said the BLA based on a single-arm study in 55 patients lacked substantial evidence of effectiveness in steroid-refractory acute graft-versus-host disease and a randomized trial was needed, but changed course “based on additional consideration” after a second CRL.

Ryoncil Chronology: Three Review Cycles, Two CRLs, One Dispute Resolution Request

 
• By Sue Sutter

The Pink Sheet’s Drug Review Profile looks at the timeline for the clinical development and US FDA review of Mesoblast’s remestemcel for graft-versus-host disease.

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