Keeping Track: Targeted Oncologics Tepmetko, Ukoniq Cleared; Posimir Earns Opioid-Sparing Language
The latest US FDA approval news from the Pink Sheet’s US FDA Performance Tracker
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The sponsors of six drugs that are nearing the end of the regulatory review cycle in the EU could this week be asked to explain why the European Medicines Agency should recommend approving their products.
Company also withdraws Ukoniq, a P13K inhibitor, just 14 months after accelerated approval in two lymphoma indications. US oncology drugs panel will discuss safety concerns with the PI3K class on 21 April, but FDA has already staked out its position in a Lancet commentary that a new development approach is needed with survival as the ultimate safety endpoint.
Ahead of the usual flurry of deal-making in January, Roche gets retinal cell therapy candidate from Lineage Cell Therapeutics, Pfizer subsidiary Amplyx licenses antiviral candidate to Vera, and GSK expands neurology tie-up with Ligand.