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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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.
Opioids are cheap, but the economics of clinical practice, including the shift of care from inside the hospital to outpatient or ambulatory facilities, are creating new opportunities for Pacira BioSciences’ non-opioid treatments for pain. Improved reimbursement and increased usage among anesthesiologists are the biggest revenue drivers for the company’s two marketed products.