CDER turned in its 13th novel approval of 2022 on Friday the 13th, and other drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

Real-world evidence – and maybe even an opioid-sparing claim – will be part of Pfizer’s efforts to grow the CGRP space if its $11.6bn bid for Biohaven’s migraine assets goes through. Nurtec ODT (rimegepant) is the star, but pending fast-acting zavegepant could play a valuable supporting role.

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

Merck’s latest pneumococcal vaccine and Pfizer’s RSV vaccine notched new BTDs, along with Zambon’s inhaled antibiotic for non-CF bronchiectasis, Acer’s vascular Ehlers-Danlos syndrome drug and Dizal’s targeted lung cancer candidate.

French orphan specialist developed new assay for primary endpoint to show non-inferiority of its room temperature-stable salt of trientine, earning a broader FDA approval than generically available second-line trientine products.

US FDA closed out the month of April with two new molecular entity approvals that address underserved markets but carry some safety concerns.