Recent US FDA Breakthrough Therapy Designations, From Mass Market Vaccines To Rare Diseases
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.
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GlaxoSmithKline has just acquired a late-stage oncology asset, and sales of Shingrix are on the up again, but the outcome of its RSV vaccine study remains the main focus for 2022.
Pfizer will acquire ReViral for up to $525m, adding a Phase II antiviral for respiratory syncytial virus (RSV), complementing its own work to develop a vaccine.
US FDA Ups The Stakes In RSV Vaccine Race With Breakthrough Designations For Pfizer And Bavarian Nordic
New breakthrough therapy designations bolster Pfizer’s maternal RSV vaccine and Bavarian Nordic’s older adult program, while Sanofi/AstraZeneca prepare to submit nirsevimab BLA and GSK deals with fallout of safety-driven Phase III trial pause.