Edition:
India

Bavarian Nordic Announces Positive Results Of Pivotal Phase 3 Study Of Imvamune Smallpox Vaccine


Tuesday, 6 Feb 2018 

Feb 6 (Reuters) - Bavarian Nordic A/S ::BAVARIAN NORDIC ANNOUNCES POSITIVE RESULTS OF PIVOTAL PHASE 3 STUDY OF IMVAMUNE® SMALLPOX VACCINE.BLA FILING EXPECTED IN SECOND HALF OF 2018 WITH FAST TRACK DESIGNATION.SAYS ‍STUDY ACHIEVED BOTH OF ITS PRIMARY ENDPOINTS​.SECOND POSITIVE PHASE 3 DEMONSTRATING THE SAFETY AND EFFICACY OF IMVAMUNE AND FINAL STUDY REQUIRED FOR LICENSURE, AS AGREED WITH FDA.