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New medicines #7 — June 20, 2020 — June 26, 2020
A weekly overview of the development of new medicines.
- Allergan announced that the FDA issued a Complete Response Letter for the Biologics License Application (BLA) for Abicipar pegol for patients with neovascular (wet) age-related macular degeneration (nAMD):
- The letter from the FDA indicates that the rate of intraocular inflammation observed following administration of Abicipar pegol results in an unfavorable benefit-risk ratio
- https://www.biospace.com/article/fda-reject-s-allergan-s-abicipar-pegol-for-age-related-macular-degeneration/
- Acceleron presented results of their phase 2 trial of sotatercept in pulmonary arterial hypertension:
