Category: Esbriet

PureTech challenges Roche’s Esbriet in head-to-head IPF trial

January 6, 2022 Auto Bot 0

Roche’s idiopathic pulmonary fibrosis (IPF) therapy Esbriet is already being squeezed by its main rival in the market, and could come under renewed pressure if […]

Insights+: Breakthrough Therapy Designation by the US FDA in 2020

March 11, 2021 Auto Bot 0

Breakthrough Therapy (BT) Designation is an expedited review program introduced in Section 902 of the Food and Drug Safety and Innovation Act of 2012 The […]

Roche Reports the US FDA’s Acceptance of sNDA and Granted Priority Review for Esbriet (pirfenidone) to Treat UILD

January 21, 2021 Auto Bot 0

Shots: The sNDA submission is based on a P-II study that involves assessing Esbriet vs PBO in patients aged ≥18-85yrs. with progressive fibrosing UILD for […]