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 Breakthrough Designation is granted to […]readmore
Tags : Boehringer Ingelheim
Shots: The FDA’s FT designation follows EMPA-KIDNEY study assessing Jardiance (10mg, qd) vs PBO in ~6000 patients with CKD. The study was initiated based on the results of EMPA-REG OUTCOME […]readmore
Shots: The FDA’s approval is based on P-III INBUILD study assessing Ofev (150mg, bid) vs PBO in 663 patients with chronic fibrosing ILDs with a progressive phenotype for 52wks. at […]readmore
1. Mount Sinai Signs a Multi-Year Collaboration with Harbour BioMed to Develop Novel Biotherapies for Multiple Cancer Indications and COVID-19 Published: Mar 06, 2020 | Tags: Mount Sinai, Signs, Multi-Year, Collaboration, […]readmore
Shots: The EMA’s CHMP has granted a positive opinion, recommending MAA for nintedanib to treat SSc-ILD in adults. The positive opinion is based on P-III SENSCIS study assessing nintedanib (150mg, […]readmore
1. Companion Medical’s InPen Diabetes Management System Receives the US FDA’s Approval for Fixed Dosing and Meal Estimation Published: Feb 28, 2020 | Tags: Companion Medical, InPen Diabetes Management System, Receives, […]readmore
Shots: Trutino to receive upfront, pre/ clinical milestones, regulatory and commercial milestones along with royalties on sales. Boehringer to get access for Trutino’s ODC platform to develop up to 3 […]readmore
WHO to Accelerate Global Research and Innovation Against Corona Virus Published: Feb 06, 2020 | Tags: WHO, Accelerate, Global, Research, Innovation, Against, Corona Virus 2. Curis Amends its Existing Collaboration […]readmore
Shots: The real-world data involves assessing of Spiriva Respima Inhalation Spray 1.25mcg + combination inhaled corticosteroid and long-acting beta2-agonist (ICS+LABA) vs increased dose of ICS+LABA or continuing high dose of […]readmore
Shots: The US FDA has approved Trijardy XR which includes Jardiance (empagliflozin), Tradjenta (linagliptin) and metformin hydrochloride extended-release to lower blood sugar in adults with T2D, along with diet and […]readmore