Shots: The application is based on P-III CheckMate -648 study evaluating Opdivo (3mg/kg, q2w, IV) + Yervoy (1mg/kg, q6w up to 24mos.) or Opdivo + CT vs CT alone in […]readmore
Tags : ONO
Ascendis’ Skytrofa (lonapegsomatropin-tcgd) Receives the US FDA’s Approval for Pediatric Growth Hormone Deficiency Published: Aug 27, 2021 | Tags: Ascendis, Skytrofa, lonapegsomatropin-tcgd, US, FDA, Approval, Pediatric Growth Hormone Deficiency Amgen […]readmore
Seelos’ SLS-005 (Trehalose) Receives EC’s Orphan Drug Designation to Treat Amyotrophic Lateral Sclerosis Published: May 28, 2021 | Tags: Seelos, SLS-005, Trehalose, EC, Orphan Drug Designation, Amyotrophic Lateral Sclerosis The […]readmore
Shots: The approval is based on P-III CheckMate -743 study assessing Opdivo + Yervoy vs SOC Pt. based CT in patients with previously untreated unresectable malignant pleural mesothelioma The combination […]readmore
The year 2019 has been a busy year for global pharma and biotech companies involved in M&A, option & licensing agreements and gaining approvals. Our team has compiled a list […]readmore
1. Luye Pharma Reports Submission of NDA to the US FDA for LY03005 Published: Dec 26, 2019 | Tags: FDA, Luye Pharma, LY03005, NDA, reports, Submission, US 2. Immunomedics Reports […]readmore
Shots: The companies have submitted the sBLA for the combination therapy to expand its use as 1L treatment of unresectable, advanced/ recurrent NSCLC in Japan, for a partial change in […]readmore
Shots: ONO has submitted manufacturing and marketing approval application to MHLW for the treatment of WM an LPL in Japan The application is based on P-II ONO-4059-05 study assessing Tirabrutinib […]readmore
Shots: Bayer, BMS and Ono collaborate to evaluate the combination of Bayer’s Stivarga (regorafenib) with BMS & Ono’s Opdivo (nivolumab) vs regorafenib in patients with micro-satellite stable mCRC The collaboration […]readmore
Shots: Repare to receive $15M upfront, $160M milestones and royalties on sales of product from ONO. Repare to get exclusive development and commercialization rights for Repare’s Polθ Inhibitor Program in […]readmore