Skip to content Skip to footer
Subscribe Now

NEWS

Xbrane Biopharma and Intas Pharmaceuticals Join Forces to Develop Biosimilar of Opdivo (Nivolumab) 
Shots:  Xbrane and Intas have entered into a global licensing and co-development agreement for Xbrane's biosimilar of Opdivo (nivolumab). Intas, through its Accord Healthcare, will commercialize the biosimilar, leveraging its oncology expertise and significant market presence in the EU  As per the agreement, Intas will fund and manage clinical as well as regulatory development, and…
November 19, 2024
Abbvie
AbbVie’s Elahere (Mirvetuximab Soravtansine) Receives the EC’s Approval to Treat Platinum-Resistant Ovarian Cancer 
    Shots:    The EC has approved Elahere to treat FRα+, Pt-resistant high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer after 1-3 prior treatments, valid across whole EU plus Iceland, Liechtenstein, Norway & Northern Ireland  Approval was based on P-III (MIRASOL) trial assessing Elahere vs investigator's choice of CT (weekly paclitaxel, pegylated liposomal…
November 18, 2024
BMS
BMS’ Augtyro (Repotrectinib) Gains the CHMP’s Positive Opinion to Treat Advanced ROS1+ NSCLC and NTRK+ Solid Tumors 
Shots:     The CHMP has granted positive opinion to repotrectinib for treating ROS1+ advanced NSCLC in adults and NTRK+ advanced solid tumors in patients (≥12yrs.), with the EC’s decision anticipated in Jan 2025  Opinion was based on P-I/II (TRIDENT-1 & CARE) trials, with TRIDENT-1 assessing repotrectinib in advanced solid tumors (NSCLC and tumors with ROS1 &…
November 15, 2024
InflaRx’s Gohibic (Vilobelimab) Gains the CHMP’s Positive Opinion for the Treatment of ARDS 
    Shots:    The CHMP has recommended Gohibic (under exceptional circumstances) to treat SARS-CoV-2-induced acute respiratory distress syndrome (ARDS) adults on systemic corticosteroids (SoC) & IMV (with/without ECMO), with the decision anticipated within 67days (Q1’24)  Opinion was backed by P-III (PANAMO) study of Gohibic vs PBO among invasively mechanically ventilated COVID-19 patients in ICU, showing improvement…
November 15, 2024
Sandoz
Sandoz Report the EC’s Approval of Afqlir (Biosimilar, Eylea) to Treat Neovascular Age-related Macular Degeneration (nAMD) 
Shots:  The EC has approved Afqlir(2mg vial kit & pre-filled syringe for intravitreal injection), biosimilar of Bayer’s Eylea (aflibercept), with the launch anticipated in Q4’25   Afqlir's biosimilar development program included analytical, preclinical & clinical data from the Mylight trial, establishing its equivalence in terms of efficacy & safety to the reference medicine  Aflibercept is a…
November 15, 2024
Load more