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Abbvie
NEWS

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

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Sandoz
NEWS

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

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Johnson& Johnson
NEWS

Johnson & Johnson’s Rybrevant Plus Lazcluze Receives the CHMP’s Positive Opinion as a 1L Treatment of EGFR-Mutated NSCLC

  Shots:      The CHMP has recommended Rybrevant + Lazcluze as a 1L treatment of NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations and approval of Type II extension of indication for amivantamab  Opinion was based on the P-III (MARIPOSA) study assessing Rybrevant + Lazcluze vs osimertinib & Lazcluze in NSCLC patients…
November 15, 2024

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NEWS

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

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BMS
NEWS

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

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Key Biosimilars Events of October 2024
INSIGHTS+

Key Biosimilars Events of October 2024

Shots:       Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency        Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients        The major highlights were the US FDA’s approval of Dong-A ST’s Imuldosa…
November 5, 2024

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Alvotech & Advanz Pharma
NEWS

Alvotech and Advanz Pharma Reports the EMA’s MAA Acceptance of AVT05 (Biosimilar, Simponi) 

Shots:  The EMA has accepted the MAA of AVT05, biosimilar version of J&J's Simponi & Simponi Aria (golimumab), for the treatment of several chronic inflammatory diseases, with the decision expected in Q4’25  Alvotech, in Apr 2024, reported top-line data from a confirmatory trial of AVT05 vs Simponi in patients with moderate to severe rheumatoid arthritis,…
November 4, 2024

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