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

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

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

Samsung Bioepis Report the CHMP’s Positive Opinion of Obodence & Xbryk (Biosimilar, Prolia & Xgeva)

Shots: The CHMP has granted a positive opinion to Obodence (60mg pre-filled syringe) & Xbryk (120mg vial), biosimilar versions of Prolia & Xgeva (denosumab), respectively Opinion was based on the P-I trial which confirmed PK equivalence between SB16, EU-DEN & US-DEN among healthy males (n=168), in terms of AUC from time zero to infinity &…

November 15, 2024

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

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

Meitheal Pharmaceuticals Receives Exclusive Commercial Rights of Three Biosimilars Across the US

Shots: Meitheal Pharmaceuticals & its parent, Hong Kong King-Friend Industry (HKF), have entered into an exclusive licensing agreement for commercializing biosimilars of pegfilgrastim & filgrastim in oncology and follitropin alpha for fertility treatment in the US Pegfilgrastim (SC, once per cycle) & filgrastim (SC, IV, daily for 14 days in CT treatment cycle) are bone…

October 31, 2024

Serum Institute of India Reports the CHMP’s Positive Opinion of Siiltibcy as a Diagnostic Aid for Mycobacterium Tuberculosis Infection

Shots: The CHMP has recommended Siiltibcy (0.5μg/mL rdESAT-6 & rCFP-10) to diagnose Mycobacterium tuberculosis infection in individuals (age: ≥28 days), valid in the EU plus Norway, Iceland & Liechtenstein. Separate MAA will be submitted to the UK MHRA Siiltibcy’s sensitivity & specificity was assessed in comparison with QuantiFERON TB Gold In-Tube test (QFT, in-vitro test)…

October 30, 2024

Iterum Therapeutics’ Orlynvah (Oral Sulopenem) Receives the US FDA’s Approval to Treat uUTIs

Shots: The US FDA has approved Orlynvah (sulopenem etzadroxil & probenecid) to treat uUTIs in adult women, specifically addressing infections caused by E.coli, Klebsiella pneumoniae, or Proteus mirabilis, particularly when there are few or no other oral therapy available Approval was based on two pivotal P-III studies (SURE 1 & REASSURE) that assessed the safety…

October 25, 2024

Alvotech and Teva Reports the US FDA’s Approval for the Additional Presentation of Selarsdi (Biosimilar, Stelara)

Shots: Alvotech and Teva have received the US FDA’s approval of Selarsdi’s new dosing presentation of 130mg/26mL (5mg/mL) solution in a single-dose vial for IV infusion for the same indications as Stelara (ustekinumab). It will be launched in the US during Q1’25 The US FDA, in Apr 2024, approved Selarsdi’s dosing of 45mg/0.5mL & 90mg/mL…

October 22, 2024

NEWS

BMS’ Augtyro (Repotrectinib) Gains the CHMP’s Positive Opinion to Treat Advanced ROS1+ NSCLC and NTRK+ Solid Tumors

InflaRx’s Gohibic (Vilobelimab) Gains the CHMP’s Positive Opinion for the Treatment of ARDS

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

Samsung Bioepis Report the CHMP’s Positive Opinion of Obodence & Xbryk (Biosimilar, Prolia & Xgeva)

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

Meitheal Pharmaceuticals Receives Exclusive Commercial Rights of Three Biosimilars Across the US

Serum Institute of India Reports the CHMP’s Positive Opinion of Siiltibcy as a Diagnostic Aid for Mycobacterium Tuberculosis Infection

Iterum Therapeutics’ Orlynvah (Oral Sulopenem) Receives the US FDA’s Approval to Treat uUTIs

Alvotech and Teva Reports the US FDA’s Approval for the Additional Presentation of Selarsdi (Biosimilar, Stelara)

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