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Celltrion
NEWS

Celltrion Reports BLA Submission for CT-P47 (Biosimilar, Actemra) to the US FDA for Treating Rheumatoid Arthritis

Shots : Celltrion has submitted BLA to the US FDA seeking approval for CT-P47 in both IV and SC route of administrations based on the P-III study    The P-III study assesses the safety, efficacy, PK, and immunogenicity of CT-P47 vs Actemra for treating moderate to severe active rheumatoid arthritis with inadequate response to methotrexate…
January 28, 2024

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NEWS

Evive’s Ryzeneuta (efembalenograstim alfa) Receives the CHMP’s Positive Opinion for the Treatment of Neutropenia and Febrile Neutropenia

Shots: The CHMP has granted a positive opinion to Ryzeneuta (20mg, IV) based on its safety and efficacy evaluation results as compared to PBO The recommendation was made by CHMP for EC’s approval as medicinal product for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with…
January 26, 2024

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NEWS

Boan Biotech Highlights Clinical Updates for BA6101 (biosimilar, Prolia) and BA1102 (biosimilar, Xgeva) to Treat Various Indications 

Shots: The company has completed patient enrolment in P-III trial which evaluates the safety, efficacy, PK & immunogenicity of BA6101 & BA1102 vs reference drugs (Prolia & Xgeva) for the treatment of various indication across Europe, United States & Japan  Boan also conducted a meeting in Germany to highlight the PK results from the…
January 15, 2024

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NEWS

STADA and Alvotech’s Uzpruvo (Biosimilar, Stelara) Obtains EC’s Approval for Immune-Mediated Diseases

Shots :  Followed by the CHMP’s positive opinion in Nov 2023 for Crohn’s disease, psoriasis and psoriatic arthritis, the EC has approved Uzpruvo across the EU and Iceland, Liechtenstein, and Norway  The approval was based on the analytical & clinical results, data from the study (AVT04-GL-301) comparing the safety and efficacy of AVT04 vs Stelara…
January 10, 2024

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NEWS

Bayer and Regeneron Receive the EC’s Approval for Eylea (aflibercept, 8mg) for the Treatment of Age-related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME)

Shots: The approval was granted based on the results from the P-III (PULSAR) & P-II/III (PHOTON) clinical trials evaluating the safety & efficacy of Eylea 8mg vs 2mg dosed Q8W following initial monthly dosing in patients (N=1,164) with nAMD & DME. The 1EP of both the studies was non-inferior BCVA changes Both the studies met…
January 8, 2024

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Ligand
NEWS

Ligand Pharmaceuticals’ Zelsuvmi Receives the US FDA’s Approval for the Treatment of Molluscum Contagiosum 

Shots:  Zelsuvmi (berdazimer topical gel, 10.3%) received the US FDA’s approval as a novel drug for the treatment of molluscum infections in adults & pediatric patients aged ≥1yrs. Zelsuvmi is expected to be commercially available in the US by H2’24  The company evaluated the safety & effectiveness of the US FDA-approved Zelsuvmi in P-III clinical…
January 8, 2024

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NEWS

Coherus BioSciences to Divest its Ophthalmology Franchise to Sandoz for $170M Up Front 

Shots : Coherus signs an agreement with Sandoz to divest its ophthalmology franchise which includes a lead asset Cimerli (ranibizumab-eqrn) along with its supporting commercial infrastructure  As per the terms of the agreement, Coherus will receive an all-cash consideration of $170M as up-front payment along with an additional amount for Cimerli product inventory &…
January 4, 2024

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