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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
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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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NEWS

Alvotech Reports Topline Results from the Study of AVT06 (Biosimilar, Eylea) for Eye Disorders

Shots : The (AVT06-GL-C01) confirmatory trial investigated the efficacy, safety, and immunogenicity of AVT06 vs Eylea for the treatment of neovascular (wet) AMD   The results revealed that the trial met its 1EP of baseline to wk. 8 in Best-Corrected Visual Acuity (BCVA) showing therapeutic similarity between AVT06 and Eylea  AVT06, recombinant fusion protein, binds…
January 3, 2024

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