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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Jun 30, 2025 – Jul 04, 2025)    

This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, and Biosimilar. Check out our full report below:  Neurocrine Reports Data From KINECT-HD Study Evaluating INGREZZA in Huntington’s Disease (HD)  Read More: Neurocrine  UCB Reports the P-III Data of Fenfluramine in CDKL5 Deficiency Disorder (CDD) Patients  Read More: UCB  …
July 4, 2025

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CuraTeQ
NEWS

The EC Approves CuraTeQ Biologics’ Dazublys (Biosimilars, Herceptin)   

Shots:  CuraTeQ Biologics, a subsidiary of Aurobindo Pharma, reported EC’s approval of Dazublys, its trastuzumab biosimilar following the CHMP’s recommendation in Apr 2025  The approval was based on its demonstrated similarity to Herceptin in PK, PD, efficacy, safety, and immunogenicity  Dazublys is approved for HER2-positive breast and gastric cancers, and expanding access to treatment across…
July 4, 2025

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NEWS

mAbxience Reports the EC’s Approval of Denbrayce and Izamby (Biosimilar, Xgeva and Prolia)

Shots: The EC has approved Denbrayce & Izamby, biosimilar versions of Amgen’s Xgeva & Prolia (denosumab) following the CHMP’s recommendation Denbrayce prevents skeletal-related events in adults with bone-involved malignancies & treats giant cell tumors of bone in adults & skeletally mature adolescents Izamby is indicated to treat osteoporosis in postmenopausal women & men at increased risk…
July 3, 2025

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NEWS

Apotex Receives Health Canada Approval for Aflivu (Biosimilar, Eylea)   

Shots:  Apotex has reported Health Canada's approval of Aflivu (aflibercept), a biosimilar to Eylea in PFS and vials  Aflivu is indicated for wet age-related macular degeneration, macular edema from retinal vein occlusion, diabetic macular edema, and myopic choroidal neovascularization  Aflivu expands Apotex's biosimilar portfolio, which already includes Grastofil (filgrastim), Lapelga (pegfilgrastim), and Bambevi (bevacizumab)  Ref: PRNewsWire | Image:…
July 2, 2025

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NEWS

Bio Usawa Biotechnology and Bioeq AG Partner to Expand Access to Vision-Saving Treatments Across Sub-Saharan Africa 

Shots:  Bio Usawa Biotechnology and Bioeq AG entered into an agreement to make ranibizumab biosimilar for serious retinal diseases, accessible to millions in Sub-Saharan Africa   The partnership gives Bio Usawa exclusive rights to register and market Bioeq’s ranibizumab biosimilar, BioUcenta, advancing access to essential biologics in Sub-Saharan Africa   BioUcenta, an intravitreal injection, blocks abnormal retinal…
July 1, 2025

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Fresenius Kabi
NEWS

Fresenius Kabi Launches Conexxence and Bomyntra (Biosimilars, Prolia & Xgeva) in the US 

Shots:  Fresenius Kabi launched Conexxence and Bomyntra, biosimilar of Prolia & Xgeva (denosumab) for all indications of the reference products across the US  Conexxence (denosumab-bnht) 60 mg/mL, available in PFS, is approved for adults at high risk of fractures, including those with osteoporosis, pts. on cancer treatments affecting bone density, or long-term glucocorticoids   Bomyntra (denosumab-bnht)…
July 1, 2025

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NEWS

Kashiv BioSciences and Amneal Pharmaceuticals Report Topline Results from the Study of ADL-018 (Biosimilar, Xolair) for CIU/CSU

Shots: Kashiv BioSciences has reported topline results of ADL-018, its proposed biosimilar to Xolair (omalizumab) for Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) unresponsive to H1 antihistamines. The BLA and MAA filings for the product are expected with the FDA and EMA, respectively, in Q4’25 The study met its 1EPs & 2EPs, demonstrating therapeutic equivalence and…
June 27, 2025

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