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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Jul 21, 2025 – Jul 25, 2025)  

This week, PharmaShots’ news was all about the updates on clinical trials, Regulatory, Pharma, MedTech, M&A, DigiHealth, Animal Health and Biosimilars. Check out our full report below:  AstraZeneca Reports P-III (FLAURA2) Trial Findings on Tagrisso Regimen to Treat EGFRm NSCLC  Read More: AstraZeneca  Sun Pharma Reports Topline Data from P-III (INSPIRE-1 & INSPIRE-2) Trials of…
July 25, 2025

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NEWS

The EC Approves Fresenius’ Conexxence and Bomyntra (Biosimilars, Prolia & Xgeva)

Shots: The EC has approved Conexxence & Bomyntra, biosimilar versions of Prolia & Xgeva (denosumab) Approval covers all indications of the reference products incl. osteoporosis in postmenopausal women & men at high risk of fracture, SRE prevention in adults with bone-involved malignancies, giant cell tumors of bone & treatment-related bone loss Additionally, Fresenius & Amgen…
July 23, 2025

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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Jul 14, 2025 – Jul 18, 2025)   

This week, PharmaShots’ news was all about the updates on clinical trials, Regulatory, Pharma, MedTech, M&A, DigiHealth and Biosimilars. Check out our full report below: Takeda Reports P-III (FirstLight & RadiantLight) Trials Data on Oveporexton for Narcolepsy Type 1 (NT1) Read More: Takeda AstraZeneca Reports P-III (BaxHTN) Trial Results of Baxdrostat for Uncontrolled or Treatment Resistant…
July 18, 2025

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NEWS

Samsung Bioepis Collaborates with Harrow to Commercialize its Ophthalmology Biosimilars in the US

Shots: Samsung Bioepis has entered into a definitive agreement to grant Harrow exclusive commercial rights of its ophthalmology biosimilar portfolio incl. Byooviz, biosimilar to Lucentis (ranibizumab), & Opuviz, biosimilar to Eylea (aflibercept) in the US Byooviz has been available in the US through Biogen since its launch in Jun 2022. In Oct 2024, Biogen notified…
July 18, 2025

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NEWS

Biocon Biologics’ Kirsty (Biosimilar, NovoLog) Secures the US FDA’s Approval

Shots: The US FDA has approved Kirsty (100 units/mL), an interchangeable biosimilar of NovoLog (Insulin Aspart) to improve glycemic control in adults & pediatric pts with diabetes mellitus Approval was based on comprehensive analytical, non-clinical, & clinical data, which showed similar efficacy, safety, purity & potency of Kirsty vs NovoLog Kirsty is a rapid-acting human…
July 16, 2025

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WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Jul 07, 2025 – Jul 11, 2025)   

This week, PharmaShots’ news was all about the updates on clinical trials, Regulatory, Pharma, MedTech, M&A, and Biosimilars. Check out our full report below:   PulseSight Therapeutics Reports First Patient Dosing with PST-611 in P-I (PST-611-CT1) Trial for Dry AMD/Geographic Atrophy   Read More: PulseSight Therapeutics  BioAtla Presents Preliminary P-I Trial Data of BA3182 in Patients with…
July 11, 2025

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NEWS

Lupin Joins Forces with Zentiva to Develop TNF-Alpha Inhibitor Biosimilar

Shots: Zentiva has entered into a license & supply agreement with Lupin to commercialize Lupin's TNF-alpha inhibitor biosimilar across multiple global markets Zentiva will lead commercialization outside the US & Canada, mainly in EU & CIS, while Lupin will handle development, manufacturing, & supply in agreed territories & commercialization in the remaining territories, incl. the…
July 9, 2025

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Celltrion
NEWS

Celltrion Launches Osenvelt and Stoboclo (Biosimilars, Xgeva and Prolia) in the US

Shots: Celltrion has launched Osenvelt & Stoboclo, biosimilar versions of Amgen’s Xgeva & Prolia (denosumab) in the US Stoboclo (60mg/mL) treats postmenopausal women & men with osteoporosis at high fracture risk, glucocorticoid-induced osteoporosis in both sexes, & increases bone mass in men on androgen deprivation therapy for nonmetastatic prostate cancer & women on adjuvant aromatase inhibitors…
July 8, 2025

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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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