Showing 1711 results
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Press release /In the real-world, Pluvicto™ showed 13.5 months median PFS in chemo-naïve patients with PSMA-positive mCRPCReal‑world evidence showed Pluvicto achieved longer PFS when initiated after one ARPI…
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Press release /ROSALIA study met primary endpoints, confirming proposed biosimilar denosumab matches reference product in terms of pharmacokinetics, pharmacodynamics, efficacy, safety and immunogenicity in…
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Press release /Sandoz and Just - Evotec Biologics announce partnership to develop and manufacture multiple biosimilars with an option for expansion Sandoz gains access to proprietary AI-driven technology platform…
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Press release /Submission supported by comprehensive analytical and clinical data package Denosumab indicated for treating variety of conditions including osteoporosis in postmenopausal women1,2 Sandoz…
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Press release /Submissions supported by comprehensive analytical and clinical data package including a Phase I PK/PD similarity study and the integrated Phase I/III ROSALIA clinical trialDenosumab is indicated for…
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Press release /
Sandoz reviewing options after Federal Circuit upholds lower court ruling in biosimilar Erelzi® case
Sandoz evaluating next steps, including potential appeal to US Supreme Court Ruling continues to prevent launch of important, affordable treatment option for US patients affected by chronic… -
Press release /Biosimilar Hyrimoz® (adalimumab) citrate-free high-concentration formulation (HCF) is now approved in the EU for use in all indications of reference medicine Humira®*HCF formulation adalimumab offers…
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Press release /If approved, will be first-of-a-kind biosimilar natalizumab in Europe, for use in all indications of reference biologic Positive CHMP opinion based on evidence from extensive analytical…
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Press release /Decision not to review Federal Circuit July 2020 ruling continues to prevent Sandoz launch of more affordable Erelzi treatment option for US patients Sandoz is disappointed US patients affected by…
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Press release /Sandoz is seeking approval of high concentration formulation (HCF) adalimumab for use in all indications of reference medicine Upon approval, HCF formulation will offer patients enhanced yet familiar…