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BIOTECHNOLOGY

Medical Device News Magazine reports breaking biotechnology news including new biotech developments, pharmaceuticals and more.

Acticor Biotech: Progress In Discussions with EU and US Regulatory Agencies

To date, the ACTISAVE study has enrolled more than 300 patients across 10 countries in the world. Out of them, 100 have been treated with thrombolysis with thrombectomy, reaching the target for the first futility analysis. The Independent Data Meeting Committee (IDMC) will gather in Q4 2023 to confirm safety and ascertain that preliminary results are aligned with the initial trial assumptions notes Acticor Biotech.

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Curium Receives Positive CHMP Opinion of PYLCLARI® for Primary Staging of Patients With High-Risk PCa Prior to Initial Curative Therapy and to Localize Recurrence of PCa in Patients With a Suspected Recurrence Based on Increasing Serum Prostate-Specific Antigen (PSA) Levels After Primary Treatment With Curative Intent

f approved for Europe, PYLCLARI® (INN: Piflufolastat (18F) formerly known as [18F]-DCFPyL) will offer prostate cancer patients access to a diagnostic imaging agent more sensitive than conventional imaging notes Curium.

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Menarini Group Shares New Analysis from EMERALD Clinical Study of ORSERDU® (Elacestrant) in Metastatic Breast Cancer at ASCO 2023

EMERALD Clinical Study is a Phase 3 registrational trial that demonstrated statistically significant PFS with elacestrant versus SOC endocrine monotherapy (fulvestrant, letrozole, anastrozole, exemestane). Based on these results, the U.S. Food & Drug Administration (FDA) approved ORSERDU (elacestrant) on January 27, 2023, for the treatment of postmenopausal women or adult men with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. 

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