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49 articles with Menarini Group
Menarini Group Presents Updated Results from Pivotal Phase 3 EMERALD Trial at the 2022 San Antonio Breast Cancer Symposium (SABCS)
The Menarini Group will present additional data from the Phase 3 EMERALD study (NCT03778931) of elacestrant, an investigational oral SERD, during the upcoming San Antonio Breast Cancer Symposium (SABCS) being held from December 6-10.
Karyopharm and Menarini Group Announce Orphan Medicinal Product Designation from the European Commission for Selinexor for the Treatment of Myelofibrosis
Karyopharm Therapeutics Inc., a commercial-stage pharmaceutical company pioneering novel cancer therapies, and the Menarini Group, a privately-held, leading international pharmaceutical company, announced that the European Commission has granted orphan medicinal product designation for selinexor for the treatment of myelofibrosis.
Menarini Group's Elacestrant Marketing Authorization Application Accepted for Review by the European Medicines Agency (EMA) for the Treatment of ER+/HER2- Advanced or Metastatic Breast Cancer
The Menarini Group, a privately held Italian pharmaceutical and diagnostics company, and Stemline Therapeutics, a wholly-owned subsidiary of the Menarini Group, announced that EMA has validated the Marketing Authorization Application for elacestrant, a selective estrogen receptor degrader, for patients with ER+/HER2- advanced or metastatic breast cancer.
Daiichi Sankyo and AstraZeneca report another first-in-class approval for Enhertu, Bayer snags an sNDA in metastatic hormone-sensitive prostate cancer and Merck faces contamination challenges with Januvia.
Menarini Group's Elacestrant Granted Priority Review by the U.S. FDA for Patients with ER+/HER2- Advanced or Metastatic Breast Cancer
The Menarini Group and Stemline Therapeutics, a wholly-owned subsidiary of Menarini Group, announced that the U.S. Food and Drug Administration has accepted the Company's New Drug Application for elacestrant, an investigational selective estrogen receptor degrader, for patients with ER+/HER2- advanced or metastatic breast cancer.
Menarini Group’s Elacestrant Granted Priority Review by the U.S. FDA for Patients with ER+/HER2- Advanced or Metastatic Breast Cancer
The Menarini Group and Stemline Therapeutics announced that the U.S. Food and Drug Administration has accepted the Company’s New Drug Application for elacestrant, an investigational selective estrogen receptor degrader, for patients with ER+/HER2- advanced or metastatic breast cancer.
Context Therapeutics and The Menarini Group Announce Clinical Trial Collaboration and Supply Agreement to Evaluate ONA-XR and Elacestrant Combination
Context Therapeutics Inc. and The Menarini Group announced a clinical trial collaboration and supply agreement for Menarini’s oral selective estrogen receptor degrader, elacestrant.
Menarini Silicon Biosystems and DIESSE announced strategic partnership to distribute CHORUS TRIO in North America
Menarini Silicon Biosystems Inc, a US company part of the Menarini Group and DIESSE Diagnostica Senese Società Benefit S.p.A. announced at the American Association for Clinical Chemistry Annual Scientific Meeting & Clinical Lab Expo that they have entered into a commercial agreement for the exclusive distribution of the CHORUS TRIO immunometric assay system in the United States of America.
Karyopharm and Menarini Group Receive Full Marketing Authorisation from the European Commission for NEXPOVIO® (selinexor) for the Treatment of Patients with Multiple Myeloma After at Least One Prior Therapy
Karyopharm Therapeutics Inc. and the Menarini Group today announced that the European Commission (EC) has granted Marketing Authorisation for NEXPOVIO.
With the submission of NDAs and BLAs, multiple companies are bidding for regulatory approval of drug candidates. BioSpace takes a look at several of the latest requests.
The Menarini Group and Radius Health, Inc. announced that Menarini, with support from Radius, has submitted a New Drug Application to the U.S. Food and Drug Administration for elacestrant in patients with ER+/HER2- advanced or metastatic breast cancer.
Biopharma and life sciences companies from across the globe provide updates on their businesses and pipelines.
Karyopharm and Menarini Group Enter into Exclusive License Agreement to Commercialize NEXPOVIO® (selinexor) in Europe and Other Key Global Territories
Menarini Group Obtains Exclusive Rights to Commercialize NEXPOVIO for the Treatment of Hematologic and Solid Tumor Oncology Indications in Europe (including the United Kingdom), Latin America and Other Key Countries.
Positive EMERALD Trial Results for Elacestrant Presented at San Antonio Breast Cancer Symposium 2021
The Menarini Group and Radius Health presented today at the San Antonio Breast Cancer Symposium (SABCS). The data was presented as a “Late Breaker” and shared in an oral presentation by Dr. Aditya Bardia, MD.
Menarini Receives FDA Orphan Drug Designation for SEL24/MEN1703, a first in class, dual PIM/FLT3 inhibitor for the Treatment of Acute Myeloid Leukemia
The Menarini Group announced that the U.S. Food and Drug Administration granted orphan drug designation to SEL24/MEN1703 for the treatment of Acute Myeloid Leukemia.
10/25/2021It was yet another busy week for clinical trial news. Here’s a look.
CHMP Adopted Positive Opinion for ELZONRIS (tagraxofusp), for the Treatment of Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
The CHMP recommended approval of ELZONRIS for the first line treatment of adult patients with BPDCN If approved by the European Commission, ELZONRIS will be the first approved treatment for patients with BPDCN, and the first approved CD123-targeted therapy, in Europe
Menarini Group and Radius Health Announce Global License Agreement for the Development and Commercialization of Elacestrant
Menarini licenses global development and commercialization rights of elacestrant, an oral SERD currently in late stage Phase 3 development
Study design presented at the ESMO World Congress on Gastrointestinal Cancer2020
Turnover reaches €3,793 million, with an increase of 3.2% compared to 2018 and EBITDA of €492 million thanks to continued strong performance of its most important products