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[{"company":"Menarini","sponsor":"Radius Health","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Menarini Group and Radius Health Announce Positive Phase 3 Topline Results from the EMERALD Trial Evaluating Elacestrant in Breast Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"ITALY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Menarini"},{"company":"Menarini","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Positive EMERALD Trial Results for Elacestrant Presented at San Antonio Breast Cancer Symposium 2021","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"ITALY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Menarini"},{"company":"Menarini","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Menarini Group and Radius Health, Inc. Announce Publication of Elacestrant Pivotal Phase 3 EMERALD Clinical Trial Data in The Journal of Clinical Oncology","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"ITALY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Menarini"},{"company":"Menarini","sponsor":"Radius Health","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Menarini Group and Radius Health, Inc. Present a Subgroup Analysis From the Elacestrant Pivotal Phase 3 EMERALD Clinical Trial at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"ITALY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Menarini"},{"company":"Menarini","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Menarini Group\u2019s Elacestrant Granted Priority Review by the U.S. FDA for Patients with ER+\/HER2- Advanced or Metastatic Breast Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"ITALY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Menarini"},{"company":"Menarini","sponsor":"Radius Health","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"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","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"ITALY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Menarini"},{"company":"Philogen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Philogen Receives Authorisation to Initiate New Study in France to Evaluate Nidlegy\u2122 in Several Nonmelanoma Skin Cancers","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"ITALY","productType":"Large molecule","productStatus":"New Molecular Entity","date":"February 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Philogen"},{"company":"Philogen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Philogen Announces the Completion of A Second Interim Analysis of Its Phase III Clinical Program with Nidlegy for The Treatment of Melanoma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"ITALY","productType":"Large molecule","productStatus":"New Molecular Entity","date":"January 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Philogen"},{"company":"Philogen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Philogen Announces Enrolment of 214 Patients in the Nidlegy\u2122 Phase III European Clinical Trial For the Treatment of Locally Advanced Melanoma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"ITALY","productType":"Large molecule","productStatus":"New Molecular Entity","date":"July 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Philogen"},{"company":"MolMed","sponsor":"AGC Biologics","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"AGC to Complete the Acquisition of MolMed on July 31, 2020","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"ITALY","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"July 2020","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"MolMed"}]

Menarini

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Menarini Group's Elacestrant Marketing Authorization Application Accepted for Review by the European Medicines Agency (EMA) for the Treatment of ER+/HER2- Advanced or Metas...

Details:

Elacestrant (RAD1901), if approved, would be the first oral selective estrogen receptor degrader (SERD) to be available for patients suffering from second-line (2L) and third-line (3L) ER+/HER2- advanced or metastatic breast cancer in the European Union.

Lead Product(s): Elacestrant

Therapeutic Area: Oncology Product Name: RAD1901

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Radius Health

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 19, 2022

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Menarini

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Menarini Group’s Elacestrant Granted Priority Review by the U.S. FDA for Patients with ER+/HER2- Advanced or Metastatic Breast Cancer

Details:

Submission supported by results from pivotal Phase 3 EMERALD study of RAD1901 (elacestrant) showing statistically significant efficacy over current standard-of-care (SOC) medications for both overall study population and patients whose tumors harbor an ESR1 mutation.

Lead Product(s): Elacestrant

Therapeutic Area: Oncology Product Name: RAD1901

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 10, 2022

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Philogen

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Philogen Announces Enrolment of 214 Patients in the Nidlegy™ Phase III European Clinical Trial For the Treatment of Locally Advanced Melanoma

Details:

Nidlegy (bifikafusp alfa) is combination of the immunocytokines L19IL2 and L19TNF, which is being developed as intralesional treatment for patients with advanced locoregional melanoma and non-melanoma skin cancers.

Lead Product(s): Bifikafusp Alfa,Onfekafusp Alfa

Therapeutic Area: Oncology Product Name: Nidlegy

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 25, 2022

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Menarini

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Menarini Group and Radius Health, Inc. Present a Subgroup Analysis From the Elacestrant Pivotal Phase 3 EMERALD Clinical Trial at the 2022 American Society of Clinical Onco...

Details:

Elacestrant (RAD1901), is an investigational selective estrogen receptor degrader (SERD), out-licensed to Menarini Group, which is being evaluated for potential use as a once daily oral treatment in patients with ER+/ HER2- advanced breast cancer.

Lead Product(s): Elacestrant

Therapeutic Area: Oncology Product Name: RAD1901

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Radius Health

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 06, 2022

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Menarini Group and Radius Health, Inc. Announce Publication of Elacestrant Pivotal Phase 3 EMERALD Clinical Trial Data in The Journal of Clinical Oncology

Details:

RAD1901 (elacestrant) is a selective estrogen receptor degrader (SERD), out-licensed to Menarini Group, which is being evaluated for potential use as a once daily oral treatment in patients with ER+/ HER2- advanced breast cancer.

Lead Product(s): Elacestrant

Therapeutic Area: Oncology Product Name: RAD1901

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 20, 2022

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Philogen

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Philogen Receives Authorisation to Initiate New Study in France to Evaluate Nidlegy™ in Several Nonmelanoma Skin Cancers

Details:

Nidlegy™, the combination of the two active principles bifikafusp alfa (L19IL2) and onfekafusp alfa (L19TNF), has already shown promising results in the intralesional treatment of patients with advanced melanoma and in BCC and cSCC in an ongoing Phase II study.

Lead Product(s): Bifikafusp Alfa,Onfekafusp Alfa

Therapeutic Area: Oncology Product Name: Nidlegy

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 17, 2022

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Philogen Announces the Completion of A Second Interim Analysis of Its Phase III Clinical Program with Nidlegy for The Treatment of Melanoma

Details:

Nidlegy, as a neoadjuvant was found to be well-tolerated and 149 out of the anticipated 214 patients have been safely treated in PIVOTAL phase III trial in melanoma patients with locally advanced, fully resectable metastatic cancer.

Lead Product(s): Bifikafusp Alfa,Onfekafusp Alfa

Therapeutic Area: Oncology Product Name: Nidlegy

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 13, 2022

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Positive EMERALD Trial Results for Elacestrant Presented at San Antonio Breast Cancer Symposium 2021

Details:

RAD1901 (Elacestrant) is a SERD, being evaluated for potential use once daily oral treatment in patients with ER+/ HER2- advanced breast cancer, studies showed that it reduced risk of progression or death by 30%.

Lead Product(s): Elacestrant

Therapeutic Area: Oncology Product Name: RAD1901

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 08, 2021

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Menarini Group and Radius Health Announce Positive Phase 3 Topline Results from the EMERALD Trial Evaluating Elacestrant in Breast Cancer

Details:

The trial results being statistically significant demonstrate a clinically meaningful improvement of PFS in the elacestrant group versus endocrine standard of care in patients previously treated with endocrine therapies and CDK 4/6 inhibitors.

Lead Product(s): Elacestrant

Therapeutic Area: Oncology Product Name: RAD1901

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Radius Health

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 20, 2021

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MolMed

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AGC to Complete the Acquisition of MolMed on July 31, 2020

Details:

Through the acquisition of Molmed, AGC will enter into the innovative gene & cell therapy field to expand its CDMO offering to the area where there is a strong imbalance between demand and supply of specific skills and production capacity worldwide.

Lead Product(s): Zalmoxis

Therapeutic Area: Oncology Product Name: Zalmoxis

Highest Development Status: Phase III Product Type: Cell and Gene therapy

Partner/Sponsor/Collaborator: AGC Biologics

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Acquisition July 27, 2020

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