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    [{"orgOrder":0,"company":"Nagourney Cancer Institute","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Identification of Alpelisib (BYL 719) as a Potential Treatment for Endometrial Cancers","therapeuticArea":"Oncology","highestDevelopmentStatus":"Preclinical","country":"","productType":"Small molecule","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Preclinical"},{"orgOrder":0,"company":"Novartis Pharmaceuticals Corporation","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Novartis receives Piqray\u00ae approval in Europe \u2013 the first and only targeted medicine for HR+\/HER2- advanced breast cancer with a PIK3CA mutation","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"July 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Novartis Pharmaceuticals Corporation","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Novartis Data Highlight Efficacy of Piqray\u00ae in HR+\/HER2- Metastatic Breast Cancer With a PIK3CA Driver Mutation Immediately Post-CDK4\/6i","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"December 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Kura Oncology","sponsor":"Novartis Pharmaceuticals Corporation","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Kura Oncology Doses First Patient in Phase 1\/2 Clinical Trial of Tipifarnib in Combination with Alpelisib in Head and Neck Squamous Cell Carcinoma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Kura Oncology","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Kura Oncology Announces Multiple Abstracts Accepted for Presentation at AACR Annual Meeting","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Novartis Pharmaceuticals Corporation","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA approves Novartis Vijoice\u00ae (alpelisib) as First and Only Treatment for Select Patients With PIK3CA-Related Overgrowth Spectrum (PROS)","therapeuticArea":"Rare Diseases and Disorders","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"April 2022","url1":"","url2":"","graph1":"Rare Diseases and Disorders","graph2":"Approved"},{"orgOrder":0,"company":"Novartis Pharmaceuticals Corporation","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New Novartis Data Show Piqray\u00ae Effectiveness Across Key Biomarkers in Patients With Hr+\/her2- Metastatic Breast Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Kura Oncology","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Kura Oncology Reports Preliminary Proof of Mechanism in Phase 1\/2 Clinical Trial of Tipifarnib Plus Alpelisib in Head and Neck Squamous Cell Carcinoma","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"}]

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              Kura Oncology

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              Kura Oncology Reports Preliminary Proof of Mechanism in Phase 1/2 Clinical Trial of Tipifarnib Plus Alpelisib in Head and Neck Squamous Cell Carcinoma

              Details:

              R115777 (tipifarnib), a potent, selective and orally bioavailable FTI, has received Breakthrough Therapy Designation for the treatment of patients with HRAS mutant HNSCC and is currently in a registration-directed trial (AIM-HN) in patients with this devastating disease.

              Lead Product(s): Tipifarnib,Alpelisib

              Therapeutic Area: Oncology Product Name: R115777

              Highest Development Status: Phase I/ Phase II Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable October 26, 2022

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              Novartis Pharmaceuticals Corporation

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              New Novartis Data Show Piqray® Effectiveness Across Key Biomarkers in Patients With Hr+/her2- Metastatic Breast Cancer

              Details:

              Result of retrospective biomarker analysis finding that different genetic mutation profiles in tumors harboring PIK3CA mutation did not affect treatment benefit with Piqray (alpelisib) plus fulvestrant in patients with HEGFR-2 negative advanced or metastatic breast cancer.

              Lead Product(s): Alpelisib

              Therapeutic Area: Oncology Product Name: Piqray

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable June 03, 2022

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              Novartis Pharmaceuticals Corporation

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              FDA approves Novartis Vijoice® (alpelisib) as First and Only Treatment for Select Patients With PIK3CA-Related Overgrowth Spectrum (PROS)

              Details:

              Approval based on real-world data from EPIK-P1 study, which showed patients treated with Vijoice (alpelisib) experienced reduction in the size of PROS lesions and improvement of PROS-related signs and symptoms.

              Lead Product(s): Alpelisib

              Therapeutic Area: Rare Diseases and Disorders Product Name: Vijoice

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable April 06, 2022

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              Kura Oncology

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              Kura Oncology Announces Multiple Abstracts Accepted for Presentation at AACR Annual Meeting

              Details:

              Zarnesta (tipifarnib), a potent, selective and orally bioavailable farnesyl transferase inhibitor, is currently in a registration-directed trial (AIM-HN) in patients with this devastating disease.

              Lead Product(s): Tipifarnib,Alpelisib

              Therapeutic Area: Oncology Product Name: Zarnesta

              Highest Development Status: Phase I/ Phase II Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable March 08, 2022

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              Kura Oncology

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              Kura Oncology Doses First Patient in Phase 1/2 Clinical Trial of Tipifarnib in Combination with Alpelisib in Head and Neck Squamous Cell Carcinoma

              Details:

              Combination of tipifarnib, a farnesyl transferase inhibitor with Novartis’ alpelisib, a PI3Kα inhibitor provide greater antitumor activity, relative to inhibiting either target alone. The combination has potential to address up to 50% of patients with HNSCC in KURRENT trial.

              Lead Product(s): Tipifarnib,Alpelisib

              Therapeutic Area: Oncology Product Name: Zarnesta

              Highest Development Status: Phase I/ Phase II Product Type: Small molecule

              Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable December 16, 2021

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              Novartis Pharmaceuticals Corporation

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              Novartis Data Highlight Efficacy of Piqray® in HR+/HER2- Metastatic Breast Cancer With a PIK3CA Driver Mutation Immediately Post-CDK4/6i

              Details:

              New data underscore efficacy of Piqray (alpelisib), even in those patients with a short treatment duration on prior CDK4/6i or with ESR1 mutations, biomarkers of endocrine resistance.

              Lead Product(s): Alpelisib,Fulvestrant

              Therapeutic Area: Oncology Product Name: Piqray

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable December 10, 2021

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              Novartis Pharmaceuticals Corporation

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              Novartis receives Piqray® approval in Europe – the first and only targeted medicine for HR+/HER2- advanced breast cancer with a PIK3CA mutation

              Details:

              Piqray is the first and only treatment specifically approved for people with advanced breast cancer whose tumours harbor a PIK3CA mutation, which stimulates tumour growth and is associated with poor response to therapy.

              Lead Product(s): Alpelisib,Fulvestrant

              Therapeutic Area: Oncology Product Name: Piqray

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable July 29, 2020

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              Nagourney Cancer Institute

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              Identification of Alpelisib (BYL 719) as a Potential Treatment for Endometrial Cancers

              Details:

              Investigators at Nagourney Cancer Institute will report at the AACR Virtual Annual Meeting, June 22-24, that Alpelisib (BYL 719) may have an important role in the treatment of advanced uterine cancer as well as a number of other tumor types.

              Lead Product(s): Alpelisib

              Therapeutic Area: Oncology Product Name: BYL 719

              Highest Development Status: Preclinical Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable June 16, 2020

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              Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.
              ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
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