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Find Drugs in Development News & Deals for NCGC00024928-23

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  • TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • SOLUTION;ORAL - EQ 20MG BASE/10ML

Details:

DARE-VVA1 (tamoxifen) is a small molecule vaginal insert acting as an Estrogen receptor modulator, which is being investigated for the treatment of moderate to severe dyspareunia.


Lead Product(s): Tamoxifen Citrate

Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: DARE-VVA1

Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 07, 2023

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DIACC3010 was well tolerated in monotherapy and potential biomarkers of pharmacological activity were seen in peripheral blood mononuclear cells and tumor tissues.


Lead Product(s): DIACC3010,Tamoxifen Citrate

Therapeutic Area: Oncology Product Name: DIACC3010

Highest Development Status: Phase IProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 06, 2023

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DARE-VVA1 is an investigational, proprietary formulation of tamoxifen for intravaginal administration with the potential to be a first-in-category treatment of VVA for women with or at-risk of HR+ breast cancer.


Lead Product(s): Tamoxifen Citrate

Therapeutic Area: Oncology Product Name: Undisclosed

Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 14, 2022

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Verzenio® abemaciclib is a targeted treatment known as a CDK4/6 inhibitor. Verzenio works inside the cell to block CDK4/6 activity and help stop the growth of cancer cells, so they may eventually die (based on preclinical studies).


Lead Product(s): Abemaciclib,Tamoxifen Citrate

Therapeutic Area: Oncology Product Name: Verzenio

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 28, 2021

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Based on results, Verzenio may require dose modification. Monitor patients for signs and symptoms of thrombosis and pulmonary embolism and treat as medically appropriate. Advise patients of potential risk to a fetus and to use effective contraception.


Lead Product(s): Abemaciclib,Tamoxifen Citrate

Therapeutic Area: Oncology Product Name: Verzenio

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Agilent Technology Inc

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 13, 2021

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Data from monarchE study for Verzenio® (abemaciclib), CDK)4/6 inhibitor used in combination with endocrine therapy used in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2) high risk early breast cancer abemaciclib).


Lead Product(s): Abemaciclib,Tamoxifen Citrate

Therapeutic Area: Oncology Product Name: Verzenio

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 27, 2021

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DARE-VVA1 is an investigational, proprietary formulation of tamoxifen for intravaginal administration with the potential to be a first-in-category treatment of VVA for women with or at-risk of HR+ breast cancer.


Lead Product(s): Tamoxifen Citrate

Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: DARE-VVA1

Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 23, 2021

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The Scottish Medicines Consortium has accepted Takeda’s PROSTAP 3 DCS (leuprorelin acetate) treatment for use in patients with early and advanced breast cancer, which is the most common cancer in women globally.


Lead Product(s): Leuprolide Acetate,Tamoxifen Citrate

Therapeutic Area: Oncology Product Name: PROSTAP 3 DCS

Highest Development Status: ApprovedProduct Type: Peptide

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 09, 2021

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Kisqali plus endocrine therapy had a median OS of nearly five years (58.7 months), the longest ever reported for premenopausal women with HR+/HER2- metastatic breast cancer (MBC), after a median of 53.5 months follow-up.


Lead Product(s): Ribociclib,Tamoxifen Citrate,Letrozole

Therapeutic Area: Oncology Product Name: Kisqali

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Astex Pharmaceuticals

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 09, 2020

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KISQALI® is the first CDK4/6 inhibitor to show statistically significant improvement in overall survival (key secondary endpoint) in advanced breast cancer in pre- and perimenopausal women.


Lead Product(s): Ribociclib,Tamoxifen Citrate,Goserelin Acetate

Therapeutic Area: Oncology Product Name: Kisqali

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Astex Pharmaceuticals

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 02, 2020

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Kisqali is the only CDK4/6 inhibitor, in combination with endocrine therapy, to achieve a perfect 5 out of 5 score, confirming substantial benefit for premenopausal women with HR+/HER2- advanced breast cancer, based on strong overall survival benefit in the MONALEESA-7 trial.


Lead Product(s): Ribociclib,Tamoxifen Citrate,Letrozole

Therapeutic Area: Oncology Product Name: Kisqali

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Astex Pharmaceuticals

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 21, 2020

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A final overall survival analysis showed that the addition of tamoxifen to abemaciclib demonstrated a median OS of more than 24 months with progression-free survival consistent to primary study results in patients with HR-positive, HER2-negative metastatic breast cancer.


Lead Product(s): Abemaciclib,Tamoxifen Citrate

Therapeutic Area: Oncology Product Name: Verzenio

Highest Development Status: Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 19, 2020

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