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Lead Product(s): L-Lactic Acid,Citric Acid,Potassium Bitartrate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: EVO100
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 October 07, 2020
Details:
AMPOWER was a single-arm, open-label Phase 3 study designed to evaluate the efficacy and safety of Phexxi™ (lactic acid, citric acid and potassium bitartrate) in preventing pregnancy.
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Lead Product(s): Ferrous Gluconate Anhydrous,Vitamin C
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Ovaprene
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Avomeen
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership September 01, 2020
Details:
Daré and Avomeen are currently collaborating on development-stage programs, including Ovaprene®, an investigational hormone-free, monthly contraceptive, and intend to expand their partnership to include more programs in Daré’s women’s health pipeline.
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Lead Product(s): Relugolix,Estradiol,Norethindrone Acetate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: MVT-601
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 17, 2020
Details:
Myovant's NDA for once-daily, oral relugolix combination tablet for the treatment of women with heavy menstrual bleeding associated with uterine fibroids has been accepted for review by the U.S. Food and Drug Administration (FDA).
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Lead Product(s): Photodynamic drug
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Cevira
Highest Development Status: Phase III Product Type: Undisclosed
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 08, 2020
Details:
Asieris has received Clinical Trial Approval from China NMPA for the global, multi-centered Phase III clinical trial of its photodynamic drug-device combination product Cevira®, which is being developed for the non-surgical treatment of high-grade cervical dysplasia.
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Lead Product(s): Relugolix,Estradiol,Norethindrone Acetate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: TAK-385
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 July 06, 2020
Details:
Data from Phase 3 LIBERTY program show improvement in patient-reported outcomes in addition to improvement in hemoglobin levels in anemic women after administration of relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg).
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Lead Product(s): Linzagolix,Hormonal add-back therapy
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Yselty
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 July 06, 2020
Details:
PRIMROSE 1 achieved statistically significant and clinically meaningful results across primary and key secondary endpoints at week 24. Results confirm linzagolix as a potential best-in-class GnRH antagonist.
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Lead Product(s): Nolasiban
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: OBE001
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Yuyuan BioScience Technology
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 01, 2020
Details:
Nolasiban, a novel, oral oxytocin receptor antagonist, is being developed for improving clinical pregnancy and live birth rates in women undergoing in vitro fertilization (IVF). Two Phase 3 studies have been completed in Europe.
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Lead Product(s): Ferrous Gluconate Anhydrous
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Ovaprene
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 June 24, 2020
Details:
Publication of a literature review article by Biology of Reproduction identifies and reviews 10 postcoital test studies of vaginal contraceptives involving 9 test products, including Daré’s Ovaprene, currently under a license agreement with Bayer.
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Lead Product(s): Estetrol,Drospirenone
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: E4/DRSP
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 June 24, 2020
Details:
New Drug Application (NDA) for E4/DRSP to prevent pregnancy has been accepted for review by the US Food and Drug Administration (FDA). The FDA is expected to complete its review in the first half of calendar 2021.
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Lead Product(s): Linzagolix
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Undisclosed
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 June 04, 2020
Details:
By week 12 of treatment with 200 mg linzagolix, the patient was amenorrheic (cessation of bleeding), her pelvic pain was substantially improved, anemia was resolved, and MRI showed marked shrinkage in uterine volume (to 290 cm3) with regression of adenomyotic lesions.
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