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              Asieris Pharmaceuticals

              • Development Update

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              CHINA China

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              Chinaplas 2020

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              Asieris Received China NMPA's Approval to Start a Global Phase III Clinical Trial for APL-1702 to Treat Cervical Precancerous Lesions (HSIL)

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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.

              Myovant Sciences

              • Development Update

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              UNITED STATES United States

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              Chinaplas 2020

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              Myovant Sciences Presents Additional Data on Relugolix Combination Therapy in Women with Uterine Fibroids and Ovulation Inhibition Study

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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).

              ObsEva

              • Development Update

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              SWITZERLAND Switzerland

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              Chinaplas 2020

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              ObsEva Announces Positive Results from two Phase 3 Studies, PRIMROSE 1 and 2, of Yselty® for the Treatment of Uterine Fibroids

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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.

              ObsEva

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              SWITZERLAND Switzerland

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              Chinaplas 2020

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              ObsEva and Yuyuan BioScience Technology Announce Submission of the Pre-IND Dossier for Nolasiban with the Chinese NMPA

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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.

              Daré Bioscience

              • Development Update

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              UNITED STATES United States

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              Chinaplas 2020

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              Daré Bioscience Reports Use of the Postcoital Test Study as a Predictor of Contraceptive Effectiveness by Biology of Reproduction

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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.

              Mayne Pharma

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              AUSTRALIA Australia

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              Chinaplas 2020

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              Mayne Pharma Announces FDA Filing Acceptance of New Drug Application for E4/DRSP in the US

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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.

              ObsEva

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              SWITZERLAND Switzerland

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              Chinaplas 2020

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              ObsEva Announces Publication of Data Showing Efficacy of Linzagolix in a Potential New Indication for Treatment of Adenomyosis

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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.

              Myovant Sciences

              • Development Update

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              UNITED STATES United States

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              Chinaplas 2020

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              Myovant Sciences Submits NDA to the FDA for Once-Daily Relugolix Combination Tablet for the Treatment of Women with Uterine Fibroids

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              Lead Product(s): Relugolix

              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 01, 2020

              Details:

              NDA is supported by positive data from two Phase 3 studies and a long-term extension study, demonstrating sustained reduction in heavy menstrual bleeding while maintaining bone health through one year.

              Mithra Pharmaceuticals

              • Development Update

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              BELGIUM Belgium

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              Chinaplas 2020

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              Mithra and Searchlight Pharma Announce Filing of New Drug Submission for Estelle® in Canada

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              Lead Product(s): Estetrol,Drospirenone

              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 May 20, 2020

              Details:

              Health Canada has accepted Searchlight Pharma's New Drug Submission for a novel combined oral contraceptive (COC) product. Innovative product candidate developed by Mithra containing the unique native estrogen Estetrol (E4) and drospirenone (DRSP).

              Myovant Sciences

              • Development Update

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              UNITED STATES United States

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              Chinaplas 2020

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              Myovant Sciences Provides Recent Updates From Phase 3 SPIRIT 2 and Phase 3 SPIRIT 1 study in women with endometriosis

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              Lead Product(s): Relugolix,Estradiol,Norethindrone Acetate

              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 May 18, 2020

              Details:

              Co-primary endpoints and six key secondary endpoints met in Phase 3 SPIRIT 2 study in women with endometriosis, with results from the Phase 3 SPIRIT 1 study expected this year.

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