Symbiotec Progesterone Symbiotec Progesterone

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[{"orgOrder":0,"company":"Knight Therapeutics","sponsor":"TherapeuticsMD","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Knight and TherapeuticsMD Announce Health Canada Approval of BIJUVA\u00ae","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Approved","country":"CANADA","productType":"Small molecule","productStatus":"Approved","date":"September 2020","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Approved"},{"orgOrder":0,"company":"SIFI","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"SIFI Initiates Patient Enrollment in Phase II Trial evaluating Pro-Ocular in Dry Eye Disease","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase II","country":"ITALY","productType":"Small molecule","productStatus":"Approved","date":"April 2021","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase II"},{"orgOrder":0,"company":"MedinCell","sponsor":"Bill & Melinda Gates Foundation","pharmaFlowCategory":"D","amount":"$22.5 million","upfrontCash":"Undisclosed","newsHeadline":"Additional US$ 4 Million Received for Next Development Steps of MedinCell's 6-Month Active Injectable Bioresorbable Subcutaneous Contraceptive","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Preclinical","country":"FRANCE","productType":"Small molecule","productStatus":"Approved","date":"November 2022","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Preclinical"},{"orgOrder":0,"company":"Dar\u00e9 Bioscience","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Dare Bioscience Initiates Phase 1\/2 Clinical Study of DARE-HRT1","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2022","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Pfizer CentreOne","sponsor":"Effik","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Pfizer CenterOne\u2019s Enviero\u00ae Receives First EU Authorization As Part of ESTIMA\u00ae (progesterone) Product Approval","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"November 2020","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Approved"},{"orgOrder":0,"company":"Dar\u00e9 Bioscience","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Dar\u00e9 Bioscience Announces Positive Efficacy Results from the DARE-HRT1 Phase 1 \/ 2 Study","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2022","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Dar\u00e9 Bioscience","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Dar\u00e9 Bioscience Announces Positive Pharmacokinetic (PK) Results from the DARE-HRT1 Phase 1 \/ 2 Study that Support the Potential of DARE-HRT1 as an Effective Hormone Therapy for Both Vasomotor and Vaginal Symptoms of Menopause","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"January 2023","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Dar\u00e9 Bioscience","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Dar\u00e9 Bioscience Announces Publication in Menopause: The Journal of The North American Menopause Society of Data from Phase 1 Trial of DARE-HRT1 that Support the Potential of DARE-HRT1 as an Effective Hormone Therapy for both Vasomotor and Vaginal Symptoms","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"January 2023","url1":"","url2":"","graph1":"Obstetrics\/Gynecology (Women\u2019s Health)","graph2":"Phase I\/ Phase II"}]

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            Details:

            Enviero is first-of-its-kind, a green-chemistry progesterone that represents a step change in progesterone API synthesis, is manufactured via a proprietary biocatalytic process based on plant sterols that reduce waste, greenhouse gas emissions and use of hazardous solvents.

            Lead Product(s): Progesterone

            Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Estima

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Effik

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 18, 2020

            Details:

            DARE-HRT1 (estradiol) acts on the on the estrogen receptors to relieve vasomotor systems (such as hot flashes) and urogenital symptoms (such as vaginal dryness and dyspareunia).

            Lead Product(s): Estradiol,Progesterone

            Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: DARE-HRT1

            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 January 26, 2023

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            Details:

            DARE-HRT1 (estradiol), is an investigational intravaginal ring, delivers bio-identical 17β-estradiol and bio-identical progesterone continuously for 28-day period. It has shown potential monthly-therapy for vasomotor and vaginal symptoms of menopause.

            Lead Product(s): Estradiol,Progesterone

            Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: DARE-HRT1

            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 January 09, 2023

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            Details:

            The Gates Foundation has a non-exclusive license on the product for the purposes of achieving Global Access in the target low-and middle-income countries, whilst MedinCell owns all marketing rights worldwide.

            Lead Product(s): Progesterone

            Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Undisclosed

            Highest Development Status: Preclinical Product Type: Small molecule

            Partner/Sponsor/Collaborator: Bill & Melinda Gates Foundation

            Deal Size: $22.5 million Upfront Cash: Undisclosed

            Deal Type: Funding November 30, 2022

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            Details:

            DARE-HRT1 has the potential to be the first FDA-approved product to offer vaginal delivery of combination bio-identical estradiol and bio-identical progesterone hormone therapy in a convenient monthly format.

            Lead Product(s): Estradiol,Progesterone

            Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: DARE-HRT1

            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 17, 2022

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            Details:

            DARE-HRT1 is a novel intravaginal ring designed to deliver bio-identical 17β-estradiol and bio-identical progesterone continuously over a 28-day period as part of a hormone therapy regimen to treat vasomotor symptoms and genitourinary syndrome associated with menopause.

            Lead Product(s): Progesterone,Estradiol

            Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: DARE-HRT1

            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 April 12, 2022

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            Details:

            ProGIFT is a multicenter, randomized, double-masked, placebo-controlled Phase II clinical trial comparing different concentrations of Pro-ocular (1% and 0.5%) versus placebo.

            Lead Product(s): Progesterone

            Therapeutic Area: Ophthalmology Product Name: Pro-ocular

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 27, 2021

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            Details:

            BIJUVA is a once-daily combination of estradiol and progesterone in a single oral capsule that will be available in two strengths in Canada indicated for the treatment of moderate to severe vasomotor symptoms associated with menopause in women with an intact uterus.

            Lead Product(s): Estradiol,Progesterone

            Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Bijuva

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: TherapeuticsMD

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 21, 2020

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