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Lead Product(s): Conjugated Estrogens
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Cenestin
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Avion Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership November 12, 2020
Details:
Avion Pharmaceuticals gets exclusive rights to relaunch Cenestin® in the USA. Cenestin® is the only plant-derived mixture of nine conjugated estrogens indicated for treatment of moderate to severe symptoms of vasomotor, and vulvar and vaginal atrophy due to menopause.
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Lead Product(s): Norelgestromin,Ethinyl Estradiol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Zafemy
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 February 26, 2021
Details:
Amneal Pharmaceuticals has received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for 150 mcg/day Norelgestromin and 35 mcg/day Ethinyl Estradiol Transdermal System.
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Lead Product(s): Estradiol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Imvexxy
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Cantor
Deal Size: $110.0 million Upfront Cash: Undisclosed
Deal Type: Public Offering February 11, 2021
Details:
TherapeuticsMD intends to use the net proceeds from the offering for commercialization of its three FDA-approved products, IMVEXXY® (estradiol vaginal inserts) for the treatment of moderate-to-severe dyspareunia (vaginal pain associated with sexual activity).
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Lead Product(s): Acetylsalicylic Acid
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Undisclosed
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 January 25, 2021
Details:
Contrary to previous findings, low-dose aspirin therapy before conception and during early pregnancy may increase pregnancy chances and live births among women who have experienced one or two prior miscarriages.
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Lead Product(s): Hydroxyprogesterone Caproate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Makena
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 14, 2020
Details:
FDA’s Notice of Opportunity for a Hearing regarding the Agency’s proposal to withdraw approval for Makena also referred to as 17-OHPC, to reduce preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.
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Lead Product(s): Norelgestromin,Ethinyl Estradiol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Evra
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Gedeon Richter Plc.
Deal Size: $263.5 million Upfront Cash: Undisclosed
Deal Type: Acquisition December 03, 2020
Details:
Evra is a transdermal contraceptive patch assets. The deal is complemented by a transitional business license agreement and series of other related agreements to run the business without interruption during the period required to transfer marketing authorizations to Richter.
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Lead Product(s): Tranexamic Acid
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Lysteda
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Amring Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition December 02, 2020
Details:
Acquisition of the global rights to LYSTEDA® (tranexamic acid), a first-in-class, non-hormonal therapy indicated specifically for treatment of women with cyclic heavy menstrual bleeding (HMB), will further strengthen Amring's position in the marketplace.
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Lead Product(s): Segesterone Acetate,Ethinyl Estradiol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Annovera
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