Heavy menstrual bleeding

Pathway to Cures Announces Inaugural Fund Update

Retrieved on: 
Thursday, November 2, 2023
General Health, Fund Raising, Health, Foundation, Philanthropy, Knowledge, Von Willebrand disease, Organizational founder, VWD, Hope, Biotechnology, MD, Doctor of Philosophy, MBA, Research, Hemostasis, Tan, Science, Blood, Heavy menstrual bleeding, Woman, Investment, Desmopressin, Litre, Parent, Pharmaceutical industry, Management, Pathway

Pathway to Cures (P2C) held its inaugural fund meeting on Saturday, October 28th in Chicago, Illinois.

Key Points: 
  • Pathway to Cures (P2C) held its inaugural fund meeting on Saturday, October 28th in Chicago, Illinois.
  • Pathway to Cures, an affiliate of the National Bleeding Disorders Foundation (NBDF), is a venture philanthropy fund focused on investing in early-stage companies developing cures, therapies, or enabling technologies in support of the inheritable blood and bleeding disorders community.
  • “Transcutaneous auricular neurostimulation (tAN) is a non-invasive method demonstrating great promise for treating various diseases.
  • “We have reviewed 114 companies over the past few months, whose promising research will accelerate the treatments and cures for rare diseases in the years to come.

Adial Provides Business Update Following Favorable Comments from US and EU Regulatory Meetings

Retrieved on: 
Tuesday, July 11, 2023
Partnership, Probability, Adial, Virginia, Heavy menstrual bleeding, NDA, ECG, ICH, Research, QT, AUD, Patient, Physician, Risk, MA, FDA, Safety, Pharmaceutical industry, Dietary supplement, EU

Reviewed the safety data from the ONWARD trial and did not express any concerns with the data.

Key Points: 
  • Reviewed the safety data from the ONWARD trial and did not express any concerns with the data.
  • Confirmation of the importance of identifying a patient subgroup where a relevant treatment effect and compelling evidence of a favorable risk-benefit profile can be assessed.
  • The new clinical development plan includes both the US and EU endpoints and will be designed to satisfy both US and EU AD04 submission requirements.
  • Confirmation of the clinical development plan and pathway is currently being conducted by Adial’s clinical development and regulatory advisors.

Myovant Sciences and Pfizer Receive FDA Approval for MYFEMBREE®, the First Once-Daily Treatment for Heavy Menstrual Bleeding Associated With Uterine Fibroids

Retrieved on: 
Wednesday, May 26, 2021
Drugs, Benign neoplasms, Neoplasms, Clinical medicine, Uterine fibroid, Leiomyoma, Heavy menstrual bleeding, Pfizer, Medroxyprogesterone acetate

The approval of MYFEMBREE represents the second FDA product approval for Myovant in less than one year.

Key Points: 
  • The approval of MYFEMBREE represents the second FDA product approval for Myovant in less than one year.
  • MYFEMBREEs approval is a testament to the shared commitment between Myovant and Pfizer to support women living with uterine fibroids, said Nick Lagunowich, Global President, Internal Medicine at Pfizer.
  • Myovant and Pfizer are committed to supporting women in the U.S. who are prescribed MYFEMBREE throughout their treatment journeys.
  • MYFEMBREE is indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women.

ObsEva Announces Final Results from the Phase 3 PRIMROSE Program of Yselty® (linzagolix) for the Treatment of Uterine Fibroids

Retrieved on: 
Thursday, May 20, 2021
Organ systems, Endocrine system, Hormones, GnRH antagonists, Ethers, Triketones, Antiandrogens, Antiestrogens, Uterine fibroid, Gonadotropin-releasing hormone antagonist, Heavy menstrual bleeding, Linzagolix

These results mark the final data measuring point for both the Phase 3 PRIMROSE 1 (US only) and PRIMROSE 2 (Europe and US) studies.\nThe PRIMROSE 1 and PRIMROSE 2 trials evaluated 100 mg and 200 mg doses with and without ABT.

Key Points: 
  • These results mark the final data measuring point for both the Phase 3 PRIMROSE 1 (US only) and PRIMROSE 2 (Europe and US) studies.\nThe PRIMROSE 1 and PRIMROSE 2 trials evaluated 100 mg and 200 mg doses with and without ABT.
  • Improvements in other clinically relevant secondary endpoints, including hemoglobin levels and quality of life also persisted off-treatment, supporting the durability of the treatment effect of Yselty.
  • \xe2\x80\x9cThis milestone represents the next critical step in bringing Yselty forward as a well-differentiated, once daily oral GnRH antagonist with unique dosing options designed to treat more women with uterine fibroids.
  • Linzagolix is currently in late-stage clinical development for the treatment of heavy menstrual bleeding associated with uterine fibroids and pain associated with endometriosis.

Gynesonics Announces Publication of Clinical Study Analysis Demonstrating Effectiveness of the Sonata System in Treating Submucous and Large Symptomatic Uterine Fibroids

Retrieved on: 
Thursday, April 8, 2021
Health, Medical devices, Consumer, Women, Surgery, General Health, Clinical trials, Clinical medicine, Medicine, Neoplasms, Gynaecological neoplasia, Uterine fibroid, Gynecological surgery, Uterine myomectomy, Surgical oncology, Interventional radiology, Heavy menstrual bleeding, Sonata System, Gynesonics

Among 197 women (with 534 treated fibroids), 86% of patients with only submucous fibroids and 81% of women with large fibroids (>5 cm) experienced bleeding reduction within 3 months post-ablation.

Key Points: 
  • Among 197 women (with 534 treated fibroids), 86% of patients with only submucous fibroids and 81% of women with large fibroids (>5 cm) experienced bleeding reduction within 3 months post-ablation.
  • Additional fibroid mapping of large fibroids with magnetic resonance imaging in the FAST-EU trial showed an average volume reduction of 68%.
  • Transcervical fibroid ablation with the Sonata system for treatment of submucous and large uterine fibroids.
  • Gynesonics has developed the Sonata System for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids.

Myovant Sciences and Pfizer Announce Positive Data from Phase 3 LIBERTY Randomized Withdrawal Study of Once-Daily Relugolix Combination Therapy in Women with Uterine Fibroids

Retrieved on: 
Wednesday, March 24, 2021
Chemical compounds, Organic compounds, GnRH antagonists, Chemistry, Ethers, Triketones, Gynaecological neoplasia, Uterine fibroid, Relugolix, Heavy menstrual bleeding, Placebo-controlled study

Data from the LIBERTY randomized withdrawal study demonstrate the potential value of continued treatment for women with uterine fibroids, with those receiving relugolix combination therapy in the study experiencing meaningful symptom relief for up to two years.

Key Points: 
  • Data from the LIBERTY randomized withdrawal study demonstrate the potential value of continued treatment for women with uterine fibroids, with those receiving relugolix combination therapy in the study experiencing meaningful symptom relief for up to two years.
  • The LIBERTY randomized withdrawal study (N = 229) was a Phase 3 double-blind, placebo-controlled study that enrolled eligible women who completed the LIBERTY long-term extension study.
  • Women on placebo with relapse of heavy menstrual bleeding during the study were offered re-treatment with open-label relugolix combination therapy.
  • We believe that these study results offer encouraging data in support of longer-term efficacy in women suffering from uterine fibroids.

HealthyWomen and Myovant Sciences Launch “Voices of Periods” to Fight Menstrual Stigma

Retrieved on: 
Tuesday, February 16, 2021
Branches of biology, Drugs, Midwifery, Women's health, Health, Menstruation, Fertility medicine, Amenorrhea, Uterine fibroid, Heavy menstrual bleeding, Infertility, Menstrual cycle

Im so grateful to these remarkable women for stepping up to fight the stigma around menstruation, one personal narrative at a time, said Beth Battaglino, RN-C, Chief Executive Officer of HealthyWomen.

Key Points: 
  • Im so grateful to these remarkable women for stepping up to fight the stigma around menstruation, one personal narrative at a time, said Beth Battaglino, RN-C, Chief Executive Officer of HealthyWomen.
  • While we as a society have taken steps to open up the conversation around periods, menstruation remains insufficiently discussed.
  • The videos cover common experiences of menstruation curiosity, shock, shame as well as medical conditions ranging from infertility to uterine fibroids to athletic amenorrhea.
  • Both HealthyWomen and Myovant are members of Female Forward Together, a coalition that combines expertise in healthcare, research, data science, digital health, and advocacy.

ObsEva Provides Update on Yselty® (Linzagolix) Clinical Development Program

Retrieved on: 
Monday, January 11, 2021
Gynaecology, Menstrual cycle, Neoplasms, Gynaecological neoplasia, Uterine fibroid, Human reproduction, Endometriosis, Heavy menstrual bleeding, Preterm birth, Neurocrine Biosciences, Elagolix

This marks a major milestone in making Yselty available in the E.U., and we look forward to working closely with the EMA as we advance Yselty towards commercialization.

Key Points: 
  • This marks a major milestone in making Yselty available in the E.U., and we look forward to working closely with the EMA as we advance Yselty towards commercialization.
  • The clinical development program for the endometriosis indication is a key priority for ObsEva.
  • Yselty is currently in late-stage clinical development for the treatment of heavy menstrual bleeding associated with uterine fibroids and pain associated with endometriosis.
  • Through strategic in-licensing and disciplined drug development, ObsEva has established a late-stage clinical pipeline with development programs focused on treating endometriosis, uterine fibroids and preterm labor.

Lycovary™ Daily provides anti-ageing oxygenation of the ovaries to help women with PMS, painful periods and comfortable menopause transition

Retrieved on: 
Thursday, December 24, 2020
Branches of biology, Health, Anatomy, Women's health, Midwifery, Menopause, Endocrinology, Menstrual cycle, Dysmenorrhea, Premenstrual syndrome, Heavy menstrual bleeding, Ovary

It provides clinically validated and personalised daily support for women from the beginning of their fertile phase through to the menopause.

Key Points: 
  • It provides clinically validated and personalised daily support for women from the beginning of their fertile phase through to the menopause.
  • Hundreds of millions of women around the world encounter problems before and during their periods due to ovarian hormonal imbalances.
  • In addition, hot flushes and night sweats during the menopause, early onset of osteoporosis and other health issues in later life also stem from this imbalance.
  • About 30-40% of women of reproductive age have premenstrual syndrome (PMS), and about 50% dysmenorrhea, of whom 15-20% have severe painful periods.

Lycovary™ Daily provides anti-ageing oxygenation of the ovaries to help women with PMS, painful periods and comfortable menopause transition

Retrieved on: 
Wednesday, December 23, 2020
Anatomy, Women's health, Branches of biology, Human development, Midwifery, Menstrual cycle, Premenstrual syndrome, Dysmenorrhea, Heavy menstrual bleeding, Menopause, Ovary, Menstrual disorder

It provides clinically validated and personalised daily support for women from the beginning of their fertile phase through to the menopause.

Key Points: 
  • It provides clinically validated and personalised daily support for women from the beginning of their fertile phase through to the menopause.
  • Hundreds of millions of women around the world encounter problems before and during their periods due to ovarian hormonal imbalances.
  • About 30-40% of women of reproductive age have premenstrual syndrome (PMS), and about 50% dysmenorrhea, of whom 15-20% have severe painful periods.
  • "We are pleased to announce that CaDi is launching Lycovary Daily to help women to support their health and improve the quality of their lives.