Uterine fibroid

 Acessa Health Announces Positive Payer Coverage, with Over Half of Insured Americans Covered for the Procedure

Retrieved on: 
Tuesday, July 7, 2020

(1) More than 156 million Americans are covered for the Acessa procedure, with expanded coverage over the last 12 months in Maryland, Massachusetts, North Carolina, North Dakota, Ohio, Pennsylvania, and Washington DC.

Key Points: 
  • (1) More than 156 million Americans are covered for the Acessa procedure, with expanded coverage over the last 12 months in Maryland, Massachusetts, North Carolina, North Dakota, Ohio, Pennsylvania, and Washington DC.
  • The Acessa procedure is designed to treat women with uterine fibroids and is clinically proven with long-term data as a safe alternative to hysterectomy and myomectomy.
  • (2)
    Acessa Health is a womens health innovator dedicated to advancing minimally invasive, uterine-sparing solutions for women with symptomatic fibroids.
  • Although many patients may benefit from the Acessa Procedure, this treatment is not for everyone and results may vary.

Myovant Sciences Presents Additional Data on Relugolix Combination Therapy from Phase 3 LIBERTY Studies in Women with Uterine Fibroids and from Ovulation Inhibition Study

Retrieved on: 
Monday, July 6, 2020

Furthermore, the data from our ovulation inhibition study showed inhibition in 100% of women on treatment as well as rapid return after stopping treatment, potentially offering women the ability to control their ovulation and fertility goals.

Key Points: 
  • Furthermore, the data from our ovulation inhibition study showed inhibition in 100% of women on treatment as well as rapid return after stopping treatment, potentially offering women the ability to control their ovulation and fertility goals.
  • Relugolix combination therapy improves hemoglobin levels in anemic women with heavy menstrual bleeding due to uterine fibroids: results from the LIBERTY Phase 3 program (oral presentation, O-023)
    In the Phase 3 LIBERTY program, approximately one-third of women had anemia (hemoglobin 10.5 g/dL) at baseline.
  • Once-daily dosing with relugolix combination therapy resulted in suppression of ovarian activity and inhibition of ovulation in 100% of women during the treatment period.
  • Myovant also recently reported positive data from its second Phase 3 SPIRIT trial evaluating relugolix combination therapy in women with endometriosis.

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

Retrieved on: 
Monday, July 6, 2020

In addition, new data from PRIMROSE 2 demonstrate that continued treatment with linzagolix for 52 weeks provides sustained efficacy and is well tolerated.

Key Points: 
  • In addition, new data from PRIMROSE 2 demonstrate that continued treatment with linzagolix for 52 weeks provides sustained efficacy and is well tolerated.
  • We are extremely pleased by the overall performance of Yselty in addressing heavy menstrual bleeding, a major symptom of uterine fibroids.
  • These excellent data move us closer to the potential commercialization of Yselty and our immediate priority is to progress our regulatory filings.
  • These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements.

ObsEva SA to present at ESHRE Virtual 36th Annual Meeting, July 5-8, 2020

Retrieved on: 
Friday, July 3, 2020

Geneva, Switzerland and Boston, MA July 3, 2020 ObsEva SA (NASDAQ: OBSV), a clinical-stage biopharmaceutical company developing and commercializing novel therapies to improve womens reproductive health, today announced that they will present at ESHRE Virtual 36th Annual Meeting, taking place July 5-8, 2020.

Key Points: 
  • Geneva, Switzerland and Boston, MA July 3, 2020 ObsEva SA (NASDAQ: OBSV), a clinical-stage biopharmaceutical company developing and commercializing novel therapies to improve womens reproductive health, today announced that they will present at ESHRE Virtual 36th Annual Meeting, taking place July 5-8, 2020.
  • 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, preterm labor, and improving ET outcomes following IVF.
  • ObsEva is listed on the Nasdaq Global Select Market and is trading under the ticker symbol "OBSV" and on the SIX Swiss Exchange where it is trading under the ticker symbol OBSN.
  • For more information, please visit www.ObsEva.com .

Gynesonics Announces Publication of CHOICES: A Comparative Study of the Sonata Treatment VERSUS Myomectomy

Retrieved on: 
Tuesday, June 30, 2020

The study compared the short-term resource utilization, facility costs, and perioperative patient outcomes for transcervical fibroid ablation (TFA) using the Sonata system compared to myomectomy.

Key Points: 
  • The study compared the short-term resource utilization, facility costs, and perioperative patient outcomes for transcervical fibroid ablation (TFA) using the Sonata system compared to myomectomy.
  • All procedure, anesthesia, laboratory, pathology, and pharmacy costs were significantly higher for myomectomy as compared to TFA with Sonata.
  • TFA was also associated with significantly lower facility procedure-related costs compared to myomectomy, including inpatient, abdominal, or laparoscopic myomectomy.
  • CHOICES, an essential head-to-head comparator study, now demonstrates the procedural cost and early patient outcome advantages provided by Sonata over myomectomy.

Myovant Sciences to Host Webcast and Conference Call at 8:30 am Eastern Time Tuesday, June 23 to Discuss Results from Phase 3 SPIRIT 1 Study Evaluating Once-Daily Relugolix Combination Therapy in Women with Endometriosis

Retrieved on: 
Monday, June 22, 2020

The webcast and conference call to discuss the data will be held on Tuesday, June 23, 2020 at 8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time.

Key Points: 
  • The webcast and conference call to discuss the data will be held on Tuesday, June 23, 2020 at 8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time.
  • Myovant Sciencesaspires to be the leading healthcare company focused on redefining care for women and for men.
  • The companys lead product candidate is relugolix, a once-daily, oral GnRH receptor antagonist.
  • The companyhas three late-stage clinical programs for relugolix in uterine fibroids, endometriosis, and prostate cancer.

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

Retrieved on: 
Monday, June 1, 2020

Food and Drug Administration(FDA) for its once-daily relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for the treatment of women with heavy menstrual bleeding associated with uterine fibroids.

Key Points: 
  • Food and Drug Administration(FDA) for its once-daily relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for the treatment of women with heavy menstrual bleeding associated with uterine fibroids.
  • The NDA is the third regulatory application Myovant has submitted this year, following a Marketing Authorization Application to the European Medicines Agency in uterine fibroids and an NDA in advanced prostate cancer.
  • In addition, relugolix combination therapy was generally well-tolerated including minimal bone mineral density loss over 24 weeks.
  • Bone mineral density was comparable between the relugolix combination therapy and placebo groups in LIBERTY 1 and 2.

FDA Approves the First Oral Medication for the Management of Heavy Menstrual Bleeding Due to Uterine Fibroids in Pre-menopausal Women

Retrieved on: 
Friday, May 29, 2020

"This approval provides women with a non-surgical option to help address unresolved heavy menstrual bleeding in an impactful way."

Key Points: 
  • "This approval provides women with a non-surgical option to help address unresolved heavy menstrual bleeding in an impactful way."
  • "ORIAHNN signifies an important advance in how we can care for women with uterine fibroids."
  • "The FDA's approval of an oral treatment for women suffering from heavy menstrual bleeding due to uterine fibroids marks a step forward in women's health.
  • ORIAHNN can decrease your menstrual bleeding or result in no menstrual bleeding at all, making it hard to know if you are pregnant.

FDA Approves New Option to Treat Heavy Menstrual Bleeding Associated with Fibroids in Women

Retrieved on: 
Friday, May 29, 2020

Various non-surgical therapies are used to treat fibroid-related heavy menstrual bleeding, but none have been FDA-approved specifically for this use.

Key Points: 
  • Various non-surgical therapies are used to treat fibroid-related heavy menstrual bleeding, but none have been FDA-approved specifically for this use.
  • Fibroids are benign (non-cancerous) muscle tumors of the uterus that can cause heavy menstrual bleeding, pain, bowel or bladder problems and infertility.
  • Some women may not experience any symptoms, but many do, including heavy bleeding with periods.
  • Heavy menstrual bleeding at baseline was defined as having at least two menstrual cycles with greater than 80 mL (about a third of a cup) of menstrual blood loss (MBL).

ObsEva SA to present at the Jefferies Virtual Healthcare Conference June 3rd, 2020

Retrieved on: 
Friday, May 29, 2020

Geneva, Switzerland and Boston, MA May 29, 2020 ObsEva SA (NASDAQ: OBSV), a clinical-stage biopharmaceutical company developing and commercializing novel therapies to improve womens reproductive health, today announced that CEO Ernest Loumaye will present an update on the Company and its pipeline at the Jefferies Virtual Healthcare Conference taking place June 2-4, 2020.

Key Points: 
  • Geneva, Switzerland and Boston, MA May 29, 2020 ObsEva SA (NASDAQ: OBSV), a clinical-stage biopharmaceutical company developing and commercializing novel therapies to improve womens reproductive health, today announced that CEO Ernest Loumaye will present an update on the Company and its pipeline at the Jefferies Virtual Healthcare Conference taking place June 2-4, 2020.
  • Mr. Loumayes presentation will take place on Wednesday June 3, 2020 at 8:00 a.m. Eastern Time (ET).
  • 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, preterm labor, and improving ET outcomes following IVF.
  • ObsEva is listed on the Nasdaq Global Select Market and is trading under the ticker symbol "OBSV" and on the SIX Swiss Exchange where it is trading under the ticker symbol OBSN.