VVA

Daré Bioscience Reports Full Year 2023 Financial Results and Provides Company Update

Retrieved on: 
Thursday, March 28, 2024
Cream, Dysmenorrhea, Patient, History, Bacteria, G&A, Vaginal discharge, IND, Bayer, Human development, Investment, Diclofenac, NSAID, Menstruation, Research, Hormone, Bacterial vaginosis, P-value, Webcast, SAN, NIH, Trial of the century, Pleasure, Woman, Breast cancer, Safety, Pharmacokinetics, Food, Development, Menopause, Nonsteroidal anti-inflammatory drug, HR, ARPA, VVA, Tamoxifen, FDA, Attention, CRADA, Female, Dyspareunia, Ecosystem, NICHD, Bangladesh Technical Education Board

SAN DIEGO, March 28, 2024 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today reported financial results for the year ended December 31, 2023 and provided a company update.

Key Points: 
  • In addition, we are excited about the increased attention that women’s health has received more broadly,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience.
  • In December 2023, Daré announced positive topline results from the Phase 1 study evaluating the pharmacokinetics (PK), safety, and exploratory efficacy of DARE-PDM1.
  • Financial Highlights for the Year Ended December 31, 2023 and 2024 Projections
    Cash and cash equivalents: $10.5 million at December 31, 2023.
  • Daré will host a conference call and live webcast today, March 28, 2024, at 4:30 p.m. Eastern Time to review financial results for the year ended December 31, 2023 and to provide a company update.

Knight Therapeutics Announces Product Launch for IMVEXXY® in Canada

Retrieved on: 
Thursday, January 4, 2024
Quality of life, Woman, GUD, Estradiol, Pain, Menopause, Dry, Dyspareunia, Therapy, Vaginal discharge, VVA, Ageing, Common, Health Canada, TSX, Patient, Birth control

MONTREAL, Jan. 04, 2024 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc., (TSX: GUD) ("Knight"), a pan-American (ex-USA) specialty pharmaceutical company, announced today the launch of IMVEXXY® in Canada.

Key Points: 
  • MONTREAL, Jan. 04, 2024 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc., (TSX: GUD) ("Knight"), a pan-American (ex-USA) specialty pharmaceutical company, announced today the launch of IMVEXXY® in Canada.
  • “We are very excited about the launch of IMVEXXY®, a new treatment option for postmenopausal women in Canada.
  • Knight and TherapeuticsMD signed a license agreement in July 2018 pursuant to which TherapeuticsMD granted Knight the exclusive Canadian commercialization rights to IMVEXXY® (estradiol vaginal inserts).
  • Under the terms of the license agreement related to IMVEXXY® in Canada, Knight will pay TherapeuticsMD sales milestone fees and royalties based upon certain aggregate annual sales of IMVEXXY® in Canada.

Daré Bioscience Announces FDA Clearance of Investigational New Drug (IND) Application for DARE-VVA1, a Novel Intravaginal Formulation of Tamoxifen for Moderate to Severe Dyspareunia, a Symptom of Vulvar and Vaginal Atrophy Associated with Menopause

Retrieved on: 
Thursday, December 7, 2023
Personal lubricant, Quality of life, Food, Woman, IND, Breast cancer, HR, FDA, Prevalence, Menopause, Syndrome, Dyspareunia, SAN, Inflammation, VVA, History, Tamoxifen, Pharmaceutical industry

With the IND clearance from the FDA, Daré can begin planning for an anticipated Phase 2 randomized, double-blinded, placebo-controlled, dose-finding clinical study of DARE-VVA1.

Key Points: 
  • With the IND clearance from the FDA, Daré can begin planning for an anticipated Phase 2 randomized, double-blinded, placebo-controlled, dose-finding clinical study of DARE-VVA1.
  • VVA is an inflammation and thinning of the vaginal epithelium due to chronic hypo-estrogenism, which is the reduction in levels of circulating estrogen.
  • Typical symptoms include vaginal dryness, itching, burning, and painful intercourse (dyspareunia), adversely impacting quality of life.
  • Products containing estrogen are commonly used to treat VVA but some women cannot or choose not to use these products, including those with a history of hormone-receptor positive (HR+) breast cancer.

Azure Biotech Announces Educational Initiative to Create Awareness of Unmet Women’s Menopausal Medical Issue

Retrieved on: 
Wednesday, August 30, 2023
Woman, Vaginal discharge, VVA, Pharmaceutical industry

RIVER VALE, N.J., Aug. 30, 2023 (GLOBE NEWSWIRE) -- Azure Biotech, Inc., a privately held women’s health company that is developing novel formulations of lasofoxifene for vulvovaginal atrophy (VVA), launches an educational campaign to support women with this underserved menopausal health condition affecting millions of women.

Key Points: 
  • RIVER VALE, N.J., Aug. 30, 2023 (GLOBE NEWSWIRE) -- Azure Biotech, Inc., a privately held women’s health company that is developing novel formulations of lasofoxifene for vulvovaginal atrophy (VVA), launches an educational campaign to support women with this underserved menopausal health condition affecting millions of women.

Daré Bioscience Announces Publication of Phase 1/2 Pharmacokinetic, Safety and Pharmacodynamic Data for DARE-VVA1 - a Potential New Hormone-Free Treatment for Vulvovaginal Atrophy - in Climacteric, the Journal of the International Menopause Society

Retrieved on: 
Friday, June 9, 2023
Survivor, Prevalence, Journal, Vaginal discharge, International Menopause Society, Pharmacokinetics, Woman, History, Trial of the century, Hormone, HR, Investigational New Drug, MD, Patient, Article, SAN, IND, Tamoxifen, Safety, Breast cancer, VVA, Pharmaceutical industry, Birth control, Climacteric

The journal article, “Pharmacokinetics, safety and preliminary pharmacodynamic evaluation of DARE-VVA1: a soft gelatin capsule containing tamoxifen for the treatment of vulvovaginal atrophy,” was published online and will appear in Climacteric, the official journal of the International Menopause Society.

Key Points: 
  • The journal article, “Pharmacokinetics, safety and preliminary pharmacodynamic evaluation of DARE-VVA1: a soft gelatin capsule containing tamoxifen for the treatment of vulvovaginal atrophy,” was published online and will appear in Climacteric, the official journal of the International Menopause Society.
  • The randomized, double-blind, placebo-controlled study was designed to evaluate the pharmacokinetics, safety and pharmacodynamics of DARE-VVA1 in postmenopausal participants with moderate to severe VVA.
  • “The unmet need for an effective non-hormonal treatment for VVA caused by anti-cancer endocrine therapy in patients diagnosed with HR+ breast cancer is undeniable.
  • Daré is conducting activities to support submission of an Investigational New Drug (IND) application and initiation of a Phase 2 clinical study of DARE-VVA1.

Cosette Pharmaceuticals Acquires Intrarosa® from Endoceutics, Inc.

Retrieved on: 
Thursday, June 8, 2023
Health, Consumer, Women, Other Health, General Health, Pharmaceutical, Cardiology, Dyspareunia, BSE, Partnership, Vaginal discharge, Vulvar Crohn's disease, Woman, Multimedia, Medication, Orange Book, Acquisition, Lacerum, Patent, Menopause, VVA, Pharmaceutical industry, Avia, EU

Cosette Pharmaceuticals, Inc. ("Cosette"), a US-based specialty pharmaceutical company with a focus on women’s health and cardiovascular medicines, has completed the acquisition of the global rights to Intrarosa® from Endoceutics, Inc., a subsidiary of Endorecherche, Inc.

Key Points: 
  • Cosette Pharmaceuticals, Inc. ("Cosette"), a US-based specialty pharmaceutical company with a focus on women’s health and cardiovascular medicines, has completed the acquisition of the global rights to Intrarosa® from Endoceutics, Inc., a subsidiary of Endorecherche, Inc.
  • The transaction includes 108 issued and pending patents across the globe with the latest expiring in 2033 including 3 Orange Book listed patents.
  • View the full release here: https://www.businesswire.com/news/home/20230608005297/en/
    Apurva Saraf, President and CEO of Cosette stated, “This transformative acquisition further strengthens Cosette’s commitment to women’s health with a patent protected, novel drug formulation.
  • In partnership with MSH Pharma Inc., Cosette will leverage its unique commercial and manufacturing capabilities to ensure continued patient access to Intrarosa®.

Eaton to display innovative emission-reduction technologies at Auto Shanghai

Retrieved on: 
Tuesday, April 11, 2023
Automotive, Vehicle Technology, Technology, Engineering, Sustainability, Automotive Manufacturing, Logistics, Supply Chain Management, Manufacturing, General Automotive, Environment, Trucking, Green Technology, Other Automotive, Alternative Energy, Energy, Transport, Other Technology, Performance & Special Interest, Fleet Management, EV, Electric Vehicles, Cylinder, Partnership, Eaton, Hydrogen, Auto Shanghai, Original equipment manufacturer, Quality of life, Multimedia, Temperature, Nitrogen, CDA, NOx, Sanitation, CO2, SCR, VVA, Gasoline, Heating, ventilation, and air conditioning, Renewable energy

View the full release here: https://www.businesswire.com/news/home/20230403005924/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20230403005924/en/
    Eaton’s cylinder deactivation and late intake valve closing technologies can reduce harmful emissions in diesel-powered commercial vehicles.
  • (Photo: Business Wire)
    Diesel engine emissions regulations are driving development of new engine and aftertreatment technologies.
  • “VVA technologies play an important role to enable OEMs to meet new regulations,” said Bo Yang, president, Eaton Vehicle Group and eMobility APAC.
  • CDA simultaneously reduces both NOx and CO2, making it more efficient than other technologies that reduce NOx at the expense of CO2.

Sermonix’s Lasofoxifene Improves Vaginal/Vulvar Symptoms Relative to Fulvestrant in ELAINE 1 Study of Postmenopausal Women with Locally Advanced or Metastatic ER+/HER2- Breast Cancer and an ESR1 Mutation

Retrieved on: 
Monday, March 6, 2023
Therapy, Mutation, Breast, AIS, Woman, Lasofoxifene, ESR1, Memorial Sloan Kettering Cancer Center, Dry, International Society, Menopause, Patient, ESMO, Progression-free survival, European Society for Medical Oncology, Breast cancer, Congress, VAS, Pain, Oncology, Cyclin-dependent kinase 4, VVA, Vua tiếng Việt, Fulvestrant, Vaginal discharge, Irritation, Birth control, Dietary supplement

Top-line data for ELAINE 1, which began enrollment in September 2019, were shared in September at the European Society for Medical Oncology (ESMO) Congress 2022.

Key Points: 
  • Top-line data for ELAINE 1, which began enrollment in September 2019, were shared in September at the European Society for Medical Oncology (ESMO) Congress 2022.
  • This secondary analysis aimed to investigate changes in vaginal/vulvar symptoms with lasofoxifene versus fulvestrant, as lasofoxifene improved symptoms of vulvovaginal atrophy (VVA) in two previous Phase 3 studies among postmenopausal women with moderate to severe VVA.
  • Vaginal/vulvar symptoms were evaluated in an exploratory analysis using the vaginal (VAS) and vulvar (VuAS) assessment scales, instruments validated in breast cancer patients to assess dryness, soreness, irritation, and pain.
  • “We look forward to further investigating lasofoxifene’s efficacy, as a treatment for metastatic breast cancer with fewer negative side effects that greatly impact patients’ quality of life.”

Madorra announces publication of positive 12-week and 12-month Pilot 1 Randomized Controlled Trial Results

Retrieved on: 
Thursday, February 9, 2023
Hormone, Woman, Trial of the century, PRO, Menopause, Vaginal discharge, Randomized controlled trial, Gold, VVA, North American Menopause Society, Safety, Breast cancer, GSM, Personal lubricant, Coronavirus Scientific Advisory Board, Research, PH, Reproductive Sciences, International Society, Survivor, Department of Obstetrics and Gynecology (Massachusetts General Hospital), Vagina, Dry, Irritation, UCSF, Birth control, Pharmaceutical industry, Gynaecology, Obstetrics

PORTLAND, Ore., Feb. 9, 2023 /PRNewswire/ -- Madorra announces publication of positive Pilot 1 randomized controlled trial results for the company's non-invasive, home-use device for women experiencing moderate to severe vulvovaginal atrophy (VVA), a component of genitourinary syndrome of menopause (GSM).

Key Points: 
  • The Company's Pilot 1 clinical study evaluated the safety and effectiveness of therapeutic ultrasound for treatment of vaginal dryness in postmenopausal women with VVA.
  • "We are thrilled to have achieved these exciting results in our first randomized controlled pilot trial of the Madorra device," said CEO, Holly Rockweiler.
  • In addition, the company has recently completed a second randomized controlled trial, Pilot 2.
  • Madorra was founded to change the paradigm for treating vaginal dryness by providing a nonhormonal, noninvasive solution to VVA.

Daré Bioscience Announces Positive Topline Results from DARE-VVA1 Phase 1/2 Clinical Study

Retrieved on: 
Monday, November 14, 2022
Cream, Trial of the century, Tablet, Breast cancer, Intravaginal administration, Safety, Disease, Fertility, Risk, Plasma, Prevalence, Organon, Birth, PK, Form, Aromatase, Social media, Vaginal discharge, Survivor, Personal lubricant, Progesterone, Inflammation, Intellectual property, Pain, Tamoxifen, COVID-19, Health, Vulvar cancer, FDA, Failure, SERM, Quality of life, Female, Pharmacokinetics, Bacterial vaginosis, Recurrence, Food, Woman, Oncology, 8-K, Health minister, Dyspareunia, PD, Menopause, Tissue, History, Patient, Birth control, Pharmaceutical industry, VVA, Bayer

SAN DIEGO, Nov. 14, 2022 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced topline data from its Phase 1/2 clinical study of DARE-VVA1, a novel intravaginal proprietary formulation of tamoxifen being developed for the treatment of moderate to severe vulvar and vaginal atrophy. The randomized, double-blind, placebo-controlled study was designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of DARE-VVA1 in postmenopausal participants with moderate to severe VVA. The topline data from the study demonstrated safety and tolerability of DARE-VVA1, as well as improvement in the vaginal cytology parameters and the bothersome vaginal symptoms associated with VVA. DARE-VVA1 has the potential to be the first therapeutic specifically approved for the treatment of VVA in U.S. patients with HR+ breast cancer. There are currently no FDA-approved products labeled for VVA treatment in HR+ breast cancer patients.

Key Points: 
  • We are highly encouraged by the positive topline results of the Phase 1/2 study of DARE-VVA1 as this study is a critical step in developing a potential non-hormonal treatment alternative for VVA, said Dr. Annie Thurman, Medical Director of Dar Bioscience.
  • The Phase 1/2 study evaluated different doses of DARE-VVA1, a tamoxifen vaginal insert, in 17 postmenopausal women with VVA.
  • The study was a randomized, multi-center, double-blind, parallel-arm, placebo-controlled, dose-ranging study that evaluated the safety, tolerability, plasma pharmacokinetics (PK) and pharmacodynamics (PD) of DARE-VVA1.
  • Dar plans to submit data from the Phase 1/2 clinical study of DARE-VVA1 for publication in a peer-reviewed publication.