Bacterial vaginosis

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.

North America Molecular Diagnostics Market Size, Share & Trends Analysis Report 2024-2030: Growing Prevalence of Target Diseases & Increasing External Funding for R&D Fueling Expansion - ResearchAndMarkets.com

Retrieved on: 
Tuesday, March 26, 2024
Health, Biotechnology, Candidiasis, Diagnosis, PCR, MVP, Conditional sentence, Bacterial vaginosis, Prevalence, Infection, Promega, Country, Thermo Fisher Scientific, SME, Tuberculosis, Application, ISH, RT, HIV, Alzheimer's disease, Incidence, Turner syndrome, Cepheid variable, Research, Trichomoniasis, Real-time, Cancer, Death, Parkinson's disease, CDC, QIAGEN, Therapy, USD, Horvitz–Thompson estimator, Helix, DSM-IV codes, Vaccine

Advancements in molecular diagnostic technology enabled the early detection of numerous diseases and reduced the possibility of severe economic & social burdens.

Key Points: 
  • Advancements in molecular diagnostic technology enabled the early detection of numerous diseases and reduced the possibility of severe economic & social burdens.
  • Molecular diagnostics enable early diagnosis of cancer, genetic disorders, and infectious diseases by using PCR, sequencing, & genetic technologies.
  • In addition, the increasing incidence of diseases, such as influenza A & B, is projected to drive market growth.
  • An increase in external funding to conduct clinical studies in molecular diagnostics is anticipated to fuel the market.

Thomas M. Krummel, MD Joins Silicon Valley Innovations, Inc. Board of Directors

Retrieved on: 
Wednesday, March 13, 2024
Vagina, Bacterial vaginosis, SVI, Amazon, Plague, Patient, Pharmacy, American Academy, Stanford University, Silicon, American College, Fungal infection, Woman, OTC, Asthma, Nose, HRG, AAAAI, Medicine

SILICON VALLEY, Calif., March 13, 2024 /PRNewswire/ -- Silicon Valley Innovations (SVI) announced today that Thomas M. Krummel, MD, an internationally acclaimed surgeon, former Chair of the Department of Surgery at Stanford University, and med-tech innovator, has joined the company's Board of Directors.

Key Points: 
  • SILICON VALLEY, Calif., March 13, 2024 /PRNewswire/ -- Silicon Valley Innovations (SVI) announced today that Thomas M. Krummel, MD, an internationally acclaimed surgeon, former Chair of the Department of Surgery at Stanford University, and med-tech innovator, has joined the company's Board of Directors.
  • "We're very fortunate to have Dr. Krummel joining us at SVI," says CEO and Founder of SVI, Gail Lebovic, MD.
  • "We share a vision for the future of medicine that includes creating clinically relevant medical technology and placing it into the hands of patients."
  • Dr. Krummel sees major potential clinical benefits and market opportunities for SVI's offerings.

Biom Pharmaceutical Published Clinical Safety & Efficacy of VagiBiom® Microbiome-based Probiotic Suppositories for Intimate Women's Health

Retrieved on: 
Tuesday, February 27, 2024
Urinary tract infection, Woman, Paraben, Vaginitis, BV, VHI, Research, Bacterial vaginosis, Smoking, Quality control, Health, Safety, Swimming, Scientific Reports, Patient, Trial of the century, Peri, Lactobacillus delbrueckii, Birth control

Numerous studies suggest that a balanced vaginal microbiome is critical to long-term health and wellness.

Key Points: 
  • Numerous studies suggest that a balanced vaginal microbiome is critical to long-term health and wellness.
  • "We are excited to share the results of the VagiBIOM clinical study; the need for natural solutions in vaginal health is largely unmet.
  • The results of the current peer-reviewed published clinical trial reinforce the safety and efficacy of our product.
  • However, the current peer-reviewed clinical results further reinforce the safety and efficacy of our product,” said Biom's Founder & President, Dr. Bobban Subhadra.

Medicines360 and DKT WomanCare Announce Strategic Partnership to Expand Access to the Hormonal IUD Avibela™

Retrieved on: 
Wednesday, January 31, 2024
SAN, Nausea, Clinical trial, Perforation, Birth, Fibroid, Internal bleeding, Liver failure, Infection, Artery, Pelvic pain, DKT International, Jaundice, Anticoagulant, Blood pressure, Ovarian cyst, Woman, Acne, Organization, Partnership, Endometritis, Angioedema, History, Abscess, Contraindication, DKT, Peritonitis, Rash, Coagulopathy, Dyspareunia, Inflammatory cytokine, Adhesion, Vomiting, Bacterial vaginosis, Headache, Bowel obstruction, IUS, Uterus, STI, Breast cancer, Miscarriage, Patient, Fertility, Sepsis, Marketing, Risk, Stroke, Organ, Streptococcus, Hormone-sensitive cancer, Liver tumor, Cyst, Intrauterine device, GAS, Pregnancy, PID, Social marketing, Vaginitis, Migraine, Myocardial infarction, Health, Brain, Birth control

"As a global nonprofit pharmaceutical organization dedicated to expanding access to affordable reproductive health products for women, DKT WomanCare is an ideal partner for our organization," said Dr. Andrea Olariu, CEO of Medicines360.

Key Points: 
  • "As a global nonprofit pharmaceutical organization dedicated to expanding access to affordable reproductive health products for women, DKT WomanCare is an ideal partner for our organization," said Dr. Andrea Olariu, CEO of Medicines360.
  • “DKT WomanCare looks forward to leveraging our global partnerships and commercial relationships to ensure every woman, regardless of income, can access affordable, high-quality contraception.
  • As the supplier of AVIBELA, Medicines360 will focus on providing quality assurance and regulatory oversight, as well as ensuring sustainable product supply to DKT WomanCare and global procurement agencies.
  • Together, Medicines360 and DKT WomanCare will meet the growing demand for quality-assured, affordable hormonal IUDs and help build a robust and sustainable global contraceptive market.

Cepheid Receives Expanded FDA Clearance with CLIA Waiver for Xpert® Xpress MVP

Retrieved on: 
Thursday, January 18, 2024
Cepheid variable, MVP, Woman, Yeast, Patient, Vaginitis, Infection, Trichomonas, CLIA, Diagnosis, Bacterial vaginosis, Risk, Recurrence, BV, Medical error, VVC, Candidiasis, PCR, EVP, Physician, Pharmaceutical industry

SUNNYVALE, Calif., Jan. 18, 2024 /PRNewswire/ -- Cepheid announced today that it has received FDA Clearance with Clinical Laboratory Improvement Amendments (CLIA) waiver for Xpert® Xpress MVP. This multiplex vaginal panel can now be performed in near-patient settings, enabling results within 60 minutes from a single specimen for Bacterial Vaginosis (BV), Vulvovaginal Candidiasis (VVC), and Trichomoniasis (TV). This expanded claim exemplifies Cepheid's commitment to providing expanded access to women's and sexual health by making PCR testing accessible at the point of care. The test runs on Cepheid's GeneXpert Xpress instruments and has been approved for testing women fourteen years of age and older.

Key Points: 
  • SUNNYVALE, Calif., Jan. 18, 2024 /PRNewswire/ -- Cepheid announced today that it has received FDA Clearance with Clinical Laboratory Improvement Amendments (CLIA) waiver for Xpert® Xpress MVP.
  • This expanded claim exemplifies Cepheid's commitment to providing expanded access to women's and sexual health by making PCR testing accessible at the point of care.
  • The test runs on Cepheid's GeneXpert Xpress instruments and has been approved for testing women fourteen years of age and older.
  • For more information about Cepheid's Xpert Xpress MVP test, please visit Cepheid's website.

Organon’s XACIATO™ (clindamycin phosphate) Vaginal Gel 2% Available Nationwide to Treat Bacterial Vaginosis (BV) in Females Aged 12 and Older

Retrieved on: 
Wednesday, January 10, 2024
Health, Consumer, Women, General Health, Pharmaceutical, Biotechnology, CDAD, Development, Woman, Hydrogen chloride, Hypersensitivity, Patient, OGN, Frustration, Thermoregulation, Gynaecology, History, Bacterial vaginosis, Clostridioides, Environment, Recurrence, Research and development, BV, Bacteria, Clindamycin, Lincomycin, Infection, American College

Organon (NYSE: OGN), a global healthcare company with a focus on women’s health, announced that XACIATO™ (clindamycin phosphate) vaginal gel 2% is available by prescription to treat bacterial vaginosis (BV).

Key Points: 
  • Organon (NYSE: OGN), a global healthcare company with a focus on women’s health, announced that XACIATO™ (clindamycin phosphate) vaginal gel 2% is available by prescription to treat bacterial vaginosis (BV).
  • Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents.
  • If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued.
  • Information about XACIATO, and the eVoucher instant savings coupon for eligible patients, can be found at XACIATO.com .

Suzhou OSAI Biopharma Announces Positive Phase III Clinical Trial Results for Lactobacillus Crispatus Live Bacteria Capsule, Significantly Reducing Recurrence of Gynecological Infections

Retrieved on: 
Tuesday, December 12, 2023
Research, Infectious Diseases, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Science, Safety, Piper LBP, Incidence, Vaginitis, Gynaecology, Patient, Infection, Bacterial vaginosis, Medicine in China, MD, Phase, LBP, Obstetrics, Recurrence, BV, Therapure BioPharma Inc, Pharmaceutical industry

Suzhou OSAI Biopharma, Inc., a biopharmaceutical company focused on developing live biotherapeutic products (LBPs), today announced that its Phase III clinical trial of vaginal L. crispatus live bacteria capsule (Lc262-1) has successfully met its primary and secondary endpoints.

Key Points: 
  • Suzhou OSAI Biopharma, Inc., a biopharmaceutical company focused on developing live biotherapeutic products (LBPs), today announced that its Phase III clinical trial of vaginal L. crispatus live bacteria capsule (Lc262-1) has successfully met its primary and secondary endpoints.
  • The Phase III study was a multicenter, randomized, double-blind, placebo-controlled trial that enrolled 320 patients with bacterial vaginosis (BV).
  • After receiving seven days of oral metronidazole and vaginal LBP/placebo combination therapy, the cured patients were followed up for three months.
  • “This Phase III clinical trial is the first registrational Phase III clinical trial globally to evaluate the efficacy of L. crispatus in reducing BV recurrence under a rigorous clinical design.

Daré Bioscience Reports Third Quarter 2023 Financial Results and Provides Company Update

Retrieved on: 
Thursday, November 9, 2023
Cream, Female, FDA, Bacterial vaginosis, Research, Human development, Trial of the century, Cooperative research and development agreement, Vaginal discharge, Food, Hot, Organon, Human services, Eunice Kennedy Shriver National Institute of Child Health and Human Development, G&A, Progesterone, Phase 3, Quarter, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Call, Development, NICHD, Webcast, Clinical trial, ID, Tamoxifen, FSAD, Bacteria, Hormone, NIH, Woman, Safety, Office of Inspector General, U.S. Department of Health and Human Services, Use of Free and Open-Source Software (FOSS) in the U.S. Department of Defense, Patient, Bangladesh Technical Education Board, Pharmaceutical industry, Birth control, Bayer, Conference

SAN DIEGO, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today reported financial results for the quarter ended September 30, 2023 and provided a company update.

Key Points: 
  • ET
    SAN DIEGO, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today reported financial results for the quarter ended September 30, 2023 and provided a company update.
  • XACIATO™ provides a new therapeutic option for the millions of women suffering from bacterial vaginosis in the U.S.
  • Financial Highlights for the Quarter ended September 30, 2023
    Cash and cash equivalents: $13.8 million at September 30, 2023.
  • Daré will host a conference call and live webcast today, November 9, 2023, at 4:30 p.m. Eastern Time to review financial results for the quarter ended September 30, 2023 and to provide a company update.

PHASE Scientific Americas Announces INDICAID Health™ At-Home Test Kits and Digital Health Platform

Retrieved on: 
Wednesday, October 25, 2023
Seniors, General Health, Health, Medical Devices, Convenience Store, Online Retail, Consumer, Retail, Science, Korea Disease Control and Prevention Agency, Chlamydia, CDC, STI, Gonorrhea, Vaginitis, COVID-19, Bacterial vaginosis, Pharmacy, Patient, Empathy, BV, Infection, Medical device, Trichomoniasis, COVID, Candidiasis

PHASE Scientific Americas (PHASE Scientific), a fast-growing, global biomedical company developing innovative solutions to revolutionize healthcare diagnostics, announces INDICAID health™, its new line of at-home health tests and digital health experiences.

Key Points: 
  • PHASE Scientific Americas (PHASE Scientific), a fast-growing, global biomedical company developing innovative solutions to revolutionize healthcare diagnostics, announces INDICAID health™, its new line of at-home health tests and digital health experiences.
  • INDICAID health™ was created to help patients get back to better health faster and with less hassle.
  • “INDICAID health™ supports PHASE Scientific’s mission of shaping the future of at-home, personal diagnostics with people-first, science-based innovations,” said Felix Chao, General Manager of PHASE Scientific Americas.
  • The INDICAID health™ Sexual Health 2 test checks for the top two common STIs: Chlamydia and Gonorrhea.