NICHD

Digital Infuzion Welcomes Dr. Davyd Chung as Chief Growth Officer to Spearhead Strategic Expansion

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Lunedì, Maggio 6, 2024
Public, University, Executive, Bangladesh Technical Education Board, HHS, DHA, NIH, UIC, Biomedical Research, DLH, NICHD, Growth, Doctor of Philosophy, National Cancer Institute, Molecular biology, Defense Health Agency, NCI, Champaign–Urbana metropolitan area, Human development, Defense, Nursing

ROCKVILLE, Md., May 6, 2024 /PRNewswire-PRWeb/ -- Joining the team on April 8, Dr. Davyd Chung brings over two decades of distinguished expertise in strategic growth and business development within the health sector.

Key Points: 
  • Digital Infuzion, a leader in health information technology solutions, is thrilled to announce the appointment of Dr. Davyd Chung as its new Chief Growth Officer.
  • Digital Infuzion is confident that Dr. Chung's strategic insights and leadership will propel the company towards new horizons of success and innovation in the health IT sector.
  • ROCKVILLE, Md., May 6, 2024 /PRNewswire-PRWeb/ -- Joining the team on April 8, Dr. Davyd Chung brings over two decades of distinguished expertise in strategic growth and business development within the health sector.
  • "Davyd's background in biomedical research and his proven track record in strategic growth are tremendous assets to us," said Hemant Virkar, CEO of Digital Infuzion.

Daré Bioscience Announces Publication in Contraception of Positive Efficacy and Safety Findings from a Pre-Pivotal Postcoital Test Study of Ovaprene®: an Investigational Hormone-Free Monthly Intravaginal Contraceptive

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Giovedì, Aprile 11, 2024
FDA, Birth control, Bangladesh Technical Education Board, NIH, Woman, Human services, NICHD, Trial of the century, Research, Development, CRADA, PCT, Human development, SAN

SAN DIEGO, April 11, 2024 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced the publication of data from the postcoital test clinical study of Ovaprene in two original research articles in the journal Contraception.

Key Points: 
  • “Successful postcoital testing of Ovaprene: An investigational non- hormonal monthly vaginal contraceptive.” Contraception.
  • “Safety Testing of Ovaprene: an Investigational Non-Hormonal Monthly Vaginal Contraceptive.” Contraception.
  • Advance online publication, 110440. https://doi.org/10.1016/j.contraception.2024.110440
    “We are very pleased to have the postcoital test study results for our investigational, hormone-free intravaginal contraceptive Ovaprene published in a leading reproductive health journal,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience.
  • If successful, Daré expects the pivotal study to support marketing approvals of Ovaprene in the U.S. and other countries.

Raydiant Oximetry Secures FDA Approval for Lumerah Investigational Device Exemption (IDE) Study

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Mercoledì, Aprile 10, 2024
FDA, Nerve, Bangladesh Technical Education Board, Investment, Eastern Virginia Medical School, EFS, Pregnancy, NIH, DSM-IV codes, IDE, American Journal, NICHD, Trial of the century, Infant, Dean (education), Female, Obstetrics, Gynaecology, EVMS, CTG, Fetal distress, Pulse oximetry, Mother, Organization, SAN, Woman

“Each year 36,000 babies in the United States suffer neurological damage, which could be prevented through better monitoring tools, such as Lumerah,” says Raydiant Oximetry founder and CEO, Dr. Neil P. Ray.

Key Points: 
  • “Each year 36,000 babies in the United States suffer neurological damage, which could be prevented through better monitoring tools, such as Lumerah,” says Raydiant Oximetry founder and CEO, Dr. Neil P. Ray.
  • Lumerah has received FDA Breakthrough Device Designation for expedited market approval.
  • Completion of the EFS study will pave the path towards FDA IDE approval for a subsequent pivotal study.
  • Raydiant Oximetry is supported by leading organizations that include the March of Dimes and the National Institutes of Health (NIH).

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

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Giovedì, Marzo 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.

The Foundation for the National Institutes of Health Launches First Public-Private Partnership for Early Detection of Preeclampsia

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Lunedì, Febbraio 12, 2024
Health, Family, Consumer, Other Health, Surgery, Other Science, Research, Parenting, Managed Care, General Health, Hospitals, Baby, Maternity, Science, Women, Master of Science, Bangladesh Technical Education Board, FNIH, Merck, Woman, Doctor of Philosophy, NICHD, NIH, Pregnancy, FDA, Partnership, Food, Pre-eclampsia, Mother, Ohio State University, Pappalysin-1, Letter, Risk, Human development, Cedars-Sinai Medical Center, Biomarker, Disorder, Organization, Task force, MPH, Thermo Fisher Scientific, PIGF, Child, Bill, DSM-IV codes, Mortality, George Washington University, Dietary supplement

The Foundation for the National Institutes of Health (FNIH) today announces the launch of a new public-private partnership to develop tools to identify pregnant women at high risk of early-onset preeclampsia.

Key Points: 
  • The Foundation for the National Institutes of Health (FNIH) today announces the launch of a new public-private partnership to develop tools to identify pregnant women at high risk of early-onset preeclampsia.
  • Preeclampsia is a serious pregnancy-related hypertensive disorder that can lead to maternal and neonatal deaths and long-term negative health outcomes.
  • The disorder is becoming more prevalent in the United States, with women of color more likely to be affected and experience poor outcomes.
  • Currently, preeclampsia risk is determined early in pregnancy using a combination of maternal medical history and clinical risk factors.

Daré Bioscience Announces Funding Award Notice from the National Institutes of Health (NIH) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) to Support DARE-PTB1 Phase 1 Human Clinical Study

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Mercoledì, Dicembre 13, 2023
Risk, NICHD, Woman, Estradiol, FDA, Trial of the century, SAN, Doctor of Philosophy, Award, Preterm birth, Clinical trial, Death, NIH, IVR, Pharmaceutical industry

SAN DIEGO, Dec. 13, 2023 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced that it received a Notice of Award of a grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), a division of the National Institutes of Health (NIH). The award will support the clinical development of Daré’s novel, investigational intravaginal ring (IVR), DARE-PTB1. DARE-PTB1 is designed to deliver bio-identical progesterone continuously for up to a 14-day period and is being developed as a treatment for the prevention of preterm birth in at-risk women, for which there are currently no FDA-approved treatments.

Key Points: 
  • The award will support the clinical development of Daré’s novel, investigational intravaginal ring (IVR), DARE-PTB1.
  • “Daré is committed to addressing persistent unmet needs in women’s health and preterm birth is a large category that could benefit from new treatment options to protect women and babies.
  • The content of this press release is solely the responsibility of Daré Bioscience, Inc. and does not necessarily represent the official views of the National Institutes of Health.
  • This press release discusses a project that will be supported by the Eunice Kennedy Shriver National Institute of Child Health & Human Development of the National Institutes of Health under Award Number 4R44HD101169-02.

Daré Bioscience Announces Commencement of Phase 3 Study of Ovaprene®, an Investigational Hormone-Free Monthly Intravaginal Contraceptive

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Lunedì, Dicembre 4, 2023
Food, NICHD, Woman, FDA, Bayer, SAN, Clinical trial, Human services, Hormonal contraception, CRADA, NIH, Safety, Development, Pharmaceutical industry

SAN DIEGO, Dec. 04, 2023 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced commencement of the Company’s pivotal Phase 3 clinical study of Ovaprene, an investigational hormone-free monthly intravaginal contraceptive.

Key Points: 
  • SAN DIEGO, Dec. 04, 2023 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced commencement of the Company’s pivotal Phase 3 clinical study of Ovaprene, an investigational hormone-free monthly intravaginal contraceptive.
  • The multi-center, single arm, non-comparative, pivotal Phase 3 clinical study of Ovaprene will evaluate its effectiveness as a contraceptive along with its safety and usability.
  • If successful, Daré expects the pivotal study to support marketing approvals of Ovaprene in the U.S. and other countries.
  • The agreement gives Daré access to the contraceptive clinical trial expertise of the NICHD clinical trial network while also sharing the costs of the Phase 3 pivotal study with the NICHD.

Daré Bioscience and Premier Research Extend Strategic Partnership to Accelerate the Clinical Development of Daré’s Novel Women’s Health Programs

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Lunedì, Novembre 20, 2023
Cream, Woman, SAN, Food, Human development, Research, FDA, United, CCTN, Birth, NICHD, Trial of the century, Partnership, Fine chemical, Pharmaceutical industry

The agreement was originally established with Health Decisions, Inc., which was acquired by Premier Research in 2021.

Key Points: 
  • The agreement was originally established with Health Decisions, Inc., which was acquired by Premier Research in 2021.
  • “In 2020, Daré and Premier Research conducted a successful Phase 3 clinical study of XACIATO™ (clindamycin phosphate) vaginal gel 2% despite the challenges posed by a global pandemic.
  • “Premier Research is thrilled to renew this partnership and continue our successful work with Daré,” said Michael Arlotto, Ph.D., Chief Operating Officer of Premier Research.
  • “This partnership underscores our joint commitment to advancing women’s health by supporting efforts to include women in clinical research and bring novel products to market.

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

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Giovedì, Novembre 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.

Daré Bioscience Announces Grant Funding Installment to Support Further Development of Novel Contraceptive Technology DARE-LARC1

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Giovedì, Settembre 21, 2023
A Closer Look (Steve Harley & Cockney Rebel album), Human, Use of Free and Open-Source Software (FOSS) in the U.S. Department of Defense, Human services, Office of Inspector General, U.S. Department of Health and Human Services, Birth, CRADA, Clinical trial, Levonorgestrel, MIT, NICHD, Bangladesh Technical Education Board, Trial of the century, Massachusetts Institute of Technology, Development, Bayer, Investigational New Drug, PMA, Cooperative research and development agreement, SAN, Menstrual cycle, Human development, Experience, Eunice Kennedy Shriver National Institute of Child Health and Human Development, FDA, Birth control, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Safety, Pharmaceutical industry, Frederiksen, IND

Under the terms of the grant agreement, Daré may receive a total of up to approximately $49 million to support nonclinical development of DARE-LARC1.

Key Points: 
  • Under the terms of the grant agreement, Daré may receive a total of up to approximately $49 million to support nonclinical development of DARE-LARC1.
  • Daré received an initial $11.5 million payment in 2021 and aggregate payments of approximately $12.4 million in 2022 under the grant agreement.
  • “The DARE-LARC1 product candidate is one of a number of novel contraceptive technologies being developed by Daré,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience.
  • Bayer, in its sole discretion, has the right to make the license effective by paying $20.0 million to Daré.