Estradiol

Knight Therapeutics Announces Launch of Bijuva® in Canada

Retrieved on: 
Tuesday, February 6, 2024
VMS, GUD, Uterus, Estradiol, Pan-American, Progesterone, Patient, Hot, TSX, Therapy, Capsule, Menopause, Hormone, Woman

MONTREAL, Feb. 06, 2024 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc., (TSX: GUD) ("Knight"), a Pan-American (ex-USA) specialty pharmaceutical company, announced today the launch of BIJUVA® (estradiol and progesterone) capsules in Canada.

Key Points: 
  • MONTREAL, Feb. 06, 2024 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc., (TSX: GUD) ("Knight"), a Pan-American (ex-USA) specialty pharmaceutical company, announced today the launch of BIJUVA® (estradiol and progesterone) capsules in Canada.
  • VMS affects 60% to 80% of women entering menopause1 and are commonly known as hot flashes or flushes and night sweats.
  • Knight and TherapeuticsMD signed a license agreement in July 2018 pursuant to which TherapeuticsMD granted Knight the exclusive Canadian commercialization rights to BIJUVA®.
  • Under the terms of the license agreement related BIJUVA® in Canada, Knight will pay TherapeuticsMD sales milestone fees and royalties based upon certain aggregate annual sales of BIJUVA® in Canada.

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 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

Retrieved on: 
Wednesday, December 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.

The Paul G. Allen Family Foundation awards $10.5 million to new Allen Distinguished Investigators

Retrieved on: 
Tuesday, November 21, 2023
Medicine, Brain, Genetics, Research, Behavior, Reproduction, Hormone, Immune system, Inflammation, Testosterone, Allen Institute, EVS, Immunity, Microscopy, B cell, Disease, Protein, Learning, Mortality, Cardiovascular disease, Glossary of biology, Extracellular vesicle, Lipoprotein, Male, Neuron, Map, Animal, Machine learning, Health, COVID-19, Seminal vesicles, Ageing, Administration, Infection, Estradiol, Mammal, Neuroendocrinology, EV, DSM-IV codes, Skin, Female, Innovation, Cell, Biology, Traffic barrier, Pharmaceutical industry, Vaccine, Fireworks, Birth control, Science

18 researchers will develop technologies, design approaches and uncover insights into fundamental areas of human biology

Key Points: 
  • 18 researchers will develop technologies, design approaches and uncover insights into fundamental areas of human biology
    The Paul G. Allen Family Foundation will award $1.5 million to seven research projects which 18 researchers will lead.
  • "Our two newest cohorts of Allen Distinguished Investigators are using innovative technologies and unprecedented ambition to pioneer new frontiers in the fields of sex hormones and extracellular vesicles.
  • said Kathy Richmond , Ph.D., M.B.A., Executive Vice President and Director of the Frontiers Group and the Office of Science and Innovation at the Allen Institute.
  • Including the new awards, a total of 130 Allen Distinguished Investigators have been appointed during the past 12 years.

ANI Pharmaceuticals Announces the FDA Approval and Launch of Estradiol Tablets USP

Retrieved on: 
Tuesday, September 12, 2023
Abbreviated New Drug Application, ANI, Food and Drug Administration, Tablet, RLD, Estradiol, Patient, Estradiol valerate, ANDA, FDA, Food, Pharmaceutical industry, IQVIA

BAUDETTE, Minn., Sept. 12, 2023 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Estradiol Tablets USP.

Key Points: 
  • BAUDETTE, Minn., Sept. 12, 2023 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that it received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Estradiol Tablets USP.
  • ANI’s Estradiol Tablets USP are the generic version of the Reference Listed Drug (RLD) Estrace®.
  • The According to IQVIA, a leading healthcare data and analytics provider, the current annual U.S. market for Estradiol Tablets USP is approximately $40.9 million.
  • “The approval and launch of Estradiol Tablets, so quickly following our launch last month of Estradiol Gel, exemplifies the ongoing strength of ANI’s Generics portfolio as well as our ongoing commitment in ensuring that patients and providers have access to the high-quality medications they depend on,” stated Nikhil Lalwani, President and Chief Executive Officer of ANI.

Optimizing Sleep During Perimenopause and Beyond, Upcoming Webinar Hosted by Xtalks

Retrieved on: 
Wednesday, September 13, 2023
Cognitive behavioral therapy, Sleep, Prevalence, Overalls, Menopause, Woman, SRI, Estradiol, Doctor of Philosophy, Hot, SRI International, Insomnia, Risk, Heart rate, Health, Oklahoma State University Center for Health Sciences, Pharmaceutical industry, Birth control

TORONTO, Sept. 13, 2023 /PRNewswire-PRWeb/ -- Sleep is essential for overall health and emotional well-being. During perimenopause, dramatic hormonal changes occur and vasomotor symptoms (e.g., hot flashes) become prominent, as well as increasing prevalence of primary sleep and other physical and mental health disorders.

Key Points: 
  • In this free webinar, learn about what sleep health is and why it is important in the context of women's health.
  • Find out about the hormonal changes across the menopausal transition and how they affect sleep.
  • Attendees will hear about effective management strategies for sleep disturbances and insomnia in the context of menopause.
  • During perimenopause, dramatic hormonal changes occur and vasomotor symptoms (e.g., hot flashes) become prominent, as well as increasing prevalence of primary sleep and other physical and mental health disorders.

Entera Bio to Present Two Abstracts on its First-in-Class, Once Daily Oral hPTH(1-34) Peptide Tablets (EB613) for the Treatment of Post-Menopausal Women at High Risk of Fracture at the American Society for Bone and Mineral Research (ASBMR) Annual Meeting

Retrieved on: 
Wednesday, August 16, 2023
Bone fracture, Osteoporosis, Cardiovascular disease, Cancer, Woman, Estradiol, Entera, Tablet, Patient, Risk, Annual general meeting, Menopause, Rare-earth element, Dietary supplement

EB613 [hPTH(1-34) tablets] is being developed as the first once-daily oral anabolic (bone forming) mini tablet therapy for post-menopausal women with high risk osteoporosis.

Key Points: 
  • EB613 [hPTH(1-34) tablets] is being developed as the first once-daily oral anabolic (bone forming) mini tablet therapy for post-menopausal women with high risk osteoporosis.
  • Due to a lower peak bone density as compared to men and decreases in estradiol after menopause, women are affected in greater numbers.
  • Post menopausal osteoporosis afflicts more women globally than cancer and cardiovascular disease and is a serious health concern.
  • As potentially, the first once daily hPTH(1-34) peptide tablet therapy, our EB613 program is dedicated to address the vast treatment gap in current osteoporosis care,” said Miranda Toledano, Chief Executive Officer at Entera.

InsideTracker, a Leading Health Tech Company, Expands Offerings to Include Insulin Testing as an Early Warning for Several Chronic Diseases

Retrieved on: 
Thursday, July 6, 2023
Cognition, Exercise, TSH, DNA, Insulin, Obesity, Diet, Liver disease, Glycogen, Cancer, Type 2 diabetes, Oura Health, Meal, Dicarboxylic acid, Estradiol, Alzheimer's disease, Biomarker, Metabolic syndrome, Risk, Conditional sentence, Growth, Progesterone, Health, Kidney disease, Glycated hemoglobin, Dietary supplement, Pharmaceutical industry, Medical device, Science

CAMBRIDGE, Mass., July 6, 2023 /PRNewswire/ -- InsideTracker, the leading personal health analysis and data-driven wellness guide that helps people live healthier longer, announced today its Ultimate Plan will now also measure insulin—a key to sustained energy and an early warning for several chronic diseases.

Key Points: 
  • InsideTracker's comprehensive health analysis now includes up to 48 biomarkers, a DNA test, and activity tracker integration for the most holistic assessment of your health.
  • Despite playing multiple essential roles in the body, insulin is currently an underutilized measure of metabolic health in preventive and proactive care.
  • "Elevated levels can be an indication of the early stages of insulin resistance—even in individuals with fasted glucose and HbA1c in clinically normal ranges.
  • Fasted insulin levels also tend to creep up with age, increasing your risk of developing type-2 diabetes mellitus.

Wellcore Introduces Pain-Free, At-Home Hormone Optimization Program for Women

Retrieved on: 
Thursday, June 29, 2023
DHEA, Bioidentical hormone replacement therapy, Hormone replacement therapy, Osteoporosis, Clinical trial, Medicine, Brain, Estradiol, Attention, Libido, Biomarker, Weight gain, Hot, WHI, Sleep, HRT, Capsule, Cancer, Testosterone, Progesterone, Pain, Safety, Birth control, Woman

AUSTIN, Texas, June 29, 2023 /PRNewswire/ -- Wellcore, a science-backed at-home hormone optimization program for men, has introduced a women's program built on the same principles: wellness, accessibility, personalization and most importantly, safety. The comprehensive program elevates industry standards by providing painless at-home hormone assessments along with ongoing, proactive testing of 22 biomarkers. This helps identify imbalances with more accuracy than other at-home services, which are then treated with a personalized hormone optimization protocol.

Key Points: 
  • The comprehensive program elevates industry standards by providing painless at-home hormone assessments along with ongoing, proactive testing of 22 biomarkers.
  • This helps identify imbalances with more accuracy than other at-home services, which are then treated with a personalized hormone optimization protocol.
  • The Wellcore women's program is currently available in Alaska, Arizona, California, Minnesota, Nevada, New Jersey, New York, North Carolina, Pennsylvania and Texas.
  • The all-inclusive hormone optimization program which entails all future lab work, consultations and shipping is $225 per month and billed quarterly.

Daré Bioscience Announces Publication in Menopause: The Journal of The North American Menopause Society of Data from Phase 1/2 Open-Label Safety and Pharmacokinetics Study of DARE-HRT1 in Healthy Postmenopausal Women

Retrieved on: 
Wednesday, June 21, 2023
IVR, Hot, VMS, North American Menopause Society, P4, Pharmacokinetics, Woman, Estradiol, Harvard Medical School, Massachusetts Institute of Technology, Journal, Dick's Picks Volume 30, SAN, Hospital, Progesterone, FDA, Massachusetts General Hospital, Food, Safety, Pharmaceutical industry, Menopause, IND

SAN DIEGO, June 21, 2023 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced the publication in Menopause: The Journal of The North American Menopause Society of data from a Phase 1/2 clinical trial that evaluated the safety and pharmacokinetics of DARE-HRT1. DARE-HRT1, an investigational intravaginal ring (IVR) designed to release bio-identical 17β2-estradiol (E2) and bio-identical progesterone (P4) continuously over a 28-day period as part of a hormone therapy regimen, is part of Daré’s proprietary IVR technology platform originally developed by Dr. Robert Langer from the Massachusetts Institute of Technology and Dr. William Crowley from Massachusetts General Hospital and Harvard Medical School.

Key Points: 
  • SAN DIEGO, June 21, 2023 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced the publication in Menopause: The Journal of The North American Menopause Society of data from a Phase 1/2 clinical trial that evaluated the safety and pharmacokinetics of DARE-HRT1.
  • Data from the study support continued clinical development of DARE-HRT1 for the treatment of menopausal symptoms.
  • “Guidance from the North American Menopause Socierty asserts that hormone therapy remains the most effective treatment for vasomotor symptoms.
  • Ongoing activities to support progressing directly into a single Phase 3 study to support registration include manufacturing and non-clinical studies to support the IND submission and the planned IND-opening Phase 3 study.