Climacteric

Nika Pharmaceuticals, Inc. (NKPH) Purchased the Technologies for Three Drugs in Tablet Form and One Dietary Supplement

Retrieved on: 
Monday, April 15, 2024

HENDERSON, Nev., April 15, 2024 (GLOBE NEWSWIRE) -- Nika Pharmaceuticals, Inc. (OTCMKTS: NKPH) announces the purchase of four technologies for production of three generic drugs in tablet form and one dietary supplement.

Key Points: 
  • HENDERSON, Nev., April 15, 2024 (GLOBE NEWSWIRE) -- Nika Pharmaceuticals, Inc. (OTCMKTS: NKPH) announces the purchase of four technologies for production of three generic drugs in tablet form and one dietary supplement.
  • The acquisition includes full dossiers for each product, which will allow NKPH to quickly register them for sale once the company has finalized the branding of each.
  • The technologies, which were purchased through NKPH’s subsidiary, Nika Europe Ltd., have a proven market track record, as each of them satisfy an important health need of the population.
  • MENTHYL VALERATE 60mg is an over-the-counter drug with a positive effect on the central nervous and cardiovascular systems.

Dr. Wolff's Vagisan Introduces Hormone-Free Moisturising Cream and Moisturising Cremolum, Clinically Proven to Soothe Vaginal Dryness

Retrieved on: 
Thursday, October 19, 2023

Hong Kong SAR, China--(Newsfile Corp. - October 19, 2023) - Dr. Wolff's Vagisan introduces hormone-free Moisturising Cream and Moisturising Cremolum for women troubled by vaginal dryness while experiencing menopause.

Key Points: 
  • Hong Kong SAR, China--(Newsfile Corp. - October 19, 2023) - Dr. Wolff's Vagisan introduces hormone-free Moisturising Cream and Moisturising Cremolum for women troubled by vaginal dryness while experiencing menopause.
  • Vaginal secretions gradually decrease as a woman ages, resulting in decreased lubrication and elasticity of the vaginal tissue.
  • This can result in vaginal dryness and associated symptoms such as dryness, itching, burning, and pain3.
  • Vaginal hormone-free moisturising cream is not inferior to an estriol cream for treating symptoms of vulvovaginal atrophy: Prospective, randomised study.

Dr. Wolff Group: Dr. Wolff’s Vagisan introduces hormone-free Moisturising Cream and Moisturising Cremolum, clinically proven to soothe vaginal dryness

Retrieved on: 
Thursday, October 26, 2023

Dr. Wolff Group: Dr. Wolff’s Vagisan introduces hormone-free Moisturising Cream and Moisturising Cremolum, clinically proven to soothe vaginal dryness

Key Points: 
  • Dr. Wolff Group: Dr. Wolff’s Vagisan introduces hormone-free Moisturising Cream and Moisturising Cremolum, clinically proven to soothe vaginal dryness
    The issuer is solely responsible for the content of this announcement.
  • Dr. Wolff’s Vagisan introduces hormone-free Moisturising Cream and Moisturising Cremolum, clinically proven to soothe vaginal dryness
    HONG KONG SAR - Media OutReach - 18 October 2023 - Many woman experiencing menopause are troubled by vaginal dryness.
  • This can result in vaginal dryness and associated symptoms such as dryness, itching, burning, and pain3.
  • Vaginal hormone-free moisturising cream is not inferior to an estriol cream for treating symptoms of vulvovaginal atrophy: Prospective, randomised study.

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

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.

Daré Bioscience Announces Publication of Positive Safety and Acceptability Data from Phase 1 Clinical Trial that Support the Potential of DARE-HRT1 Intravaginal Ring as a New Menopausal Hormone Therapy

Retrieved on: 
Tuesday, April 18, 2023

SAN DIEGO, April 18, 2023 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced that Climacteric, the official journal of the International Menopause Society, published safety and acceptability results from a Phase 1 clinical trial of DARE-HRT1, an investigational ethylene vinyl acetate copolymer intravaginal ring (IVR) designed to release bio-identical 17β-estradiol (E2) and progesterone (P4) over 28 days. DARE-HRT1 is being developed for the treatment of moderate-to-severe vasomotor symptoms (VMS) due to menopause in women with intact uteri.

Key Points: 
  • DARE-HRT1 is being developed for the treatment of moderate-to-severe vasomotor symptoms (VMS) due to menopause in women with intact uteri.
  • Hormone therapy is used to treat VMS and genitourinary syndrome associated with menopause.
  • DARE-HRT1 has the potential to be the first FDA-approved product to offer vaginal delivery of combination bio-identical estradiol and bio-identical progesterone hormone therapy in a convenient monthly format.
  • The primary objective of the study was to assess the pharmacokinetics from the two dosage strengths of the DARE-HRT1 IVRs.

Astellas to Present Findings from Phase 3 Long-Term Safety Study of Fezolinetant in Oral Session at The North American Menopause Society 2022 Annual Meeting

Retrieved on: 
Wednesday, October 12, 2022

TOKYO, Oct. 12, 2022 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") will present 52-week results from the Phase 3 SKYLIGHT 4™ clinical study evaluating the safety and tolerability of fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. The results will be featured in an oral presentation October 13 at The North American Menopause Society Annual Meeting. VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause.1,2

Key Points: 
  • SKYLIGHT 4 ( NCT04003389 ) is a 52-week double-blinded, placebo-controlled study designed to investigate the long-term safety of fezolinetant.
  • There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated.
  • Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world.
  • A phase 2b, randomized, placebo-controlled, double-blind, dose-ranging study of the neurokinin 3 receptor antagonist fezolinetant for vasomotor symptoms associated with menopause.

European Medicines Agency Accepts Astellas' Marketing Authorization Application for Fezolinetant

Retrieved on: 
Friday, September 30, 2022

TOKYO, Sept. 29, 2022 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced the European Medicines Agency (EMA) has accepted for regulatory review the company's marketing authorization application (MAA) for fezolinetant, an investigational oral, nonhormonal compound seeking approval for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause.1,2

Key Points: 
  • Data from the SKYLIGHT 4 safety study further characterizes the long-term safety profile of fezolinetant.
  • The safety and efficacy of fezolinetant are under investigation and have not been established.
  • The BRIGHT SKY pivotal trials, SKYLIGHT 1 ( NCT04003155 ) and SKYLIGHT 2 ( NCT04003142 ), enrolled over 1,000 women with moderate to severe VMS.
  • SKYLIGHT 4 ( NCT04003389 ) is a 52-week double-blinded, placebo-controlled study designed to investigate the long-term safety of fezolinetant.

Daré Bioscience Initiates Phase 1/2 Clinical Study of DARE-HRT1

Retrieved on: 
Tuesday, April 12, 2022

SAN DIEGO, April 12, 2022 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced the initiation of a Phase 1/2 clinical study of DARE-HRT1.

Key Points: 
  • SAN DIEGO, April 12, 2022 (GLOBE NEWSWIRE) -- DarBioscience, Inc. (NASDAQ: DARE), a leader in womens health innovation, today announced the initiation of a Phase 1/2 clinical study of DARE-HRT1.
  • Baseline-corrected steady state release level data from the prior Phase 1 study demonstrate that both dose versions of DARE-HRT1 successfully delivered two different bio-identical hormones over the 28-day evaluation period.
  • Dar Bioscience is a biopharmaceutical company committed to advancing innovative products for womens health.
  • Dar cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements.

Theramex Enters OTC Market with Femarelle®, a Non-hormonal Option to Treat Menopause Symptoms

Retrieved on: 
Monday, November 15, 2021

Theramex, a company dedicated womens health, recently acquired the Femarelle product licence to treat menopause symptoms.

Key Points: 
  • Theramex, a company dedicated womens health, recently acquired the Femarelle product licence to treat menopause symptoms.
  • Femarelle offers non-hormonal therapy to balance oestrogen levels in women from peri-menopause through menopause to post-menopause relieving the symptoms and conditions derived from oestrogen loss with the onset of menopause.
  • With this move, Theramex steps up its commitment to provide women with an effective and safe alternative to menopause hormone therapy.
  • Snchez-Borrego R., Mendoza N., Llaneza P. A prospective study of DT56a (Femarelle) for the treatment of menopause symptoms; Climacteric.

Jiuye SCM Presents Fruit Ripening and Shipping Expertise at IFEX Philippines

Retrieved on: 
Thursday, June 6, 2019

MANILA,Philippines, June 5, 2019 /PRNewswire/ -- Jiuye Supply Chain Management ("Jiuye SCM" or "the Company"),China'sleading cold chain service provider, showcased its fruit ripening and shipping expertise at the IFEX Philippines, a major export-oriented food show and platform for buyers and grocers in Asia, held from May 24 to 26 in Manila.

Key Points: 
  • MANILA,Philippines, June 5, 2019 /PRNewswire/ -- Jiuye Supply Chain Management ("Jiuye SCM" or "the Company"),China'sleading cold chain service provider, showcased its fruit ripening and shipping expertise at the IFEX Philippines, a major export-oriented food show and platform for buyers and grocers in Asia, held from May 24 to 26 in Manila.
  • With years of experience in shipping climacteric fruits, Jiuye SCM is adept at fruit ripening and distribution.
  • The Company can provide strong support for fruit suppliers from the Philippines and further afield to help them expand in China with its mature and well-designed ripening and shipping services.
  • Jiuye SCM currently operates fruit ripening and shipping businesses in Southeast Asia, Japan and North America.