Progestogens

Daré Announces Collaborative Research Agreement (CRADA) for the Pivotal Phase 3 Study of Ovaprene®, an Investigational Hormone-Free Monthly Contraceptive

Retrieved on: 
Monday, July 12, 2021

The agreement will allow Dar to leverage the contraceptive clinical trial expertise of NICHD while also sharing the costs of the Phase 3 pivotal study with NICHD.

Key Points: 
  • The agreement will allow Dar to leverage the contraceptive clinical trial expertise of NICHD while also sharing the costs of the Phase 3 pivotal study with NICHD.
  • The pivotal Phase 3 study will be supported by the NICHDs Contraceptive Development Program (CDP).
  • Under the CRADA, Dar has also agreed to contribute $5.5 million toward the total estimated cost to conduct the pivotal Phase 3 study, which will be payable in four payments.
  • The multi-center, single arm, non-comparative, pivotal Phase 3 contraceptive study of Ovaprene will evaluate its effectiveness as a contraceptive device along with its safety and usability.

DGAP-News: APONTIS PHARMA marks further success in the roll-out of Single Pill therapy

Retrieved on: 
Monday, July 12, 2021

Ultimately, patients benefit from a Single Pill treatment versus a multi pill regimen.

Key Points: 
  • Ultimately, patients benefit from a Single Pill treatment versus a multi pill regimen.
  • Therefore, the prescribed medication is taken more reliably when the dosage form is limited to a Single Pill.
  • The Single Pill therapy is evidence-based more efficient and ensures a more sustainable treatment success.
  • Since 2013, APONTIS successfully launched several Single Pill products alone for cardiovascular indications such as hypertension, hyperlipidemia and secondary prevention.

Women can buy Maxwellia's Lovima® contraceptive pill from pharmacies without a prescription for first time in UK history

Retrieved on: 
Thursday, July 8, 2021

The progestogen-only pill is an effective form of oral contraceptiontrusted by millions of women.

Key Points: 
  • The progestogen-only pill is an effective form of oral contraceptiontrusted by millions of women.
  • It is clear that the limited and restricted way women can currently access contraception isn't working for many of them.
  • When the contraceptive pill was first made available in the UK 60 years ago this year, doctors were only allowed to prescribe it to married women.
  • Available at: https://ec.europa.eu/eurostat/web/products-eurostat-news/-/DDN-20170808-1 8th August 2017 [Accessed 17 March 2021]
    v. Maxwellia Lovima survey conducted by Censuswide w/e 27thNovember 2020, 1,009 total UK female respondents aged 18-55

Global Uterine Fibroids Clinical Landscape Market Report 2021 - ResearchAndMarkets.com

Retrieved on: 
Tuesday, June 15, 2021

This Market Spotlight report covers the Uterine Fibroids market, comprising key marketed and pipeline drugs, clinical trials, recent events and analyst opinion, upcoming and regulatory events, probability of success, a 10-year disease prevalence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.

Key Points: 
  • This Market Spotlight report covers the Uterine Fibroids market, comprising key marketed and pipeline drugs, clinical trials, recent events and analyst opinion, upcoming and regulatory events, probability of success, a 10-year disease prevalence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.
  • Lupron, Orgovyx, and ORIAHNN, which target gonadotropin-releasing hormone receptor, and ulipristal acetate, which targets progesterone receptor, are the only approved drugs for uterine fibroids.
  • The largest proportion of industry-sponsored drugs in active clinical development for uterine fibroids are in Phase III, with one drug in the NDA/BLA phase.
  • Repros Therapeutics has the highest number of completed clinical trials for uterine fibroids, with 17 trials.

Affron Associated with Improvements in Psychological Symptoms of Menopause According to New Study

Retrieved on: 
Tuesday, June 15, 2021

The saffron extract, administered for 12 weeks at 28 mg at day, was associated with greater improvements in psychological symptoms.

Key Points: 
  • The saffron extract, administered for 12 weeks at 28 mg at day, was associated with greater improvements in psychological symptoms.
  • Affron is produced and marketed by Pharmactive using green proprietary technology to extract pure, highly concentrated saffron.
  • "This is the first study of affron examining menopause symptoms in average perimenopausal women," explains Alberto Espinel, Manager of Strategic R&D in Active and Functional Natural Ingredients for Pharmactive.
  • "This means that in comparison to other botanical extracts that target menopause symptoms, affron doesn't have undesirable estrogenic effects.

Deciphera Pharmaceuticals Presents Data from QINLOCK® and Rebastinib Programs at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting

Retrieved on: 
Friday, June 4, 2021

Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a commercial-stage biopharmaceutical company developing innovative medicines to improve the lives of people with cancer, today announced two e-poster presentations at the 2021 ASCO Annual Meeting.

Key Points: 
  • Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a commercial-stage biopharmaceutical company developing innovative medicines to improve the lives of people with cancer, today announced two e-poster presentations at the 2021 ASCO Annual Meeting.
  • As of a March 19, 2021 cutoff date, 38 patients with endometrial cancer initiated treatment with rebastinib in combination with weekly paclitaxel 80 mg/m2.
  • Of the 38 patients with endometrial cancer who initiated treatment with rebastinib, the median duration of treatment was 3.7 months.
  • QINLOCK and the QINLOCK logo are registered trademarks, and Deciphera and the Deciphera logo are trademarks, of Deciphera Pharmaceuticals, LLC.

Organon Canada Launches as New Women's Health Company

Retrieved on: 
Thursday, June 3, 2021

KIRKLAND, QC, June 3, 2021 /CNW/ - Organon (NYSE: OGN), today celebrates its launch as the only global company of its size focused on women's health.

Key Points: 
  • KIRKLAND, QC, June 3, 2021 /CNW/ - Organon (NYSE: OGN), today celebrates its launch as the only global company of its size focused on women's health.
  • The company aims to become a champion of women's health in Canada as well as a leader in the field of biosimilars.
  • We are launching with a strong portfolio in women's health bringing therapeutic options to women in Canada," explains Michael Casia, President and Managing Director, Organon Canada.
  • Organon has three core pillars which will benefit from renewed management focus and commercial investment:
    Women's Health: Organon Canada will be continuing to launch Nexplanon, a contraceptive implant, one of the key growth drivers for the company which was made available late last year in Canada.

Radius Health Business Update

Retrieved on: 
Wednesday, June 2, 2021

TYMLOS new patient adds in April: modest growth vs. previous 4-month trailing averages

Key Points: 
  • TYMLOS new patient adds in April: modest growth vs. previous 4-month trailing averages
    Meaningful FDA guidance on generic peptide requirements published on May 19, 2021
    Anticipate abaloparatide depot formulation technical development work to commence 2H, 2021
    BOSTON, June 02, 2021 (GLOBE NEWSWIRE) -- Radius Health, Inc. (Radius or the Company) (NASDAQ: RDUS), provided a business update covering continued progress for the Company.
  • Additional business updates will be provided as progress is achieved.
  • Radius views this new guidance as meaningful in assessing the probability of a generic synthetic peptide being filed and gaining market entry.
  • Radius lead product, TYMLOS (abaloparatide) injection, was approved by the U.S. Food and Drug Administration for the treatment of postmenopausal women with osteoporosis at high risk for fracture.

TherapeuticsMD Announces Submission of Low Dose BIJUVA® 0.5 mg/100 mg Supplemental New Drug Application to FDA

Retrieved on: 
Tuesday, May 25, 2021

TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative, leading womens healthcare company, announced today that the Company submitted a supplemental New Drug Application (sNDA) for BIJUVA (estradiol and progesterone) capsules, 0.5 mg/100 mg, to the U.S. Food and Drug Administration (FDA).

Key Points: 
  • TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative, leading womens healthcare company, announced today that the Company submitted a supplemental New Drug Application (sNDA) for BIJUVA (estradiol and progesterone) capsules, 0.5 mg/100 mg, to the U.S. Food and Drug Administration (FDA).
  • We are pleased to have identified a path forward for submission to the FDA of our sNDA for low-dose BIJUVA.
  • BIJUVA is the only FDA-approved bio-identical hormone therapy combination of estradiol and progesterone in a single, oral capsule.
  • To learn more about TherapeuticsMD, please visit therapeuticsmd.com or follow us on Twitter: @TherapeuticsMD and on Facebook: TherapeuticsMD.

Aurinia To Present Supportive AURORA 2 Continuation Study Interim Analysis Demonstrating Long-Term Safety & Efficacy of LUPKYNIS™ (voclosporin) in Subjects with Lupus Nephritis

Retrieved on: 
Thursday, May 20, 2021

The interim analysis to be presented at EULAR evaluated subjects with up to two years of total treatment: one year from AURORA 1 and up to one year in AURORA 2.

Key Points: 
  • The interim analysis to be presented at EULAR evaluated subjects with up to two years of total treatment: one year from AURORA 1 and up to one year in AURORA 2.
  • Data from 124 subjects (73 voclosporin; 51 control arm) who had received 104 weeks of continuous treatment was analyzed.
  • A greater reduction in proteinuria between arms was also observed between 1 and 2 years (1.0 vs 0.6 mg/mg; voclosporin vs control).
  • Renal function as determined by eGFR remained stable over 104 weeks in both groups compared to baseline assessments.