Organon

Daré Bioscience Announces Grant to Develop Novel Hydrogel Formulation for Delivery of Live Biotherapeutics to Support Vaginal Health

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火曜日, 11月 15, 2022
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SAN DIEGO, Nov. 15, 2022 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced it has received a grant from the Bill & Melinda Gates Foundation (the foundation) of $584,986 to support activities related to development of a vaginal thermosetting gel formulation for the delivery of live biotherapeutics that can be reconstituted at the point of care. If successful, the formulation could be carried forward for further development as a delivery vehicle with potential to enhance the availability of novel therapeutics for vaginal health in the United States and worldwide, including in countries with varying climatic conditions and/or where extended storage may be required.

Key Points: 
  • However, there remains a clear and unmet need for products that can be administered following effective treatment of the primary vaginal infection to then rebalance the vaginal microbiota and promote continued improved vaginal health.
  • This grant will enable us to investigate the use of a novel hydrogel technology to deliver live biotherapeutics to address this challenge that affects women everywhere.
  • We are grateful for the foundations support in advancing this technology with the goal of making such therapies available to women worldwide.
  • Dar cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements.

Daré Bioscience Announces Positive Topline Results from DARE-VVA1 Phase 1/2 Clinical Study

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月曜日, 11月 14, 2022
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SAN DIEGO, Nov. 14, 2022 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced topline data from its Phase 1/2 clinical study of DARE-VVA1, a novel intravaginal proprietary formulation of tamoxifen being developed for the treatment of moderate to severe vulvar and vaginal atrophy. The randomized, double-blind, placebo-controlled study was designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of DARE-VVA1 in postmenopausal participants with moderate to severe VVA. The topline data from the study demonstrated safety and tolerability of DARE-VVA1, as well as improvement in the vaginal cytology parameters and the bothersome vaginal symptoms associated with VVA. DARE-VVA1 has the potential to be the first therapeutic specifically approved for the treatment of VVA in U.S. patients with HR+ breast cancer. There are currently no FDA-approved products labeled for VVA treatment in HR+ breast cancer patients.

Key Points: 
  • We are highly encouraged by the positive topline results of the Phase 1/2 study of DARE-VVA1 as this study is a critical step in developing a potential non-hormonal treatment alternative for VVA, said Dr. Annie Thurman, Medical Director of Dar Bioscience.
  • The Phase 1/2 study evaluated different doses of DARE-VVA1, a tamoxifen vaginal insert, in 17 postmenopausal women with VVA.
  • The study was a randomized, multi-center, double-blind, parallel-arm, placebo-controlled, dose-ranging study that evaluated the safety, tolerability, plasma pharmacokinetics (PK) and pharmacodynamics (PD) of DARE-VVA1.
  • Dar plans to submit data from the Phase 1/2 clinical study of DARE-VVA1 for publication in a peer-reviewed publication.

Organon To Present at the Piper Sandler 34th Annual Healthcare Conference

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火曜日, 11月 15, 2022
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Organon (NYSE: OGN), announced today that Kevin Ali, Chief Executive Officer, and Matthew Walsh, Chief Financial Officer, are scheduled to participate in a fireside chat at the Piper Sandler 34th Annual Healthcare Conference on Tuesday, November 29th, 2022 at 9:00 a.m. EST.

Key Points: 
  • Organon (NYSE: OGN), announced today that Kevin Ali, Chief Executive Officer, and Matthew Walsh, Chief Financial Officer, are scheduled to participate in a fireside chat at the Piper Sandler 34th Annual Healthcare Conference on Tuesday, November 29th, 2022 at 9:00 a.m. EST.
  • Organon is a global healthcare company formed to focus on improving the health of women throughout their lives.
  • Organon has a portfolio of more than 60 medicines and products across a range of therapeutic areas.
  • Organon has a global footprint with significant scale and geographic reach, world-class commercial capabilities, and approximately 10,000 employees with headquarters located in Jersey City, New Jersey.

The Estée Lauder Companies, Organon & Co., and Apex Logic Receive "Tell Awards" for their business investments in Switzerland

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月曜日, 11月 21, 2022
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NEW YORK, Nov. 21, 2022 /PRNewswire/ -- The Este Lauder Companies, Organon & Co., and Apex Logic have each won a 2022 Tell Award from the Swiss authorities, recognizing their significant foreign direct investment in Switzerland, reports Daniel Bangser, Trade Commissioner of Switzerland.

Key Points: 
  • NEW YORK, Nov. 21, 2022 /PRNewswire/ -- The Este Lauder Companies, Organon & Co., and Apex Logic have each won a 2022 Tell Award from the Swiss authorities, recognizing their significant foreign direct investment in Switzerland, reports Daniel Bangser, Trade Commissioner of Switzerland.
  • Ambassador Niculin Jger, The Consul General of Switzerland in New York, and Ambassador Balz Abplanalp, The Consul General of Switzerland in San Francisco, are presenting the awards to the leadership teams of each company.
  • Organon attributes its decision to set up in Lucerne to the opportunities offered in this growing environment for biopharmaceutical innovation.
  • Apex Logic is a privately-owned developer of software for e-commerce and for automating the acquisition process in government that established a European Headquarters in Fribourg in 2020.

OpGen Reports Third Quarter 2022 Financial Results and Provides Business Update

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木曜日, 11月 10, 2022
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Management will host an investor call to discuss quarterly results and provide a business update.

Key Points: 
  • Management will host an investor call to discuss quarterly results and provide a business update.
  • Third Quarter 2022 Financial Results of OpGen, Inc.
    Total revenue for the third quarter of 2022 was approximately $0.4 million, compared with approximately $1.2 million in the third quarter of 2021.
  • Operating expenses for the third quarter of 2022 were approximately $14.0 million, compared with approximately $6.3 million in the third quarter of 2021.
  • OpGens management will host a conference call today, November 10, at 4:30 p.m. EST, to discuss the third quarter financial results and business activities, as well as answer analyst questions.

Daré Bioscience to Present at the Stifel 2022 Healthcare Conference

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火曜日, 11月 8, 2022
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SAN DIEGO, Nov. 08, 2022 (GLOBE NEWSWIRE) -- Dar Bioscience, Inc. (NASDAQ: DARE ), a leader in womens health innovation, today announced that Sabrina Martucci Johnson, the companys President and CEO, will present at the Stifel 2022 Healthcare Conference, being held November 15-16, 2022 in New York, NY.

Key Points: 
  • SAN DIEGO, Nov. 08, 2022 (GLOBE NEWSWIRE) -- Dar Bioscience, Inc. (NASDAQ: DARE ), a leader in womens health innovation, today announced that Sabrina Martucci Johnson, the companys President and CEO, will present at the Stifel 2022 Healthcare Conference, being held November 15-16, 2022 in New York, NY.
  • The webcast will be archived in the same section of the companys website and available for replayuntil November 29, 2022.
  • Dar Bioscience is a biopharmaceutical company committed to advancing innovative products for womens health.
  • The information Dar posts on its investor relations website or through social media channels may be deemed to be material information.

Daré Bioscience to Host Third Quarter 2022 Financial Results and Company Update Conference Call and Webcast on November 10, 2022

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木曜日, 11月 3, 2022
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The live webcast can be accessed under Presentations, Events & Webcasts" in the Investors section of the Company's website at http://ir.darebioscience.com.

Key Points: 
  • The live webcast can be accessed under Presentations, Events & Webcasts" in the Investors section of the Company's website at http://ir.darebioscience.com.
  • Please log in approximately 5-10 minutes prior to the call to register and to download and install any necessary software.
  • Dar Bioscience is a biopharmaceutical company committed to advancing innovative products for womens health.
  • The information Dar posts on its investor relations website or through social media channels may be deemed to be material information.

Daré Bioscience Announces Subject Screening for Phase 2b RESPOND Study of Sildenafil Cream, 3.6% in Women with Female Sexual Arousal Disorder Complete

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火曜日, 11月 1, 2022
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SAN DIEGO, Nov. 01, 2022 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women’s health innovation, and Strategic Science & Technologies, LLC (SST), a Cambridge, MA based novel topical drug delivery company, today announced that subject screening for the exploratory Phase 2b RESPOND clinical study of Sildenafil Cream, 3.6% is complete, allowing for a topline data announcement target of 2Q-2023. The Phase 2b RESPOND clinical study is a multi-center, double-blind, placebo-controlled study to evaluate the efficacy and safety of Sildenafil Cream, 3.6% in premenopausal patients with female sexual arousal disorder (FSAD). A total of approximately 100 subjects have completed all study assessments to date and, based on the subjects that have completed screening, a total of approximately 160 to 170 subjects are expected to complete the study for inclusion in the topline data assessment targeted for 2Q-2023.

Key Points: 
  • The Phase 2b RESPOND clinical study is a multi-center, double-blind, placebo-controlled study to evaluate the efficacy and safety of Sildenafil Cream, 3.6% in premenopausal patients with female sexual arousal disorder (FSAD).
  • Sildenafil Cream is a proprietary topical formulation of sildenafil, a phosphodiesterase-5 (PDE-5) inhibitor, being developed as a first-in-category option for the treatment of FSAD.
  • We look forward to evaluating the topline data next year, said Sabrina Martucci Johnson, President and CEO of Dar Bioscience.
  • Increasing blood flow to the genital tissue, as Sildenafil Cream is designed to do, has the potential to improve genital arousal response and overall sexual experience for women.

Organon To Report Third Quarter Results and Host Conference Call on November 3, 2022

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木曜日, 10月 20, 2022
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Organon (NYSE: OGN), a global womens healthcare company will release its third quarter 2022 financial results on November 3, 2022, prior to the companys webcast and conference call scheduled for 8:30 a.m. EDT.

Key Points: 
  • Organon (NYSE: OGN), a global womens healthcare company will release its third quarter 2022 financial results on November 3, 2022, prior to the companys webcast and conference call scheduled for 8:30 a.m. EDT.
  • Interested parties may access the live call via webcast on the Organon website at https://www.organon.com/investor-relations/events-and-presentations/ .
  • A replay of the webcast will be available approximately two hours after the conclusion of the live event on the companys website.
  • Institutional investors and analysts interested in participating in the call must register in advance using conference ID# 58511-502 and by clicking on this link: https://conferencingportals.com/event/ZGyfDfjk .

PRODUCTLIFE GROUP ANNOUNCES ACQUISITION OF ZWIERS REGULATORY CONSULTANCY AND COVERAGE EXPANSION TO THE NETHERLANDS

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火曜日, 10月 18, 2022
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PARIS, Oct. 18, 2022 /PRNewswire/ -- ProductLife Group (PLG), the global provider of regulatory, vigilance and quality services for the Pharmaceutical, Medtech and Biotech industries announces the acquisition of Zwiers Regulatory Consultancy - a consultancy specialising in regulatory affairs, pharmacovigilance and integrated development for drugs and devices with offices in Amsterdam and Oss, the Netherlands.

Key Points: 
  • PARIS, Oct. 18, 2022 /PRNewswire/ --ProductLife Group (PLG), the global provider of regulatory, vigilance and quality services for the Pharmaceutical, Medtech and Biotech industries announces the acquisition of Zwiers Regulatory Consultancy - a consultancy specialising in regulatory affairs, pharmacovigilance and integrated development for drugs and devices with offices in Amsterdam and Oss, the Netherlands.
  • Since 2011, Zwiers Regulatory Consultancy has established a reputation as a strategic partner in the life sciences industry.
  • Through this acquisition, PLG immediately expands and substantially enhances its comprehensive suite of drug development services and medical device expertise.
  • ProductLife Group's mission is to improve human health by delivering regulatory & compliance services for the safe and effective use of medical solutions.