Vaginal yeast infection

Mycovia Pharmaceuticals, Inc. Announces Partner Jiangsu Hengrui Pharmaceuticals Co., Ltd's Commercial Launch of VIVJOA® (Oteseconazole) Capsules for the Treatment of Severe Vulvovaginal Candidiasis (VVC) in China

Retrieved on: 
Wednesday, February 7, 2024

DURHAM, N.C., Feb. 7, 2024 /PRNewswire/ -- Mycovia Pharmaceuticals, Inc. ("Mycovia"), an emerging biopharmaceutical company, today announced that Jiangsu Hengrui Pharmaceuticals Co., Ltd ("Hengrui") has commercially launched VIVJOA® (oteseconazole) in China, making available an innovative oral azole antifungal indicated for the treatment of severe vulvovaginal candidiasis (VVC). VIVJOA is contraindicated for females of reproductive potential, pregnant and lactating women, and patients with known hypersensitivity to active ingredients, excipients, and azoles.

Key Points: 
  • VIVJOA is contraindicated for females of reproductive potential, pregnant and lactating women, and patients with known hypersensitivity to active ingredients, excipients, and azoles.
  • "The disease burden in China is significant, and access to VIVJOA provides health care providers and women suffering with severe VVC a new treatment option."
  • Vulvovaginal candidiasis is an exceedingly common mucosal infection usually caused by Candida albicans but can occasionally be caused by other Candida species or yeasts.
  • In April 2022, the U.S. Food and Drug Administration (FDA) approved VIVJOA (oteseconazole) Capsules as the first medication for Recurrent Vulvovaginal Candidiasis (RVVC, or chronic yeast infection).

Vulvovaginal Candidiasis Treatment Research Report 2023 - ResearchAndMarkets.com

Retrieved on: 
Tuesday, October 10, 2023

The increasing demand for vulvovaginal candidiasis treatment can be attributed to several key factors driving its growth.

Key Points: 
  • The increasing demand for vulvovaginal candidiasis treatment can be attributed to several key factors driving its growth.
  • Furthermore, the global population's growing awareness of the need for effective yet cost-efficient treatment options, particularly among the elderly demographic, has led to a surge in demand for vulvovaginal candidiasis treatment on a global scale.
  • The market's growth is further driven by the rising prevalence of acute vulvovaginal candidiasis infections among the global population, with an increasing number of research initiatives aimed at understanding the prevalence of conditions like recurrent vulvovaginal candidiasis (RVVC).
  • Company Profiles: Detailed analysis of the major companies present in Global Vulvovaginal Candidiasis Treatment Market.

Concerto Biosciences Expands Executive Leadership Team To Support Product Development And Business Partnership Initiatives

Retrieved on: 
Wednesday, July 26, 2023

CAMBRIDGE, Mass., July 26, 2023 /PRNewswire/ -- Concerto Biosciences today announced the addition of three key positions to the company's Executive Leadership Team. Dr. Roger Frechette will serve as Chief Business Officer while Jim Sigler joins as Executive Vice President of Chemistry, Manufacturing, and Controls (CMC). Dr. Bernardo Cervantes, a cofounder of Concerto, transitions into the role of Chief Operating Officer.

Key Points: 
  • Concerto adds Chief Business Officer, Chief Operations Officer, and Executive Vice President of CMC to Executive Leadership Team, accelerating momentum for first-in-human trials, strategic partnerships
    CAMBRIDGE, Mass., July 26, 2023 /PRNewswire/ -- Concerto Biosciences today announced the addition of three key positions to the company's Executive Leadership Team.
  • Dr. Roger Frechette will serve as Chief Business Officer while Jim Sigler joins as Executive Vice President of Chemistry, Manufacturing, and Controls (CMC).
  • "Their addition to the Leadership Team drives Concerto's success in two major ways: preparing for our first in-human trial in 2024 and expanding our portfolio of partnership-driven product discovery programs."
  • Dr. Frechette is a veteran life science executive with extensive experience in strategic planning and business development.

Pooled Data from the Pivotal Phase 3 VANISH Program Published in the Journal of Women’s Health Demonstrate Significant Efficacy of Ibrexafungerp Over Placebo for Treatment of Vaginal Yeast Infection

Retrieved on: 
Thursday, November 3, 2022

Ibrexafungerp demonstrated consistent efficacy in important patient sub-populations, characterized by race, body mass index, symptom severity, and Candida species infection.

Key Points: 
  • Ibrexafungerp demonstrated consistent efficacy in important patient sub-populations, characterized by race, body mass index, symptom severity, and Candida species infection.
  • In the pooled analysis, ibrexafungerp demonstrated statistical superiority over placebo in all efficacy endpoints.
  • The full pooled Phase 3 VANISH trial publication, titled Oral Ibrexafungerp for Vulvovaginal Candidiasis Treatment: An Analysis of VANISH 303 and VANISH 306, can be found here .
  • BREXAFEMME is a novel oral antifungal approved for the treatment of vulvovaginal candidiasis (VVC), also known as vaginal yeast infection.

SCYNEXIS Announces U.S. Food and Drug Administration Acceptance and Priority Review of the Supplemental New Drug Application for BREXAFEMME® (ibrexafungerp tablets) for Prevention of Recurrent Vaginal Yeast Infections

Retrieved on: 
Monday, August 1, 2022

The FDA granted the submission Priority Review and assigned the Prescription Drug User Fee Act (PDUFA) target decision date as November 30, 2022.

Key Points: 
  • The FDA granted the submission Priority Review and assigned the Prescription Drug User Fee Act (PDUFA) target decision date as November 30, 2022.
  • Ibrexafungerp is designated by the FDA as a qualified infectious disease product (QIDP), allowing for a six-month priority review.
  • BREXAFEMME is a novel oral antifungal approved for the treatment of vulvovaginal candidiasis (VVC), also known as vaginal yeast infection.
  • All forward-looking statements contained in this press release speak only as of the date on which they were made.

SCYNEXIS Announces Submission of Supplemental New Drug Application of BREXAFEMME® (ibrexafungerp tablets) to the U.S. Food and Drug Administration for an Expanded Indication for the Prevention of Recurrent Vaginal Yeast Infections

Retrieved on: 
Wednesday, June 8, 2022

If approved, BREXAFEMME would be the first and only oral non-azole treatment for the prevention of recurrent vaginal yeast infections.

Key Points: 
  • If approved, BREXAFEMME would be the first and only oral non-azole treatment for the prevention of recurrent vaginal yeast infections.
  • In the Phase 3 CANDLE study in RVVC, ibrexafungerp was generally safe and well-tolerated with findings consistent with the existing BREXAFEMME label.
  • As the only non-azole oral therapy available for VVC, BREXAFEMME is already revolutionizing how yeast infections are treated.
  • BREXAFEMME is a novel oral antifungal approved for the treatment of vulvovaginal candidiasis (VVC), also known as vaginal yeast infection.

SCYNEXIS Presents New Interim Positive Data of Ibrexafungerp for Refractory Vulvovaginal Candidiasis from Ongoing Phase 3 FURI Study at the American College of Obstetricians and Gynecologists (ACOG) Annual Clinical & Scientific Meeting

Retrieved on: 
Tuesday, May 10, 2022

Data show that of the FURI study patients with refractory or relapsed vulvovaginal candidiasis (VVC) treated with ibrexafungerp, 71.4% had successful clinical outcomes.

Key Points: 
  • Data show that of the FURI study patients with refractory or relapsed vulvovaginal candidiasis (VVC) treated with ibrexafungerp, 71.4% had successful clinical outcomes.
  • The new interim analysis was presented during the American College of Obstetricians and Gynecologists (ACOG) Annual Clinical & Scientific Meeting held in San Diego on May 6-8, 2022.
  • We are extremely encouraged by these data showing positive outcomes in VVC patients with severe refractory or relapsed infections, said David Angulo, M.D., Chief Medical Officer of SCYNEXIS.
  • In the study, ibrexafungerp was generally safe and well-tolerated with findings consistent with the existing BREXAFEMME (ibrexafungerp tablets) label.

SCYNEXIS Secures Additional Commercial Insurance Formulary Coverage for BREXAFEMME® (ibrexafungerp tablets), Providing Access to an Estimated 93 Million Commercially-Insured Lives

Retrieved on: 
Tuesday, April 19, 2022

Because of these key attributes, we expect to see insurance coverage continue to ramp up throughout the year and anticipate increased prescription volumes.

Key Points: 
  • Because of these key attributes, we expect to see insurance coverage continue to ramp up throughout the year and anticipate increased prescription volumes.
  • We are thrilled by our progress to date as we work to achieve broad coverage to ensure all women have access to our groundbreaking product.
  • All forward-looking statements contained in this press release speak only as of the date on which they were made.
  • SCYNEXIS undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

SCYNEXIS to Participate in Upcoming April Women’s Health Medical Conferences

Retrieved on: 
Monday, April 4, 2022

BREXAFEMME is a novel oral antifungal approved for the treatment of vulvovaginal candidiasis (VVC), also known as vaginal yeast infection.

Key Points: 
  • BREXAFEMME is a novel oral antifungal approved for the treatment of vulvovaginal candidiasis (VVC), also known as vaginal yeast infection.
  • SCYNEXIS, Inc.(NASDAQ: SCYX) is a biotechnology company pioneering innovative medicines to help millions of patients worldwide overcome and prevent difficult-to-treat infections that are becoming increasingly drug-resistant.
  • SCYNEXIS scientists are developing the companys lead asset, ibrexafungerp (formerly known as SCY-078), as a broad-spectrum, systemic antifungal for multiple fungal indications in both the community and hospital settings.
  • SCYNEXIS has initiated the launch of its first commercial product in the U.S., BREXAFEMME (ibrexafungerp tablets) .

US FDA approves Jardiance® (empagliflozin) to treat adults with heart failure regardless of left ventricular ejection fraction

Retrieved on: 
Thursday, February 24, 2022

This bacterial infection has happened in women and men who take JARDIANCE, and may lead to hospitalization, multiple surgeries, and death.

Key Points: 
  • This bacterial infection has happened in women and men who take JARDIANCE, and may lead to hospitalization, multiple surgeries, and death.
  • Swelling of an uncircumcised penis may develop that makes it difficult to pull back the skin around the tip of the penis.
  • Talk to your healthcare provider about what to do if you get symptoms of a yeast infection of the vagina or penis.
  • Talk to your healthcare provider right away if you use an over-the-counter antifungal medication and your symptoms do not go away.