Candidiasis

SCYNEXIS to Present Preclinical Data on Second Generation Fungerp SCY-247 at the 34th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID)

Retrieved on: 
Tuesday, April 9, 2024

These presentations at ECCMID 2024 continue to build upon SCY-247’s positive preclinical data illustrating its unique attributes in the fight against difficult-to-treat fungal infections.

Key Points: 
  • These presentations at ECCMID 2024 continue to build upon SCY-247’s positive preclinical data illustrating its unique attributes in the fight against difficult-to-treat fungal infections.
  • Candida auris is an emerging fungal pathogen associated with nosocomial infections and considered a serious global health threat.
  • The work here utilized the National Institute of Allergy and Infectious Diseases’ (NIAID’s) suite of preclinical services for in vivo testing (Contract Nos.
  • SCY-247, a novel second-generation IV/oral triterpenoid antifungal, demonstrates in vitro activity against fungal pathogens, including azole-resistant strains of Candida and Aspergillus

North America Molecular Diagnostics Market Size, Share & Trends Analysis Report 2024-2030: Growing Prevalence of Target Diseases & Increasing External Funding for R&D Fueling Expansion - ResearchAndMarkets.com

Retrieved on: 
Tuesday, March 26, 2024

Advancements in molecular diagnostic technology enabled the early detection of numerous diseases and reduced the possibility of severe economic & social burdens.

Key Points: 
  • Advancements in molecular diagnostic technology enabled the early detection of numerous diseases and reduced the possibility of severe economic & social burdens.
  • Molecular diagnostics enable early diagnosis of cancer, genetic disorders, and infectious diseases by using PCR, sequencing, & genetic technologies.
  • In addition, the increasing incidence of diseases, such as influenza A & B, is projected to drive market growth.
  • An increase in external funding to conduct clinical studies in molecular diagnostics is anticipated to fuel the market.

Doctor's BiomeⓇ: Women's Health - Dietary Supplement Inhibited Pathogenic E. coli Bacteria and C. albicans Yeast

Retrieved on: 
Thursday, March 21, 2024

Common UTI symptoms include urge and urinary incontinence, burning sensation while urinating, cloudy urine and pelvic pain.

Key Points: 
  • Common UTI symptoms include urge and urinary incontinence, burning sensation while urinating, cloudy urine and pelvic pain.
  • "Doctor's BiomeⓇ: Women's Health, is the first successful line extension of Doctor's BiomeⓇ.
  • Dr. Howard F. Robins, Chief Medical Officer of Doctor's BiomeⓇ explained "Our focus was to develop a proprietary dietary supplement for women that can inhibit both E. coli and C.
  • To develop Women's Health dietary supplement, we used Doctor's BiomeⓇ proprietary blend of five strains of Bifidobacteria and ten strains of Lactobacilli, as well as organic cranberry powder.

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).

Napp announces authorisation of REZZAYO® (rezafungin) in Great Britain by the UK Medicines and Healthcare Products Regulatory Agency for the treatment of invasive candidiasis in adults1

Retrieved on: 
Friday, February 2, 2024

Napp Pharmaceuticals Limited, a member of the international network of Mundipharma independent associated companies, today announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has authorised rezafungin for the treatment of invasive candidiasis in adults in Great Britain (GB).1,2

Key Points: 
  • Napp Pharmaceuticals Limited, a member of the international network of Mundipharma independent associated companies, today announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has authorised rezafungin for the treatment of invasive candidiasis in adults in Great Britain (GB).1,2
    This press release features multimedia.
  • Common adverse reactions include anaemia, hypomagnesaemia, hypophosphataemia, hypotension, wheezing, vomiting, nausea, abdominal pain, constipation, erythema, and rash.
  • Increased blood alkaline phosphatase, hepatic enzymes, alanine aminotransferase, aspartate aminotransferase and blood bilirubin were also common.
  • Transient infusion-related reactions have occurred with rezafungin, characterised by flushing, sensation of warmth, nausea, and chest tightness.2
    Rezafungin may cause increased risk of phototoxicity.

Fresenius Kabi Launches Posaconazole Injection for Prevention or Treatment of Fungal Infections

Retrieved on: 
Monday, January 29, 2024

Fresenius Kabi announced today it has introduced Posaconazole Injection, a generic substitute for Noxafil®, for use in treating or preventing serious fungal infections in adults and children who have an increased chance of getting these infections due to a weakened immune system.

Key Points: 
  • Fresenius Kabi announced today it has introduced Posaconazole Injection, a generic substitute for Noxafil®, for use in treating or preventing serious fungal infections in adults and children who have an increased chance of getting these infections due to a weakened immune system.
  • Now available in the U.S., Posaconazole Injection is the newest addition to Fresenius Kabi’s portfolio of more than 30 anti-infective molecules.
  • “The introduction of Posaconazole Injection reflects Fresenius Kabi’s ongoing commitment to expanding our portfolio of affordable generic options for the treatment and/or prevention of life-threatening infections,” said John Ducker, president and CEO of Fresenius Kabi USA.
  • Fresenius Kabi has invested nearly $1 billion to expand and update its U.S. pharmaceutical production and distribution network.

Cepheid Receives Expanded FDA Clearance with CLIA Waiver for Xpert® Xpress MVP

Retrieved on: 
Thursday, January 18, 2024

SUNNYVALE, Calif., Jan. 18, 2024 /PRNewswire/ -- Cepheid announced today that it has received FDA Clearance with Clinical Laboratory Improvement Amendments (CLIA) waiver for Xpert® Xpress MVP. This multiplex vaginal panel can now be performed in near-patient settings, enabling results within 60 minutes from a single specimen for Bacterial Vaginosis (BV), Vulvovaginal Candidiasis (VVC), and Trichomoniasis (TV). This expanded claim exemplifies Cepheid's commitment to providing expanded access to women's and sexual health by making PCR testing accessible at the point of care. The test runs on Cepheid's GeneXpert Xpress instruments and has been approved for testing women fourteen years of age and older.

Key Points: 
  • SUNNYVALE, Calif., Jan. 18, 2024 /PRNewswire/ -- Cepheid announced today that it has received FDA Clearance with Clinical Laboratory Improvement Amendments (CLIA) waiver for Xpert® Xpress MVP.
  • This expanded claim exemplifies Cepheid's commitment to providing expanded access to women's and sexual health by making PCR testing accessible at the point of care.
  • The test runs on Cepheid's GeneXpert Xpress instruments and has been approved for testing women fourteen years of age and older.
  • For more information about Cepheid's Xpert Xpress MVP test, please visit Cepheid's website.

T2 Biosystems Announces FDA 510(k) Submission to Expand Use of the FDA-Cleared T2Candida Panel to Include Pediatric Testing

Retrieved on: 
Wednesday, January 3, 2024

The T2Candida Panel is the only FDA-cleared diagnostic test able to detect sepsis-causing Candida pathogens directly from blood, in just 3-5 hours, without the need to wait days for a positive blood culture.

Key Points: 
  • The T2Candida Panel is the only FDA-cleared diagnostic test able to detect sepsis-causing Candida pathogens directly from blood, in just 3-5 hours, without the need to wait days for a positive blood culture.
  • The T2Candida Panel runs on the FDA-cleared T2Dx® Instrument and simultaneously detects five Candida species – including Candida albicans, Candida tropicalis, Candida parapsilosis, Candida krusei, and Candida glabrata.
  • The study also found a higher detection rate with the T2Candida Panel as six additional probable or possible fungal bloodstream infections in pediatric patients were detected by the T2Candida Panel and missed by blood culture.
  • T2Candida was the only test recommended for individual use as a tool for the diagnosis of invasive candidiasis in at-risk children and adolescents.

Cidara Therapeutics Announces European Approval of REZZAYO® (rezafungin) for the Treatment of Invasive Candidiasis in Adults

Retrieved on: 
Friday, December 22, 2023

REZZAYO represents the first new treatment option in over 15 years for patients with invasive candidiasis.

Key Points: 
  • REZZAYO represents the first new treatment option in over 15 years for patients with invasive candidiasis.
  • Cidara is entitled to receive a milestone payment of approximately $11.14 million from Mundipharma for the European Medicines Agency (EMA) approval.
  • SAN DIEGO, Dec. 22, 2023 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX) today announced REZZAYO (rezafungin acetate) has been approved in the European Union (EU) for the treatment of invasive candidiasis in adults.
  • Cidara Therapeutics has partnered with Mundipharma, which has commercial rights to rezafungin outside the U.S. and Japan.

SCYX STOCK ALERT: Robbins LLP Reminds Investors of the Upcoming Lead Plaintiff Deadline in the Class Action Against Scynexis, Inc.

Retrieved on: 
Saturday, December 16, 2023

Scynexis is a biotechnology company that is primarily engaged in the development of ibrexafungerp, a broad-spectrum, intravenous (IV)/oral agent for fungal indications.

Key Points: 
  • Scynexis is a biotechnology company that is primarily engaged in the development of ibrexafungerp, a broad-spectrum, intravenous (IV)/oral agent for fungal indications.
  • For more information, submit a form , email Aaron Dumas, Jr., or give us a call at (800) 350-6003.
  • What Now: Similarly situated shareholders may be eligible to participate in the class action against Scynexis, Inc. Shareholders who want to act as lead plaintiff for the class should contact Robbins LLP.
  • A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.