Candida glabrata

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
Antimalarial medication, Polyene, Fungal infection, Candidiasis, Congress, Biotechnology, Azole, Candida auris, Patient, Mouse, Infection, University, NOS, Echinocandin, University of Texas System, Fluconazole, ECCMID, European, Candida glabrata, Pharmaceutical industry

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

Fort Worth Diagnostics (FWDX) Announces Primer Sets for Bacterial and Fungal Digital Pcr and Real-time Pcr Assays

Retrieved on: 
Thursday, February 8, 2024
Gardnerella vaginalis, Candida glabrata, Candida krusei, FDA, Research and development, Fannyhessea vaginae, CGMP, Development, ASR, CAL, PCR, FAM

FORT WORTH, Texas, Feb. 8, 2024 /PRNewswire/ -- Fort Worth Diagnostics (FWDX) announces primer sets for bacterial and fungal digital PCR and real-time PCR assays.

Key Points: 
  • FORT WORTH, Texas, Feb. 8, 2024 /PRNewswire/ -- Fort Worth Diagnostics (FWDX) announces primer sets for bacterial and fungal digital PCR and real-time PCR assays.
  • FWDX utilizes digital PCR to establish the assays and ensure reproducibility, while manufacturing the highest quality materials for real-time and digital PCR.
  • "We are proud to bring the first commercial molecular analyte specific reagents (ASR) for these bacterial and fungal targets" said Jerry Boonyaratanakornkit, Head of Research and Development, Fort Worth Diagnostics.
  • Contact Fort Worth Diagnostics for further information or visit the Fort Worth Diagnostics 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
Candida tropicalis, Food, FDA, Candidiasis, Disease, Mortality, Blood, Candida glabrata, Candida krusei, Bambino, Candida albicans, Candida parapsilosis, Patient, Diagnosis, Journal, Blood culture

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.

T2 Biosystems Receives FDA Breakthrough Device Designation for Candida Auris Diagnostic Test

Retrieved on: 
Thursday, July 20, 2023
Canker, Candida tropicalis, Fungal infection, Candida albicans, CDC, Candida auris, Therapy, Instrument, Candida krusei, Patient, Blood, Candida glabrata, Candida parapsilosis, Mortality, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Auris, Pharmaceutical industry

LEXINGTON, Mass., July 20, 2023 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, announced today the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for the Company’s Candida auris (C. auris) direct-from-blood molecular diagnostic test.

Key Points: 
  • LEXINGTON, Mass., July 20, 2023 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, announced today the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for the Company’s Candida auris (C. auris) direct-from-blood molecular diagnostic test.
  • This marks the third T2 Biosystems’ product to receive FDA Breakthrough Device designation, as the Company was previously granted FDA Breakthrough Device designation for its T2Resistance® Panel and T2Lyme™ Panel.
  • "We are pleased with the FDA’s decision to grant Breakthrough Device designation for our Candida auris test, which provides greater and more frequent access to the FDA and may accelerate our path to FDA clearance,” stated John Sperzel, Chairman and CEO of T2 Biosystems.
  • The T2Candida Panel runs on the fully-automated T2Dx Instrument and simultaneously detects five Candida species, including Candida albicans, Candida tropicalis, Candida parapsilosis, Candida krusei, and Candida glabrata.

T2 Biosystems Announces Submission for FDA Breakthrough Device Designation for Candida Auris Diagnostic Test

Retrieved on: 
Monday, June 5, 2023
Canker, De novo, Candida tropicalis, Public, Infection, Fungal infection, World Health Organization, Candida albicans, CDC, Candida auris, Candida krusei, PMA, Patient, Korea Disease Control and Prevention Agency, Candida glabrata, Candida parapsilosis, Diagnosis, Mortality, BioSystems, WHO, FDA, Food, Auris, Pharmaceutical industry, Vaccine, Medical device

LEXINGTON, Mass., June 05, 2023 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced that it has submitted an application with the U.S. Food and Drug Administration (FDA) for Breakthrough Device Designation for the Company’s Candida auris test.

Key Points: 
  • LEXINGTON, Mass., June 05, 2023 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced that it has submitted an application with the U.S. Food and Drug Administration (FDA) for Breakthrough Device Designation for the Company’s Candida auris test.
  • "We are pursuing FDA Breakthrough Device Designation for our novel direct-from-blood C. auris diagnostic test to potentially accelerate the path toward FDA clearance and commercialization,” stated John Sperzel, Chairman and CEO of T2 Biosystems.
  • The T2Candida Panel runs on the fully automated T2Dx® Instrument and simultaneously detects five Candida species, including Candida albicans, Candida tropicalis, Candida parapsilosis, Candida krusei, and Candida glabrata.
  • Rapid detection of these pathogens, as well as Candida auris, is essential to getting infected patients on appropriate antimicrobial therapy and improving clinical outcomes.

T2 Biosystems Affirms Plans to Add Candida Auris Detection to the FDA-Cleared T2Candida Panel

Retrieved on: 
Thursday, March 23, 2023
Canker, CE, Candida tropicalis, The Wall Street Journal, Public, Auris, Fungal infection, Candida albicans, CDC, Candida auris, Candida krusei, Patient, Risk, Korea Disease Control and Prevention Agency, Candida glabrata, Candida parapsilosis, Diagnosis, Mortality, FDA, World Health Organization, Vaccine

LEXINGTON, Mass., March 23, 2023 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today affirmed plans to add detection of the fungal pathogen Candida auris to the Company’s FDA-cleared and CE marked T2Candida® Panel.

Key Points: 
  • LEXINGTON, Mass., March 23, 2023 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today affirmed plans to add detection of the fungal pathogen Candida auris to the Company’s FDA-cleared and CE marked T2Candida® Panel.
  • "With prior support from the CDC, we have completed feasibility and early development of a diagnostic test to detect the Candida auris pathogen directly-from-blood and we plan to add this test to our FDA-cleared T2Candida Panel,” stated John Sperzel, Chairman and CEO of T2 Biosystems.
  • The T2Candida Panel runs on the fully-automated T2Dx® Instrument and simultaneously detects five Candida species, including Candida albicans, Candida tropicalis, Candida parapsilosis, Candida krusei, and Candida glabrata.
  • Rapid detection of these pathogens, as well as Candida auris, is essential to getting infected patients on appropriate antimicrobial therapy and improving clinical outcomes.

SCYNEXIS Presents Positive Interim Data of Oral Ibrexafungerp for Severe Fungal Infections from Ongoing Phase 3 FURI Study During IDWeek 2022

Retrieved on: 
Monday, October 24, 2022
European Medicines Agency, Candida glabrata, PDUFA, Fungus, Birth, Shanda, IA, Nausea, Population, Diagnosis, New Drug Application, EMA, Infection, QIDP, Candidiasis, NASDAQ, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Patient, Biotechnology, Diarrhea, IV, Abdominal pain, Chronic mucocutaneous candidiasis, IC, Salvage therapy, Most, Mortality, FURI, Food, VVC, Vomiting, Medical Affairs Bureau, Administration, Pipeline, Incidence, Fungemia, Mycosis, Survival, GLOBE, Canker, Death, FDA, Drug of last resort, Tablet, Pregnancy, ID, CYP3A, Dizziness, Poster, Pharmaceutical industry, Dietary supplement

All-cause mortality analysis shows 94.6% survival 30 days post-therapy in patients with invasive candidiasis or candidemia who were treated with ibrexafungerp.

Key Points: 
  • All-cause mortality analysis shows 94.6% survival 30 days post-therapy in patients with invasive candidiasis or candidemia who were treated with ibrexafungerp.
  • The analyses were presented during IDWeek 2022 held in Washington, D.C., October 19-23, 2022.
  • The data presented includes 113 patients enrolled in the FURI study who had completed treatment through October 2021.
  • In addition, late-stage clinical investigation of oral ibrexafungerp for the treatment of life-threatening invasive fungal infections in hospitalized patients is ongoing.

BREXAFEMME® (ibrexafungerp tablets) Added to Major National Formulary, Providing Access for Millions More Commercially Insured Patients

Retrieved on: 
Monday, December 20, 2021
Candidiasis, Tablet, Vaginal yeast infection, Anxiety, Birth, U.S. Securities and Exchange Commission, Food, FDA, NDA, Insurance, Pain, Embarrassment, Physician, New Drug Application, Administration, Compte rendu, Vaginitis, Candida albicans, Private Securities Litigation Reform Act, CYP3A, Incidence, Woman, Annual report, NASDAQ, Dizziness, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Biotechnology, Pregnancy, Patient, Most, Nausea, Security (finance), Infection, Vomiting, Risk, CQD, GLOBE, Candida glabrata, Depression, Diarrhea, Abdominal pain, Health insurance, Dietary supplement, Birth control, Pharmaceutical industry, VVC

We are extremely pleased to achieve such a significant level of reimbursement coverage, representing nearly half of commercially insured patients, so early in the launch of BREXAFEMME, said Christine Coyne, Chief Commercial Officer of SCYNEXIS.

Key Points: 
  • We are extremely pleased to achieve such a significant level of reimbursement coverage, representing nearly half of commercially insured patients, so early in the launch of BREXAFEMME, said Christine Coyne, Chief Commercial Officer of SCYNEXIS.
  • This formulary coverage allows appropriate patients to more easily access BREXAFEMME and reinforces recognition by payers of the unmet need that BREXAFEMME is filling for patients with VVC.
  • BREXAFEMME is a novel first-in-class fungicidal triterpenoid antifungal, designed to kill the yeast causing the infection, including azole-resistant strains.
  • All forward-looking statements contained in this press release speak only as of the date on which they were made.

SCYNEXIS Pivotal Phase 3 VANISH-303 Trial Results Published in Clinical Infectious Diseases Demonstrate Significant Superiority of Ibrexafungerp Over Placebo for Treatment of Vaginal Yeast Infection

Retrieved on: 
Thursday, October 21, 2021
Safety, Woman, CQD, Infection, Fungus, Depression, Pregnancy, CYP3A, Research, Biotechnology, Body mass index, Most, Abdominal pain, Tablet, Dizziness, Vaginal yeast infection, Anxiety, Candidiasis, New Drug Application, Patient, Birth, NASDAQ, FDA, Candida albicans, Food, Nausea, Administration, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Nature, VSS, Embarrassment, Vomiting, Vaginitis, Candida glabrata, Diarrhea, NDA, Pain, GLOBE, Fluconazole, Incidence, Infectious Diseases Society of America, Dietary supplement, Pharmaceutical industry, Birth control, Risk management

In the Phase 3 VANISH-303 study, ibrexafungerp demonstrated significantly higher rates of clinical cure and infection eradication versus placebo.

Key Points: 
  • In the Phase 3 VANISH-303 study, ibrexafungerp demonstrated significantly higher rates of clinical cure and infection eradication versus placebo.
  • Ibrexafungerp versus placebo for vulvovaginal candidiasis treatment: a Phase 3, randomized, controlled superiority trial (VANISH-303) The randomized, double-blind, placebo-controlled study evaluated the efficacy and safety of oral ibrexafungerp for the treatment of VVC, also known as vaginal yeast infection.
  • Symptom resolution was sustained and further increased with ibrexafungerp compared with placebo (59.6% [112/188] vs 44.9% [44/98]; P=0.009) at follow-up.
  • Vulvovaginal Candidiasis (VVC), commonly known as a vaginal yeast infection due to Candida, is the second most common cause of vaginitis.

SCYNEXIS to Present Pooled Data Analysis Results Demonstrating Consistent Efficacy and Safety Outcomes Across Two Phase 3 VANISH Clinical Trials of Oral Ibrexafungerp Therapy for Vaginal Yeast Infection at October Medical Conferences

Retrieved on: 
Wednesday, October 13, 2021
CQD, Most, Candida glabrata, Food, Vaginitis, Incidence, Vagina, International Society for Infectious Diseases, Administration, Candidiasis, Dizziness, Drug of last resort, CYP3A, Congress, Embarrassment, Women's health nurse practitioner, Nurse practitioner, Pain, Depression, International Society, NDA, Safety, Infection, Oral, Tablet, Woman, Abdominal pain, New Drug Application, Birth, Conference, Nausea, Diarrhea, FDA, Patient, Vaginal yeast infection, Pregnancy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, GLOBE, Biotechnology, ISIDOG, Vomiting, Medical Affairs Bureau, Anxiety, NASDAQ, Candida albicans, Pharmaceutical industry, Birth control, Dietary supplement

We are deeply committed to innovation in the field of womens health and are extremely pleased to be able to share this additional pooled data analysis from our groundbreaking VANISH clinical research.

Key Points: 
  • We are deeply committed to innovation in the field of womens health and are extremely pleased to be able to share this additional pooled data analysis from our groundbreaking VANISH clinical research.
  • 24th Annual NPWH Premier Womens Healthcare Conference, October 13-16, 2021
    Title: BREXAFEMME (ibrexafungerp tablets) A Novel, Oral Treatment for Vulvovaginal Candidiasis
    Title: Efficacy and Safety of Oral Ibrexafungerp in Subjects with Vulvovaginal Candidiasis: Pooled Data from Two Phase 3, Randomized, Blinded, Study vs.
  • Meeting attendees can view the conference sessions and posters on demand until January 12, 2022.
  • In addition, late-stage clinical investigation of ibrexafungerp for the prevention of recurrent vulvovaginal candidiasis (rVVC) and the treatment of life-threatening invasive fungal infections in hospitalized patients is ongoing.