Fungemia

Cidara Therapeutics Receives $11.14 Million Milestone Payment Following European Approval of REZZAYO

Retrieved on: 
Monday, February 12, 2024
SAN, European Commission, Committee, CDTX, Tavarua, Caspofungin, FDA, Standard of care, Fungemia, Civil service commission, Therapy, CHMP, Patient, DFC, IND, Immune system, CD73, Pharmaceutical industry

SAN DIEGO, Feb. 12, 2024 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced receipt of an $11.14 million milestone payment from Mundipharma following the European approval of REZZAYO™ (rezafungin acetate), a novel, once-weekly echinocandin antifungal approved for the treatment of invasive candidiasis in adults.

Key Points: 
  • SAN DIEGO, Feb. 12, 2024 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced receipt of an $11.14 million milestone payment from Mundipharma following the European approval of REZZAYO™ (rezafungin acetate), a novel, once-weekly echinocandin antifungal approved for the treatment of invasive candidiasis in adults.
  • The drug was previously approved by the United States Food and Drug Administration (FDA) for the treatment of candidemia and invasive candidiasis in patients with limited or no treatment options.
  • “The European approval of REZZAYO marks a significant milestone for patients who are in need of new treatment options for invasive candidiasis, and we look forward to seeing Mundipharma bring it to the EU market,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara.
  • Its lead oncology DFC, CBO421, is a potential best-in-class inhibitor of CD73, a validated target highly expressed on tumor cells.

T2 Biosystems Announces Participation in NIH-funded Antibacterial Resistance Leadership Group (ARLG) Pilot Study for Pneumonia Patients

Retrieved on: 
Thursday, January 18, 2024
VAP, Patient, Therapy, Infection, Pneumonia, Fungemia, Ventilator-associated pneumonia, University, Microbiology, University of Utah, COVID-19, NIH, FDA, Microbiology Spectrum, Diagnosis, Blood

LEXINGTON, Mass., Jan. 18, 2024 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced participation in the NIH-funded Antibacterial Resistance Leadership Group (ARLG) pilot study for pneumonia patients.

Key Points: 
  • LEXINGTON, Mass., Jan. 18, 2024 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced participation in the NIH-funded Antibacterial Resistance Leadership Group (ARLG) pilot study for pneumonia patients.
  • The Pneumonia Direct Pilot study is a prospective, observational, diagnostic, feasibility study to determine the accuracy of multiple pathogen- and host-directed tests for the diagnosis of ventilator-associated pneumonia (VAP).
  • “I am elated that the innovative research leaders of Antibacterial Resistance Leadership Group are collaborating with T2 Biosystems to evaluate direct-from-blood diagnostic technology for the management of patients with pneumonia.
  • The extremely low level of detection by T2 Biosystems’ technology (“T2MR”) in whole blood (1 – 11 CFU/mL) has been effective in detecting secondary infections.

Cidara Therapeutics Announces Completion of Enrollment in Phase 3 Restore Trial of Rezafungin in China

Retrieved on: 
Wednesday, December 6, 2023
Food, Caspofungin, Biotechnology, Melinta Therapeutics, EMA, Burn, European, SAN, Therapy, CDTX, European Medicines Agency, MPH, Patient, Safety, Food and Drug Administration, Fungemia, CHMP, Pharmaceutical industry

SAN DIEGO, Dec. 06, 2023 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology developing therapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced the company, along with Mundipharma, has completed enrollment in the Phase 3 ReSTORE trial in China evaluating the efficacy and safety of rezafungin as a treatment for candidemia and invasive candidiasis.

Key Points: 
  • The portion of the trial conducted in China included 52 patients diagnosed with candidemia and/or invasive candidiasis.
  • ReSTORE ( NCT03667690 ) is a global, randomized, double-blind, controlled Phase 3 pivotal clinical trial evaluating the efficacy and safety of once-weekly intravenous dosing of rezafungin compared to once-daily dosing of caspofungin, the current standard of care, to treat patients with candidemia and/or invasive candidiasis.
  • “The completion of this trial enrollment marks a significant step in our efforts to bring an important treatment option to patients living with difficult to treat candidemia and invasive candidiasis,” said Taylor Sandison, M.D., MPH, chief medical officer of Cidara.
  • Melinta Therapeutics has the exclusive commercialization rights to REZZAYOTM (rezafungin for injection) in the U.S. and Mundipharma has the commercialization rights to rezafungin in all geographies other than the U.S. and Japan.

Basilea announces acquisition of fosmanogepix, a phase-3-ready broad-spectrum antifungal

Retrieved on: 
Monday, November 13, 2023
NDA, Isavuconazonium, Pfizer, Safety, Food, US Foods, Basilea Pharmaceutica, Patient, FDA, Fungal infection, USD, CHF, FY, Candida auris, Pharmaceutical industry, Fungemia, Allschwil

In addition, Basilea has acquired the rights to a preclinical antifungal compound.

Key Points: 
  • In addition, Basilea has acquired the rights to a preclinical antifungal compound.
  • Fosmanogepix is a potential first-in-class antifungal treatment candidate with a novel mechanism of action.
  • Basilea assumes all rights and obligations from previous agreements, comprising potential development, regulatory, and commercial milestone payments of up to USD 396 million, as well as tiered single-digit royalty payments.
  • Correspondingly, the BARDA reimbursements, as well as operating expenses, will be reduced by the amount of such application fee.

Melinta Therapeutics & Cidara Therapeutics Announce Publication of Pooled Data from Phase 3 Pivotal ReSTORE Trial & Phase 2 STRIVE Trial of REZZAYO® (rezafungin for injection) for the Treatment of Candidemia & Invasive Candidiasis in The Lancet ID

Retrieved on: 
Tuesday, December 5, 2023
Other Health, Research, Managed Care, Pharmaceutical, Hospitals, Clinical Trials, Science, Surgery, Biotechnology, FDA, Other Science, Health, CDTX, Lancet, NDA, Priority review, Disease, Safety, Food, Melinta Therapeutics, European Medicines Agency, Therapy, NTAP, Injection, Randomized controlled trial, QIDP, The Lancet, MAA, Mortality, Restore, EMA, Patient, Caspofungin, CHMP, Marketing, Advanced Therapy Medicinal Product, New Drug Application, CMS, MPH, Medicare, Hospital, Pharmaceutical industry, MD, Fungemia

These findings are of clinical importance given the ongoing morbidity and mortality caused by candidemia and invasive candidiasis.

Key Points: 
  • These findings are of clinical importance given the ongoing morbidity and mortality caused by candidemia and invasive candidiasis.
  • On March 22, 2023, the FDA approved REZZAYO for the treatment of candidemia and invasive candidiasis in adults with limited or no alternative treatment options.
  • REZZAYO is the first new treatment option approved for patients with candidemia and invasive candidiasis in over fifteen years.
  • In October, the EMA Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for rezafungin (rezafungin acetate) for the treatment of invasive candidiasis in adults.

Melinta Therapeutics Announces Expanded Reimbursement and Access for REZZAYO™ (rezafungin for injection)

Retrieved on: 
Monday, October 2, 2023
Health, FDA, Hospitals, Surgery, Managed Care, Pharmaceutical, Biotechnology, Priority review, Centers for Medicare & Medicaid Services, CMS, NTAP, IV, QIDP, Food, Candidiasis, Fungemia, Medicare, Hospital, Patient, Physician, Injection, Echinocandin, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, News, Pharmaceutical industry, Health insurance, Melinta Therapeutics

Melinta Therapeutics (Melinta), a commercial-stage company providing innovative therapies for acute and life-threatening illnesses, today announced expanded reimbursement and access for REZZAYO™ (rezafungin for injection).

Key Points: 
  • Melinta Therapeutics (Melinta), a commercial-stage company providing innovative therapies for acute and life-threatening illnesses, today announced expanded reimbursement and access for REZZAYO™ (rezafungin for injection).
  • “These two important milestones will help facilitate access to this innovative treatment option in both inpatient and outpatient settings.
  • Last year, Melinta acquired the exclusive rights to commercialize REZZAYO in the U.S. from Cidara Therapeutics.
  • “This is another opportunity for Melinta to deliver on our mission to provide innovative therapies to people impacted by acute and life-threatening illnesses.”

Church & Dwight Issues National Recall of One Specific Lot of TheraBreath Strawberry Splash for Kids 16oz Sold Exclusively on Amazon Between May 31 and September 02, 2023, due to microbial contamination identified as yeast (Candida parapsilosis).

Retrieved on: 
Wednesday, September 13, 2023
Online, Fungemia, Extraction (chemistry), Completeness, Fungal infection, Universal Product Code, Infection, Lot, UPC, TheraBreath (brand), Church & Dwight, Knowledge, Candida parapsilosis, FDA, Regulation of tobacco by the U.S. Food and Drug Administration, NYSE, Food, Vaccine, Dietary supplement, Amazon

No other TheraBreath products or other lots of TheraBreath Strawberry Splash for Kids are included in this recall.

Key Points: 
  • No other TheraBreath products or other lots of TheraBreath Strawberry Splash for Kids are included in this recall.
  • The use of the affected product in immune compromised individuals could potentially result in severe or life-threatening adverse events such as fungemia or disseminated fungal infection.
  • TheraBreath Strawberry Splash for Kids is indicated as an anti-cavity mouthwash for adults and children 6 years of age and older.
  • The lot of recalled mouthwash product is listed below with the Universal Product Code (UPC) and Lot number.

Melinta Therapeutics Announces Commercial Availability of REZZAYO™ (rezafungin for injection)

Retrieved on: 
Monday, July 31, 2023
Biotechnology, Pharmaceutical, Managed Care, Surgery, Health, FDA, Hospitals, Other Health, IV, Echinocandin, Candidiasis, Priority review, Therapy, Multimedia, Melinta Therapeutics, Patient, QIDP, Physician, Fungemia, Pharmaceutical industry

Melinta Therapeutics, LLC today announced the availability of REZZAYO™ (rezafungin for injection), for the treatment of candidemia and invasive candidiasis in adults with limited or no alternative treatment options.

Key Points: 
  • Melinta Therapeutics, LLC today announced the availability of REZZAYO™ (rezafungin for injection), for the treatment of candidemia and invasive candidiasis in adults with limited or no alternative treatment options.
  • REZZAYO is the first new treatment option approved for patients with candidemia and invasive candidiasis in over a decade.
  • Based on Qualified Infectious Disease Product (QIDP) designation, REZZAYO was approved under Priority Review.
  • John Harlow, Chief Commercial Officer for Melinta Therapeutics said, “Making REZZAYO available in the U.S. is another way Melinta will leverage our expansive commercial infrastructure and experience launching products and therapies into acute care environments with the ultimate goal of better patient care and outcomes.”
    Last year, Melinta announced that it had acquired the exclusive rights to commercialize REZZAYO in the U.S. from Cidara Therapeutics.

Global Invasive Fungal Infections Market Report 2023: Increasing Invasive Fungal Infections with Life-threatening Conditions Drive Growth - ResearchAndMarkets.com

Retrieved on: 
Monday, May 29, 2023
Biotechnology, Pharmaceutical, Health, Molecule, Amphotericin B, Fungal infection, Risk factor, Imidazole, Prevalence, Diabetes, HIV, Blastomycosis, Posaconazole, Infection, Candidiasis, Overalls, Isavuconazonium, Ageing, Mucormycosis, Merck & Co., Polyene, Fungemia, CDC, Incidence, AR, Patient, Developed country, ROW, Growth, Mortality, Merck, Immunodeficiency, Immunosuppression, Cryptococcus, Pfizer, Triazole, Pharmaceutical industry, Vaccine, Voriconazole, Echinocandin, Aspergillosis, Azole, Fluconazole

However, there are also antibody molecules in early preclinical development, which are currently not on the market.

Key Points: 
  • However, there are also antibody molecules in early preclinical development, which are currently not on the market.
  • The increasing use of broad-spectrum antibiotics, the aging population, and the growing prevalence of immunocompromised patients are driving the growth of invasive candidiasis.
  • By Region: The report provides insight into the invasive fungal infections market based on the geographical operations, namely North America, Europe, Asia Pacific, and ROW.
  • The North American region has emerged as a dominant player in the invasive fungal infections market, owing to several key factors.

T2 Biosystems Highlights New Clinical Data Presented at the ECCMID 2023 Conference

Retrieved on: 
Wednesday, April 26, 2023
Hospice and palliative medicine, Fungemia, High, Motol University Hospital, Karolinska University Hospital, ECCMID, Patient, Fungal infection, Data, Blood, Poster, Blood culture, European Society of Clinical Microbiology and Infectious Diseases, Bloodstream infections, Infection, Medical imaging

LEXINGTON, Mass., April 26, 2023 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today highlighted new clinical data supporting the T2Bacteria® Panel and the T2Candida® Panel, that was recently presented at the European Society of Clinical Microbiology and Infectious Diseases (ECCMID) conference in Copenhagen, Denmark.

Key Points: 
  • LEXINGTON, Mass., April 26, 2023 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today highlighted new clinical data supporting the T2Bacteria® Panel and the T2Candida® Panel, that was recently presented at the European Society of Clinical Microbiology and Infectious Diseases (ECCMID) conference in Copenhagen, Denmark.
  • The data demonstrates the speed, accuracy and clinical benefits of the T2Dx® Instrument and T2 Biosystems’ sepsis panels.
  • Data presented at the Innovation Session analyzed the detection time of both T2Bacteria and T2 sepsis panels.
  • High Specificity and High Sensitivity: The T2 sepsis panels provided a tremendous improvement in the analytical phase of bloodstream infections detection.