Azole

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

Three Patients with Invasive Fusarium Infection in Matinas BioPharma’s Oral MAT2203 Compassionate/Expanded Use Access Program Achieve Complete Clinical Response

Retrieved on: 
Friday, March 22, 2024
Nephrotoxicity, Urinary tract infection, Fungal infection, Culture, Ventilator-associated pneumonia, Burns, Internal medicine, Amphotericin B, Emphysema, Azole, Coronary artery disease, Debridement, Carcinoma, Risk, Hyperlipidemia, Patient, Lung, LNC, Fusarium, Female, Malignancy, University, Doctor of Philosophy, MD, Aspergillosis, Echinocandin, Fever, Immune system, Division, Hypertension, Voriconazole, Physician, Infection, Pharmaceutical industry

The successful MAT2203 treatment outcome in these patients therefore adds to our confidence for the upcoming ORALTO Phase 3 trial in patients suffering from invasive aspergillosis with limited treatment options.

Key Points: 
  • The successful MAT2203 treatment outcome in these patients therefore adds to our confidence for the upcoming ORALTO Phase 3 trial in patients suffering from invasive aspergillosis with limited treatment options.
  • She was transitioned to oral MAT2203 for two weeks, which led to clinical resolution of her fungal infection.
  • She began to show clinical improvement following two weeks of oral MAT2203 treatment and her skin wounds completely healed following six months of MAT2203 treatment.
  • “MAT2203 continues to demonstrate its potential to effectively treat invasive fungal infections and help patients achieve complete clinical resolution.

FDA Grants Orphan Drug and Pediatric Exclusivities for CRESEMBA® (isavuconazonium sulfate) for Invasive Aspergillosis and Invasive Mucormycosis in Children

Retrieved on: 
Monday, March 11, 2024
Astellas Pharma, Capsule, New Drug Application, Patient, IM, Research, Infection, Azole, Marketing, FDA, Food, Pharmaceutical industry

NORTHBROOK, Ill., March 11, 2024 /PRNewswire/ -- Astellas Pharma US, Inc.  (TSE: 4503, President: Mark Reisenauer, "Astellas") announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug and pediatric exclusivity to CRESEMBA® (isavuconazonium sulfate) for the treatment of invasive aspergillosis (IA) and invasive mucormycosis (IM) in pediatric patients. On December 8, 2023, CRESEMBA for injection was approved for pediatric patients 1 year of age and older and capsules for pediatric patients 6 years of age and older who weigh 16 kilograms (kg) and greater.  

Key Points: 
  • On December 8, 2023, CRESEMBA for injection was approved for pediatric patients 1 year of age and older and capsules for pediatric patients 6 years of age and older who weigh 16 kilograms (kg) and greater.
  • The FDA grants orphan drug exclusivity to orphan drugs that receive FDA marketing approval.
  • The FDA previously granted orphan drug exclusivity for CRESEMBA in 2015 for the treatment of IA and IM in adults.
  • "Astellas recognizes the importance of addressing significant unmet medical needs, especially for pediatric patients with rare and potentially life-threatening IA and IM infections.

Matinas BioPharma Provides Positive Outcomes Update on the MAT2203 Compassionate/Expanded Use Access Program, Including Multiple Patients with Complete Clinical Resolution

Retrieved on: 
Monday, February 26, 2024
Infection, Bangladesh Technical Education Board, Division, Amphotericin B, Palliative care, Recurrence, University, Doctor of Philosophy, Malignancy, Nationwide, Physician, City, Azole, Hospital, Cryptococcosis, Nephrotoxicity, Skin, Aspergillosis, Fusarium, Lung, Fungal infection, Johns Hopkins, Vanderbilt University Medical Center, LNC, Coccidioides, Patient, Coccidioidomycosis, Histoplasmosis, Brain, Pharmaceutical industry

BEDMINSTER, N.J., Feb. 26, 2024 (GLOBE NEWSWIRE) -- Matinas BioPharma (NYSE American: MTNB), a clinical-stage biopharmaceutical company focused on delivering groundbreaking therapies using its lipid nanocrystal (LNC) platform delivery technology, today provided an update from its ongoing Compassionate/Expanded Use Access Program (the “Program”) with MAT2203, the Company’s proprietary, LNC-delivered oral formulation of the broad-spectrum antifungal drug amphotericin B.

Key Points: 
  • Treatment with MAT2203 was well tolerated and led to favorable clinical and radiological response and we did not observe any renal toxicity.
  • 5 additional patients have shown objective improvement in clinical markers and are continuing treatment with MAT2203 as planned.
  • 2 patients transitioned to palliative care shortly after starting therapy with MAT2203 because of unanticipated progression of their malignant disease.
  • “We continue to be excited about the ongoing, consistent positive clinical impact of MAT2203, seen in these extremely ill patients,” said Theresa Matkovits, PhD, Chief Development Officer at Matinas .

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
Partnership, Oteseconazole, Vaginal discharge, Red, Candidiasis, Capsule, Irritation, CYP, Fluconazole, Yeast, Patient, National Medical Products Administration, Azole, Enzyme, FDA, Candida albicans, Excipient, Dyspareunia, Vaginal yeast infection, Hypersensitivity, Combustion, Fissure, CYP51, Woman, Pharmaceutical industry

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).

FDA Approves Expanded Use of CRESEMBA® (isavuconazonium sulfate) in Children with Invasive Aspergillosis and Invasive Mucormycosis

Retrieved on: 
Friday, December 8, 2023
Disease, Capsule, Immunodeficiency, Single-use medical devices, Safety, Food, Risk, Patient, Medical Mycology, FDA, Trial of the century, Pharmacokinetics, Azole, COVID-19, Bone marrow, TIMM, Pharmaceutical industry, IM, Astellas Pharma

NORTHBROOK, Ill., Dec. 8, 2023 /PRNewswire/ -- Astellas Pharma US, Inc. (President: Mark Reisenauer, "Astellas") today announced that the U.S. Food and Drug Administration (FDA) has approved CRESEMBA® (isavuconazonium sulfate), an azole antifungal drug, for the treatment of invasive aspergillosis (IA) and invasive mucormycosis (IM) in pediatric patients. CRESEMBA for injection is approved for adults and now for pediatric patients 1 year of age and older. CRESEMBA capsules are approved for adults and now for pediatric patients 6 years of age and older who weigh 16 kilograms (kg) and greater. With this approval, CRESEMBA is now the only azole antifungal therapy approved for the treatment of IA and IM in patients as young as one.

Key Points: 
  • CRESEMBA for injection is approved for adults and now for pediatric patients 1 year of age and older.
  • CRESEMBA capsules are approved for adults and now for pediatric patients 6 years of age and older who weigh 16 kilograms (kg) and greater.
  • With this approval, CRESEMBA is now the only azole antifungal therapy approved for the treatment of IA and IM in patients as young as one.
  • "IA, currently the most common invasive mold infection in these patients, and IM are associated with significant morbidity and high fatality rates.

Hospital and Clinical Pharmacy Preferred Distribution Channels for Blastomycosis Drugs: Market Insights and Regional Analysis - ResearchAndMarkets.com

Retrieved on: 
Monday, August 14, 2023
General Health, Infectious Diseases, Hospitals, Health, Pharmaceutical, Infection, Fungal infection, Prevalence, Blastomycosis, Medicine, Spore, Wood, Incidence, Soil, Patient, Tuberculosis, Azole, Chrysosporium, Geography, Conditional sentence, Growth, Immunodeficiency, Pneumonia, Pharmaceutical industry

The "Blastomycosis Market by Drug Type, Distribution Channel, Formulation, and Geography: Forecast up to 2027" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Blastomycosis Market by Drug Type, Distribution Channel, Formulation, and Geography: Forecast up to 2027" report has been added to ResearchAndMarkets.com's offering.
  • This report provides a comprehensive analysis of the market for the treatment of blastomycosis, a fungal infection caused by Blastomyces dermatitidis.
  • Blastomycosis is a fungal infection caused by the organism Blastomyces dermatitidis, which grows in wood and soil.
  • The blastomycosis market is segmented based on drug type, distribution channel, formulation, and geography.

U.S. FDA Accepts Astellas' sNDA for CRESEMBA® (isavuconazonium sulfate) in Children

Retrieved on: 
Thursday, August 10, 2023
Prescription Drug User Fee Act, Head, New Drug Application, Pharmacokinetics, Research, Doctor of Philosophy, Shanda, MD, Patient, Azole, Physician, Blood, Cancer, Disease, PDUFA, Ageing, Trial of the century, Immunodeficiency, Fungal infection, FDA, Death, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Isavuconazonium, Food, Safety, Pharmaceutical industry, Astellas Pharma

NORTHBROOK, Ill., Aug. 10, 2023 /PRNewswire/ -- Astellas Pharma US, Inc. (President: Mark Reisenauer, "Astellas") announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental New Drug Application (sNDA) for CRESEMBA® (isavuconazonium sulfate), a prodrug of isavuconazole, an azole antifungal drug, seeking approval for the treatment of invasive aspergillosis (IA) or invasive mucormycosis (IM) in pediatric patients aged one to 17 years old. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of December 9, 2023.

Key Points: 
  • Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of December 9, 2023.
  • CRESEMBA is already approved by the FDA for the treatment of IA and IM in adults.
  • If approved for pediatric use, it may offer children significant advances in treatment or may provide a treatment where no adequate therapy exists.
  • "This sNDA acceptance by the FDA brings Astellas one step closer to helping pediatric patients by potentially having a new treatment option available for IA and IM for a younger patient population, if approved."

Matinas BioPharma Reports Second Quarter 2023 Financial Results and Provides a Business Update

Retrieved on: 
Wednesday, August 9, 2023
BioNTech, CT, Nephrotoxicity, IV, Diabetes, Hospital, Mucor, Conference call, Clinical trial, Women's Hospital International and Fertility Centre, Infection, Brain, LNC, Research, Biomedical Research, European Congress of Ethnic Religions, Messenger, Lung, Acute myeloid leukemia, Development, MRI, Kidney, National Resilience Institute, ECCMID, MD, Patient, Standard of care, Azole, Microsoft Access, RNA interference, Fungal infection, FDA, Nationwide, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BARDA, Conference, NYSE, Food, Female, Pharmaceutical industry, Medical imaging, Antifungal

BEDMINSTER, N.J., Aug. 09, 2023 (GLOBE NEWSWIRE) --  Matinas BioPharma (NYSE American: MTNB), a clinical-stage biopharmaceutical company focused on delivering groundbreaking therapies using its lipid nanocrystal (LNC) platform delivery technology, reports financial results for the three and six months ended June 30, 2023 and provides a business update.

Key Points: 
  • Matinas’ collaboration with National Resilience continues to focus on in vitro and in vivo delivery of mRNA and expects initial data later in 2023.
  • The Company reported no revenue for the second quarter of 2023 compared with $1.1 million of revenue for the second quarter of 2022, which was generated from the Company’s research collaborations with BioNTech SE.
  • Total costs and expenses for the second quarter of 2023 were $6.2 million compared with $7.0 million for the second quarter of 2022.
  • The net loss for the second quarter of 2023 was $6.1 million, or $0.03 per share, compared with a net loss for the second quarter of 2022 of $5.9 million, or $0.03 per share.

Endo Launches First Generic Version of Noxafil® (posaconazole) Injection

Retrieved on: 
Thursday, June 29, 2023
CLL, Hypersensitivity, Lymphocytosis, Pimozide, Arrhythmia, Tacrolimus, Chronic lymphocytic leukemia, SLL, Liver disease, Simvastatin, Magnesium, Atorvastatin, Antifungal, Person, QT, Sirolimus, QT interval, Ergot, Alkaline phosphatase, Plasma, Kidney, Lovastatin, Ergotism, Patient, Azole, Risk, Electrolyte, Ergotamine, Dihydroergotamine, Tumor lysis syndrome, Ciclosporin, ALT, Quinidine, Rhabdomyolysis, Potassium, AST, Venetoclax, Pharmaceutical industry, Posaconazole, CYP3A4

Concomitant administration of posaconazole with sirolimus increases the sirolimus blood concentrations by approximately 9-fold and can result in sirolimus toxicity.

Key Points: 
  • Concomitant administration of posaconazole with sirolimus increases the sirolimus blood concentrations by approximately 9-fold and can result in sirolimus toxicity.
  • Posaconazole may increase the plasma concentrations of ergot alkaloids (ergotamine and dihydroergotamine) which may lead to ergotism.
  • Reserve azole antifungals, including posaconazole injection, for patients receiving a vinca alkaloid, including vincristine, who have no alternative antifungal treatment options.
  • Posaconazole injection is indicated for the treatment of invasive aspergillosis in adults and pediatric patients 13 years of age and older.