Mycosis

Matinas BioPharma Provides Business Update and 2023 Strategic Outlook

Retrieved on: 
Monday, January 30, 2023
Transfer, Biomedical Advanced Research and Development Authority, RNA, Necessity and sufficiency, Disease, Lipofectamine, Food, Phase II, Safety, Oligonucleotide, Mycosis, Attention, HeLa, Mucormycosis, NYSE, BioNTech, Gene expression, Evaluation, Mucor, Sirna, Vaccine, ASO, Cryptococcosis, Aspergillosis, Survival, Therapy, Conference, Gilead, BARDA, Internal, COVID, HEK293, Patient, Enactment, Clinical trial, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, FDA, Aspergillus, LNC, Organic acid, Hand, Candidiasis, Genentech, Coccidioidomycosis, Medicine, Asos, Development, RNA transfection, Sirna Therapeutics, Toxicity, Fine chemical, Pharmaceutical industry, Matina Brothers

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Key Points: 
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    BEDMINSTER, N.J., Jan. 30, 2023 (GLOBE NEWSWIRE) -- Matinas BioPharma (NYSE AMER: MTNB, Matinas), a clinical-stage biopharmaceutical company focused on redefining the intracellular delivery of nucleic acids and small molecules with its lipid nanocrystal (LNC) platform technology, today is providing a business update on its ongoing programs and discussing its strategic outlook for 2023.
  • Our ongoing collaborations with BioNTech and, recently, National Resilience, have aligned Matinas with two of the world’s leading companies in the gene therapy space.
  • The Company will host a live conference call and webcast to discuss this corporate update and 2023 business outlook today, Monday, January 30 at 4:30 p.m.
  • The live webcast will be accessible on the Investors section of Matinas BioPharma’s website, www.matinasbiopharma.com , and archived for 90 days.

EMUAID® Debuts Next Level Foot Care with Ionic Silver Socks

Retrieved on: 
Monday, January 9, 2023
Argentum, Burns, Infection, Pain, Bacteria, Colloid, Skin, Heel, Inflammation, Multimedia, Foot, Irritation, Mycosis, Growth, Laboratory, Blister, Peripheral neuropathy, Shoemaking, Petroleum jelly

EMUAID® is taking a step forward with its innovative Ionic Silver Socks.

Key Points: 
  • EMUAID® is taking a step forward with its innovative Ionic Silver Socks.
  • The new EMUAID® Ionic Silver Socks are woven with natural, broad-spectrum silver fiber for long-lasting moisture and odor control, keeping feet dry, bacteria-free, and fungus-free.
  • Whether treating a fungal condition, suffering from corns, calluses, blisters, cracked heels, neuropathy, foot pain, or preventing smelly feet, the EMUAID® Ionic Silver Socks deliver multiple functional benefits in comfortable-to-wear everyday socks.
  • Now available for purchase directly on EMUAID's website, the Ionic Silver Socks are unisex, no-show, and available in two sizes.

F2G to Present at Biotech Showcase™ 2023

Retrieved on: 
Thursday, January 5, 2023
Mycosis, Patient, PDUFA, NDA, Food, Biotechnology, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Pharmaceutical industry

MANCHESTER, United Kingdom, Jan. 05, 2023 (GLOBE NEWSWIRE) -- F2G Ltd. today announced that the Company’s chief executive officer, Francesco Lavino will provide a corporate overview at Biotech Showcase™ 2023 taking place in San Francisco, California, from January 9-11, 2023.

Key Points: 
  • MANCHESTER, United Kingdom, Jan. 05, 2023 (GLOBE NEWSWIRE) -- F2G Ltd. today announced that the Company’s chief executive officer, Francesco Lavino will provide a corporate overview at Biotech Showcase™ 2023 taking place in San Francisco, California, from January 9-11, 2023.
  • Francesco Maria Lavino will discuss the Company’s lead antifungal drug candidate, olorofim, a first-in-class, oral small molecule with a novel, differentiated mechanism of action for the treatment of invasive fungal infections.
  • Last month, the U.S. Food and Drug Administration (FDA) accepted for filing a New Drug Application (NDA) for olorofim for the treatment of invasive fungal infections in patients who have limited or no treatment options with a PDUFA date set for June 17, 2023.
  • Details for the presentation are as follows:

Basilea announces regulatory approval of antifungal Cresemba® (isavuconazole) in Japan

Retrieved on: 
Sunday, January 22, 2023
Aspergillosis, Mucormycosis, Ministry, Ministry of Health, Labour and Welfare, AKP, Cryptococcosis, Ministry of Health (Saudi Arabia), Mycosis, Growth, Patient, World Health Organization, MHLW, Pharmaceutical industry, Isavuconazonium, EU, Health

Japanese regulatory authority granted marketing authorization to Basilea’s license partner, Asahi Kasei Pharma

Key Points: 
  • Japanese regulatory authority granted marketing authorization to Basilea’s license partner, Asahi Kasei Pharma
    Intravenous and oral use of Cresemba approved for the treatment of adult patients with aspergillosis, mucormycosis, and cryptococcosis
    Basilea Pharmaceutica Ltd (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today that its license partner Asahi Kasei Pharma (“AKP”), has received the marketing authorization from the Ministry of Health, Labour and Welfare (MHLW) in Japan for Cresemba® (isavuconazole) for the treatment of adult patients with aspergillosis, mucormycosis, and cryptococcosis.
  • Aspergillosis and cryptococcosis were recently listed by the World Health Organization as most critical fungal infections that pose a major health risk.1
    David Veitch, Basilea’s CEO, stated: “We congratulate our partner AKP on the approval of Cresemba in Japan, which is an important commercial market for newer antifungals.
  • We look forward to continue working together with AKP to make Cresemba available to patients for whom invasive fungal infections can pose a serious threat.”
    Cresemba is approved in 69 countries to date and is currently marketed in 59 countries, including the United States, China, most EU member states and additional countries inside and outside of Europe.
  • In the twelve months between July 2021 and June 2022, total global in-market sales of Cresemba amounted to USD 352 million, a 24 percent growth year-on-year.2

F2G Announces FDA Filing Acceptance of New Drug Application for Olorofim for the Treatment of Invasive Fungal Infections

Retrieved on: 
Monday, December 19, 2022
Fungus, Disease, PDUFA, Scopulariopsis, Food, Mycosis, MD, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Antibiotic, File, NDA, DHODH, Patient, Mortality, Aspergillosis, Prescription Drug User Fee Act, FDA, Breakthrough therapy, Coccidioides, New Drug Application, Pharmaceutical industry, F2G

F2G has requested approval of the NDA under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD pathway) for a limited, well-defined population with invasive fungal infections and limited or no treatment options.

Key Points: 
  • F2G has requested approval of the NDA under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD pathway) for a limited, well-defined population with invasive fungal infections and limited or no treatment options.
  • Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of June 17, 2023.
  • “Invasive fungal infections cause substantial morbidity and mortality, particularly among immunosuppressed patients, and can prove to be lethal in also healthy individuals when they get into deeper tissues.
  • If approved, olorofim will be the first of a new class of antifungal drugs.”
    Olorofim is the only antifungal medication to be awarded Breakthrough Therapy Designation by the FDA.

Innovation Pharmaceuticals Reports New In Vivo Antifungal Data Showing Brilacidin’s Potential for Treating Fungal Keratitis

Retrieved on: 
Tuesday, December 13, 2022
Eye, Publishing, Posaconazole, Cryptococcus, Mycosis, Voriconazole, Cryptococcosis, Keratitis, Antifungal, Human, Orphan drug, Patient, Toxicity, Mucorales, OTCQB, Research, Mycology, Disease, Fungal keratitis, Caspofungin, University, WHO, Policy, Cornea, World Health Organization, USP, Cryptococcus neoformans, Pharmaceutical industry, Fusarium, Aspergillus

WAKEFIELD, MA, Dec. 13, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire – Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today provided an update on ongoing research on the broad-spectrum antifungal activity of Brilacidin, the Company’s defensin mimetic drug candidate exhibiting antimicrobial and immunomodulatory properties.

Key Points: 
  • New in vivo data in an A. fumigatus murine fungal keratitis model showed Brilacidin reduced fungal burden and disease severity, while also improving corneal thickness compared to control.
  • Worldwide, on an annual basis, fungal keratitis affects up to 1.5 million people, of whom 75 percent may lose an eye and/or their sight.
  • These new Brilacidin findings in fungal keratitis complement an earlier in vitro and in vivo evaluation of Brilacidin as an ocular anti-infective in bacterial keratitis.
  • A broad-spectrum drug that could target both fungal and bacterial keratitis would be uniquely positioned as to its treatment profile and commercial potential.

2022 Lundquist Legends Scott Filler, MD, and Darrell Harrington, MD, to Be Honored for Their Outstanding Career Achievements

Retrieved on: 
Monday, December 5, 2022
Candida albicans, Hospital, Medicine, Ministry of Education (Malaysia), Legend, Aspergillus fumigatus, Mycosis, Virulence, Antifungal, Infection, Doctor of Philosophy, Internal medicine, UCLA, David Geffen School of Medicine at UCLA, Graduate, Fungus, VTE, Harbor–UCLA Medical Center, Research, Risk, Division, Patient

Los Angeles, California, Dec. 05, 2022 (GLOBE NEWSWIRE) -- The 19th Annual Lundquist Legends tradition continues in 2022 with the recognition of two of its most outstanding investigators: Dr. Scott Filler and Dr. Darrell Harrington.

Key Points: 
  • Los Angeles, California, Dec. 05, 2022 (GLOBE NEWSWIRE) -- The 19th Annual Lundquist Legends tradition continues in 2022 with the recognition of two of its most outstanding investigators: Dr. Scott Filler and Dr. Darrell Harrington.
  • This year’s event will take place at the Institute’s Medical Research Laboratory on the Institute campus on December 7th.
  • Fungal invasions and their host receptors—the first two of which have been identified by Dr. Filler’s lab—are key to the eventual development of fungal vaccines.
  • “Both of these trailblazers have been leaders in the field of medicine and research, and we honor their legacies of innovation and enduring commitment to science.”

Cidara Therapeutics and Melinta Therapeutics Announce Publication of Data from the Global Phase 3 Pivotal ReSTORE Trial of Rezafungin for the Treatment of Candidemia and Invasive Candidiasis in The Lancet

Retrieved on: 
Monday, November 28, 2022
Marketing, COVID-19, DFC (cipher), SAN, Mycosis, European Medicines Agency, MAA, Caspofungin, Minocycline, Food, EMA, Safety, Therapy, Physician, Patient, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Mortality, CDTX, QIDP, Drug Quality and Security Act, Priority review, File, Meropenem, Security (finance), AstraZeneca, NDA, Fungemia, Injection, Restore, New Drug Application, Respect, PDUFA, FDA, Pharmaceutical industry, Lancet, Melinta Therapeutics, EU

SAN DIEGO and PARSIPPANY, N.J., Nov. 28, 2022 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ: CDTX) and Melinta Therapeutics, LLC today announced the peer-reviewed publication of data from the completed pivotal ReSTORE Phase 3 clinical trial evaluating the efficacy and safety of its once-weekly antifungal candidate rezafungin as a potential treatment for candidemia and invasive candidiasis. The data, published in The Lancet titled, “Rezafungin versus caspofungin for treatment of candidaemia and invasive candidiasis (ReSTORE): a multicentre, double-blind, double-dummy, randomised phase 3 trial,” demonstrate the statistical noninferiority of rezafungin dosed once-weekly, versus the current standard of care caspofungin, dosed once-daily.

Key Points: 
  • We believe that rezafungin could have a significant impact on the lives of patients battling difficult-to-treat and often deadly Candida infections.
  • Melinta announced earlier this year that it had acquired the exclusive rights to commercialize rezafungin in the U.S. from Cidara.
  • The FDA has accepted for filing and granted Priority Review to Cidaras NDA for rezafungin for the treatment of candidemia and invasive candidiasis.
  • Rezafungin is a novel once-weekly echinocandin being developed for both the treatment and prevention of serious fungal infections, such as candidemia and invasive candidiasis.

SCYNEXIS Applauds the Biomedical Advanced Research and Development Authority (BARDA) for Its New Priority Focus on Investment in Development of Antifungal Treatments to Fight Infections Caused by Drug-Resistant Fungal Threats

Retrieved on: 
Thursday, November 17, 2022
Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Tablet, Shanda, Mycosis, European Medicines Agency, WHO, Public health, Auris, Infection, Food, Biomedical Advanced Research and Development Authority, IC, EMA, IA, Biotechnology, BAA, Candida auris, Patient, QIDP, Candidiasis, Broad Agency Announcement, Aspergillus fumigatus, FURI, World Health Organization, Mucorales, News, BID, Fungemia, Fungus, Development, CBRN, Canker, IV, Drug of last resort, New Drug Application, MCM, PDUFA, FDA, Antibiotics, Pharmaceutical industry

For the first time, BARDA announced this week it is seeking partnerships to develop broad-spectrum next-generation antifungal drugs to treat high-priority fungal infections.

Key Points: 
  • For the first time, BARDA announced this week it is seeking partnerships to develop broad-spectrum next-generation antifungal drugs to treat high-priority fungal infections.
  • It is extremely exciting to see BARDA announce increased emphasis on fighting dangerous fungal pathogens, said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS.
  • Ibrexafungerp, with its promising activity against multiple drug resistant and often-deadly fungal infections, has enormous potential to benefit patients with severe fungal disease and limited treatment options.
  • In addition, late-stage clinical investigation of oral ibrexafungerp for the treatment of life-threatening invasive fungal infections in hospitalized patients is ongoing.

Napp announces acceptance of their Rezafungin Marketing Authorisation Application for the Treatment of Invasive Candidiasis to the UK Medicines and Healthcare Products Regulatory Agency

Retrieved on: 
Wednesday, November 16, 2022
Health, Infectious Diseases, Hospitals, Clinical Trials, Pharmaceutical, Biotechnology, Caspofungin, Auris, Priority review, Cambridge Science Park, Candidiasis, Multimedia, CB4, Pivotal, European Medicines Agency, Safety, Disease, QIDP, Treatment, Hospital, MAA, New Drug Application, Integrity, MHRA, NDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Mortality, Community, Hope, Jean-Louis Vincent, EMA, FDA, European Commission, Therapy, NAPP, McNeil Consumer Healthcare, Fluconazole, The New England Journal of Medicine, Food, US Foods, Medicine, Mycosis, Heart, Pain management, Food and Drug Administration, Patient, Pharmaceutical industry, Medical imaging, Hospitality industry, EU, Restore, Fungemia, Napp, Mundipharma

Napp today announces that the MHRA has accepted a marketing authorisation application for rezafungin, a novel echinocandin in clinical development for the treatment of invasive candidiasis in adult patients.

Key Points: 
  • Napp today announces that the MHRA has accepted a marketing authorisation application for rezafungin, a novel echinocandin in clinical development for the treatment of invasive candidiasis in adult patients.
  • This trial provides evidence of efficacy and the safety profile of rezafungin as a potential treatment for candidemia and invasive candidiasis with a once-weekly dosing schedule.1
    This press release features multimedia.
  • In the ReSTORE trial, rezafungin met the primary endpoint for the European Medicines Agency (EMA) marketing authorisation application of global cure at Day 14.
  • 9 Cidara Therapeutics and Mundipharma Announce Positive Topline Results from the Global Phase 3 Pivotal ReSTORE Trial of Rezafungin for the Treatment of Candidemia and Invasive Candidiasis.