Mucormycosis

Orphan designation: Fosmanogepix Treatment of mucormycosis, 15/02/2023 Positive

Retrieved on: 
Saturday, January 20, 2024
COMP, Mucormycosis, Committee, European Commission, IRIS, Patient, EMA, Pharmaceutical industry

Key facts

Key Points: 
  • Key facts
    - Active substance
    - Fosmanogepix
    - Intended use
    - Treatment of mucormycosis
    - Orphan designation status
    - Positive
    - EU designation number
    - EU/3/23/2749
    - Date of designation
    - Sponsor
    Pfizer Europe MA EEIG
    Patients' organisations
    For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
    European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
  • EU register of orphan medicines
    The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:
    EMA list of opinions on orphan medicinal product designation
    EMA publishes information on orphan medicinal product designation adopted by the Committee for Orphan Medicinal Products (COMP) on the IRIS online platform:

Basilea announces that FDA approves expanded use of antifungal Cresemba® (isavuconazole) in the United States in children with invasive aspergillosis and invasive mucormycosis

Retrieved on: 
Monday, December 11, 2023
European Commission, FDA, EMA, European, Civil service commission, Mucormycosis, Pharmacokinetics, Trial of the century, European Medicines Agency, Infection, Growth, Patient, Safety, Pharmaceutical industry

Cresemba for injection is approved for adults and now for pediatric patients 1 year of age and older.

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 and greater.
  • Dr. Marc Engelhardt, Chief Medical Officer of Basilea, said: “We congratulate Astellas on the approval of Cresemba for the use in children who suffer from invasive aspergillosis or mucormycosis.
  • In Europe, Basilea submitted a similar application for a pediatric label extension of Cresemba in August 2023.

Study Published in Science Translational Medicine Shows Exbaq’s Experimental Vaccine Protects Against Many of the Most Dangerous Antibiotic Resistant Superbugs Causing Hospital Acquired Infections

Retrieved on: 
Thursday, October 5, 2023
Patent, Partnership, Klebsiella pneumoniae, Infection, Methicillin-resistant Staphylococcus aureus, Homeland, Homeland security, Innovation, Acinetobacter baumannii, IND, Fungus, National Institute of Allergy and Infectious Diseases, Fungal infection, Hulk, Laboratory, Pseudomonas aeruginosa, Patient, FDA, Mucormycosis, R01, Macrophage, Escherichia coli, Immune system, USC, Bangladesh Technical Education Board, Vancomycin-resistant Enterococcus, ESBL, Korea Disease Control and Prevention Agency, Blood, Enterococcus, Translational medicine, Denise Spellberg, NIH, Vaccine, Pharmaceutical industry, Klebsiella, Science

Multiple studies in different laboratories have confirmed the vaccine protected against serious infections within 24 hours and lasts for up to 28 days.

Key Points: 
  • Multiple studies in different laboratories have confirmed the vaccine protected against serious infections within 24 hours and lasts for up to 28 days.
  • Early data suggest that a second dose may extend the window to prevent infection.
  • The study was published in Science and Translational Medicine.
  • These infections are often caused by highly antibiotic-resistant superbugs, many of which are targeted by this new ExBaq vaccine.

Fungal infections in the brain aren't just the stuff of movies – Africa grapples with a deadly epidemic

Retrieved on: 
Thursday, July 13, 2023
Gaps, Review, Infection, Canker, Pressure, Human, Fungal infection, HIV, Atmosphere, Culture, Health care, Pneumocystis jirovecii, Fever, Cough, Immunodeficiency, Inflammation, Cryptococcosis, Brain, Research, COVID, Mucormycosis, Fungus, Facial, Thermoregulation, Death, Climate change, The Last of Us, Soil, Patient, Population, Risk, Cryptococcus neoformans, Pneumocystidomycetes, Immune system, Lower respiratory tract infection, Steroid, Diagnosis, Flucytosine, Health, Environment, Meningitis, Cryptococcus, Pneumonia, Skin, Disease, Truffle, Pharmaceutical industry, Vaccine

I am a neurobiologist who has been studying fungal infections of the brain for 10 years.

Key Points: 
  • I am a neurobiologist who has been studying fungal infections of the brain for 10 years.
  • I was part of a team that recently published a review discussing the emergence, and re-emergence, of fungal infections in Africa, especially in sub-Saharan Africa.
  • We conclude that Africa is suffering from a silent, but costly, epidemic of fungal infections.

What are fungal infections?

    • For the greater part of the history of humankind, fungal infections were never a threat to human health.
    • Even then, our immune systems are quite capable of fighting against fungal infections.
    • Africa accounts for 67% of the global burden of HIV, and opportunistic fungal diseases are on the rise.

Some examples

    • Today, sub-Saharan Africa contributes about 73% of all global cases and deaths resulting from the disease.
    • Cryptococcal meningitis is caused by the fungus Cryptococcus neoformans, which is found in soil and bird droppings.
    • It first leads to the development of a lung infection and later a fatal brain infection.
    • Cryptococcal meningitis is a leading cause of adult meningitis in sub-Saharan Africa and it’s associated with almost 20% of all AIDS-related deaths.

Growing burden

    • While these factors are not unique to Africa, the burden of fungal diseases and the number of people who succumb to them is much greater.
    • The COVID pandemic seems to have made the global fungal burden worse.
    • COVID-induced lung damage, high blood sugar, and the steroids often used to treat it are all predisposing factors to black fungus infection.

But don’t we have antifungal drugs?

    • With poorly funded and overburdened healthcare systems, many African countries are not well prepared to deal with fungal infections.
    • Additionally, some of the WHO-recommended antifungal drugs – such as flucytosine – are unavailable in most African countries.

Management strategies


    Fungal threats are adding pressure to overburdened health systems with a limited arsenal of treatment options. Healthcare professionals, scientific researchers, policymakers and governments must address the gaps in the diagnosis and management of fungal infections. This will help to improve capacity to deal with them.

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.

Lundquist Institute Start-Up Vitalex Biosciences Awarded Grant from NIAID/NIH

Retrieved on: 
Tuesday, April 25, 2023
Infection, GLP, Charles H. Lundquist College of Business, Fungal infection, TLI, SBIR, National Institute of Allergy and Infectious Diseases, CMC, COVID-19, Encephalitis, Mucormycosis, Doctor of Philosophy, Bangladesh Technical Education Board, Mab, Disseminated disease, Investigational New Drug, Patient, Mortality, NIAID, Immunodeficiency, Creative Biolabs, IND, Disease, Pharmaceutical industry, Chemistry

Los Angeles, April 25, 2023 (GLOBE NEWSWIRE) -- The Lundquist Institute (TLI) start-up company, Vitalex Biosciences, has been awarded an SBIR Phase 2 grant from the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health.

Key Points: 
  • Los Angeles, April 25, 2023 (GLOBE NEWSWIRE) -- The Lundquist Institute (TLI) start-up company, Vitalex Biosciences, has been awarded an SBIR Phase 2 grant from the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health.
  • The grant is for Vitalex’s VX-01, a monoclonal antibody (mAB) program targeting the debilitating indication of the fungal disease, mucormycosis.
  • Vitalex Biosciences is in residence at BioLabs at The Lundquist, a state-of-the-art incubator space for life science start-ups.
  • “We are very proud to have received this prestigious award from NIAID,” said Ashraf Ibrahim, PhD, an Investigator at The Lundquist Institute and the founder and CEO of Vitalex Biosciences.

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

ET

Key Points: 
  • ET
    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.

Basilea reports preliminary 2022 revenues, exceeding guidance, and provides portfolio update

Retrieved on: 
Wednesday, January 11, 2023
Cryptococcosis, SAB, CLK, TARGET, Merck, New Drug Application, Staphylococcus aureus, FGFR, Regulation of tobacco by the U.S. Food and Drug Administration, Aspergillosis, CHF, PARG, DXR, Mucormycosis, Marketing, BARDA, Growth, Food, Subclinical infection, Patient, Research, ABSSSI, Glioblastoma, Gram-negative bacteria, Ceftobiprole, LR, Pharmaceutical industry, Vaccine, Isavuconazonium, EU

CHF 122 million, exceeding guidance by more than 17%

Key Points: 
  • CHF 122 million, exceeding guidance by more than 17%
    Ad hoc announcement pursuant to Art.
  • Revenue contributions from the antifungal Cresemba and the antibiotic Zevtera are expected to amount to approximately CHF 122 million (full-year 2022 guidance: CHF 98 million – 104 million).
  • David Veitch, Chief Executive Officer, commented: “We achieved significant milestones in 2022 and will continue to focus on delivering on our strategy to drive value creation going forwards.
  • By November 2022, Basilea had entered into three separate transactions with innovative oncology companies.

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

Matinas BioPharma Reports Third Quarter 2022 Financial Results and Highlights Recent Progress

Retrieved on: 
Wednesday, November 2, 2022
MD, DNA, Population, SEC, GLOBE, Brain, Research, NIH, EFA, National Institute of Neurological Disorders and Stroke, Phase 3, Anemia, Interim, Private Securities Litigation Reform Act, Company, Week, Kidney, Solution, Arm, Risk, Mycosis, LNC, HIV, Infectious Diseases Society of America, Mortality, Partnership, Board, NYSE, Oligonucleotide, Person, Safety, Incidence, Survival rate, Technology, Form 10-K, National, Investor, Patient, Interval (mathematics), Enactment, Director, Consultant, Mucormycosis, BioNTech, NINDS, Conference, Organic acid, IV, Cohort, RNA transfection, Survival, MBA, Lung, National Institute, Death, Cryptococcosis, Sale, Vaccine, Hand, CM, Forward-looking statement, Management, Communications satellite, Fine chemical, Pharmaceutical industry, Stroke

In April 2022, Matinas and BioNTech entered an exclusive research collaboration centered on the combination of Matinas proprietary LNC platform technology and BioNTech mRNA formats.

Key Points: 
  • In April 2022, Matinas and BioNTech entered an exclusive research collaboration centered on the combination of Matinas proprietary LNC platform technology and BioNTech mRNA formats.
  • The Company will host a live conference call and webcast to discuss these results today, November 2, 2022, at 4:30 p.m.
  • Matinas BioPharma is a biopharmaceutical company focused on improving the intracellular delivery of nucleic acids and small molecules with its lipid nanocrystal (LNC) platform technology.
  • Matinas BioPharmas product candidates are all in a development stage and are not available for sale or use.