Plasmodium falciparum

FDA Roundup: March 22, 2024

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Friday, March 22, 2024
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On Thursday, the FDA updated the Breakthrough Devices Program webpage to update the device designations data and the marketing authorizations list.

Key Points: 
  • On Thursday, the FDA updated the Breakthrough Devices Program webpage to update the device designations data and the marketing authorizations list.
  • From launch of the Breakthrough Devices Program through December 31, 2023, in total, the FDA granted 933 Breakthrough Devices designations and authorized 95 Breakthrough Devices for marketing.
  • On Thursday, the FDA approved safety labeling changes for fluorouracil injection products.
  • These changes also enable the FDA to more effectively respond to new information on the safety and use of food contact substances.

On-Device AI Healthcare Company Noul Becomes First Korean Diagnostic Company to Join Swiss Malaria Group

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Monday, February 12, 2024
MMV, Annual report, Plasmodium falciparum, Blood, Terre des Hommes, Parasitism, Gesellschaft mit beschränkter Haftung, Human, Malaria, Tropical medicine, Patient, Diagnosis, Trial of the century, American Academy, Vaccine

The recognition of innovation in the malaria diagnostic solution, miLab™ MAL played a major role in Noul becoming an official member of the Swiss Malaria Group.

Key Points: 
  • The recognition of innovation in the malaria diagnostic solution, miLab™ MAL played a major role in Noul becoming an official member of the Swiss Malaria Group.
  • Dr. Taehwan Kim, Managing Director of noul GmbH said, "noul GmbH will play a pivotal role in global malaria diagnosis through its activities as a member of the Swiss Malaria Group.
  • Swiss Malaria Group said, "Noul's innovative diagnostic tools align perfectly with the Swiss Malaria Group's emphasis on innovative solutions in the fight against malaria.
  • Noul, which focuses on diagnostic solutions in blood and tissue diagnostics, has developed a cutting-edge digital microscopy-based malaria diagnostic tool, miLab™ MAL."

Researchers at KFSH&RC & KAUST Discover Gene Responsible for Reproduction of the Most Dangerous Malaria Strain

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Monday, February 5, 2024
Parasitism, Research, Immune system, Bacteria, KFSH, KAUST, Nature, Diagnosis, Medical laboratory, Pathology, RC, Plasmodium falciparum, Health, Malaria, Vaccine

RIYADH, Saudi Arabia, Feb. 05, 2024 (GLOBE NEWSWIRE) -- In a major scientific breakthrough, a research team from King Faisal Specialist Hospital and Research Centre (KFSH&RC), in collaboration with King Abdullah University of Science and Technology (KAUST), working alongside researchers from the UK, the US, and India, discovered a vital gene instrumental in combating malaria. This gene, termed PfAP2-MRP, is essential in the replication process of Plasmodium falciparum, the parasite that causes the most lethal strain of malaria.

Key Points: 
  • This gene, termed PfAP2-MRP, is essential in the replication process of Plasmodium falciparum, the parasite that causes the most lethal strain of malaria.
  • Advanced laboratory techniques enabled the researchers to inhibit the PfAP2-MRP gene, revealing its critical role in the malaria parasite’s life cycle within red blood cells.
  • This inhibition significantly disrupts the parasite’s ability to reproduce, reducing the severity of the disease’s symptoms and curbing its spread.
  • This discovery is particularly impactful as it addresses Plasmodium falciparum malaria, which claims over half a million lives annually.

Fosun Pharma's Global Multi-Center Phase III Clinical Trial Project for A New Antimalarial Drug Receives 500 Million Japanese Yen Investment from GHIT Fund to Jointly Improve the Global Accessibility of Antimalarial Drugs

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Thursday, December 14, 2023
Knowledge, Plasmodium falciparum, Global health, Parasitism, Research, Malaria, Incidence, MMV, Greater Mekong Subregion, WHO, Disease, Tablet, Project, Fosun Pharma, Patient, Death, Artesunate, Amodiaquine, Infection, University, Partnership, GMS, Marubeni, Child, Pharmaceutical industry, Plasmodium

This is the first time GHIT Fund has invested in a research project led by a Chinese pharmaceutical company.

Key Points: 
  • This is the first time GHIT Fund has invested in a research project led by a Chinese pharmaceutical company.
  • Importantly, the project includes the development of a co-formulated child-friendly version, given that most malaria cases are in children[3].
  • Wen Deyong, CEO of Fosun Pharma, said, "We are very pleased to work with GHIT Fund to promote the clinical research on this antimalarial innovator drug.
  • Fosun Pharma has actively carried out community-oriented "Child Malaria Prevention Knowledge Popularization Projects" in 14 malaria-endemic countries in Africa.

AI Diagnostic Platform Company Noul, unveils the result of Malaria study in Ethiopia and Ghana

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Monday, October 23, 2023
Plasmodium falciparum, Research, Real-time, Trial of the century, Global health, Exhibition, Incidence, University of Notre Dame, Parasitism, Korea Human Rights Foundation, History, Prevalence, Infection, Malaria, UNITAID, RDT, R, Society, Artificial intelligence, Plasmodium vivax, Tropical medicine, Hematological Cancer Research Investment and Education Act, Clinical trial, Diagnosis, Risk, Annual report, Partnership, University of Science and Technology, Annual general meeting, Blood, University, Public, American Society of Tropical Medicine and Hygiene, Patient, University of Gondar, Pharmaceutical industry, Medical imaging, Medical device, Typhoon Noul (2015), Plasmodium, Hygiene

In the study, the scientists compared the sensitivity and specificity of the qPCR with those of miLab™, field microscopy, and Rapid Diagnostic Test (RDT) respectively.

Key Points: 
  • In the study, the scientists compared the sensitivity and specificity of the qPCR with those of miLab™, field microscopy, and Rapid Diagnostic Test (RDT) respectively.
  • Diagnosis of P. falciparum infections included cases with hrp2/hrp3 gene deletion with renders parasites 'invisible' to common rapid diagnostic tests.
  • Also, the diagnostic results of miLab™ in P. falciparum infected patients with hrp2/hrp3 gene deletion have been released.
  • This new study in Ethiopia and Ghana confirmed the clinical performance of miLab™ as a reliable new tool in the diagnosis of P. falciparum and P. vivax malaria.

60 Degrees Pharmaceuticals Receives Additional U.S. Patent Covering Tafenoquine for Prevention of Plasmodium Falciparum Malaria

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Tuesday, August 22, 2023
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Tafenoquine is the active molecule in ARAKODA®, the Company’s FDA-approved drug for malaria prevention in individuals aged 18 years and older for up to six months of continuous dosing.

Key Points: 
  • Tafenoquine is the active molecule in ARAKODA®, the Company’s FDA-approved drug for malaria prevention in individuals aged 18 years and older for up to six months of continuous dosing.
  • Travelers from and residents of the United States are usually malaria naïve, that is, they have not previously contracted malaria and thus lack immunity to the disease.
  • 60P initially received a U.S. patent in 2019 for tafenoquine for the prevention of P. falciparum malaria in naïve individuals aged 18 years of age or older.
  • The current patent award is a continuation of the application for that original patent.

Hesperos Scientists Publish a New Study in Scientific Reports Titled: "Development of a Human Malaria-on-a-Chip Disease Model for Drug Efficacy and Off-Target Toxicity Evaluation"

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Wednesday, July 5, 2023
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In 2021 the World Health Organization reported 247 million cases of malaria - 619,000 of which resulted in loss of human life.

Key Points: 
  • In 2021 the World Health Organization reported 247 million cases of malaria - 619,000 of which resulted in loss of human life.
  • Through their efforts they developed a human-based model to study the disease pathology and therapeutic effects in a pre-clinical platform.
  • This microfluidic platform connects human liver, spleen, and endothelium with recirculating human erythrocytes in a controlled, self-contained platform.
  • This new approach to the evaluation of Plasmodium falciparum and anti-malarial therapeutics is executed in a realistic human model.

Researchers discover new weapon against antibiotic resistance --it also fights malaria

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Thursday, June 29, 2023
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MIAMI, June 29, 2023 /PRNewswire/ -- FIU scientists discovered the first and only known natural arsenic-containing antibiotic to fight antibiotic resistance.

Key Points: 
  • MIAMI, June 29, 2023 /PRNewswire/ -- FIU scientists discovered the first and only known natural arsenic-containing antibiotic to fight antibiotic resistance.
  • Now, research reveals it can stop transmission of a deadly disease spreading in the U.S. for the first time in 20 years: malaria.
  • Collaborating with malaria researchers in the College of Arts, Sciences & Education , they've recently also found AST prevents Plasmodium falciparum, the parasite that causes malaria, from infecting mosquitoes — unlike other current antimalarial drugs.
  • When FIU researchers tested AST on liver, kidney and intestinal cells, AST targeted the malaria parasite lurking in human cells, but didn't damage the cells themselves.

Ocean Biomedical, Inc. (NASDAQ: OCEA) Announces Malaria Vaccine Patent Granted in Brazil, the 25th Patent Allowance for Programs in Infectious Disease, Cancer and Fibrosis

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Thursday, June 8, 2023
Vaccine, Executive, Partnership, Medical laboratory, Ocean Biomedical, Parasitism, Malaria, RI, Infection, Medicine, Research, Doctor of Philosophy, Fibrosis, Science, MD, Data, Pathology, Alpert Medical School, Parasitemia, Artemisinin, Death, IND, Family, Plasmodium falciparum, Pharmaceutical industry, Patent

Providence, RI, June 08, 2023 (GLOBE NEWSWIRE) -- Ocean Biomedical, Inc. (NASDAQ: OCEA) announced today that Scientific Co-founder Dr. Jonathan Kurtis, MD, PhD has been granted a new patent for his malaria vaccine discoveries that may be used to interdict the parasite at multiple stages in the malaria cycle. This extends patent protection for Dr. Kurtis’ novel discoveries that have defined the powerful roles of PfGARP and PfCDPK-5 in controlling the malaria parasite’s ability to aggressively multiply within its human host.

Key Points: 
  • This extends patent protection for Dr. Kurtis’ novel discoveries that have defined the powerful roles of PfGARP and PfCDPK-5 in controlling the malaria parasite’s ability to aggressively multiply within its human host.
  • This patent adds to Ocean Biomedical’s global patent portfolio for discoveries with potential to impact major unmet medical needs in infectious disease, oncology , and fibrosis .
  • Ocean Biomedical is working to optimize the formulation of this vaccine prior to IND submission and first-in-humans testing.
  • This medicine will be an additional focus of Ocean Biomedical’s development pipeline in 2023 and will address a massive unmet need.

Ocean Biomedical (NASDAQ: OCEA) on World Malaria Day Announces Sharing of New Malaria Vaccine Paradigm at PATH Malaria Research Retreat in Washington, DC, by Scientific Co-founder Dr. Jonathan Kurtis

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Tuesday, April 25, 2023
Vaccine, Goodwill, Monoclonal antibody, Therapy, Parasitism, Climate, PATH, Medical laboratory, RI, DC, Malaria, Research, Attention, ZERO, Doctor of Philosophy, Parliament, Pan-African Parliament, Death, Plasmodium falciparum, MD, Pathology, Brown University, SE, Artemisinin, Alpert Medical School, World Health Organization, Pharmaceutical industry, Southeast Asia, Ocean Biomedical

By targeting each of the three principle events in the parasite’s blood stage lifecycle, Ocean Biomedical believes this powerful approach will result in a highly effective and novel malaria vaccine.

Key Points: 
  • By targeting each of the three principle events in the parasite’s blood stage lifecycle, Ocean Biomedical believes this powerful approach will result in a highly effective and novel malaria vaccine.
  • The company is also working to develop the PfGARP component as a therapeutic target for a whole new class of anti-malarial drugs.
  • This discovery has allowed Ocean Biomedical to begin simultaneously pursuing the development of a novel malaria vaccine, and novel malaria therapeutics.
  • “I join the World Health Organization 2023 in saying, it is time for ZERO Malaria.”