National Institute of Allergy and Infectious Diseases

Melinta Therapeutics and Venatorx Pharmaceuticals Announce Licensing Agreement to Commercialize Cefepime-Taniborbactam in the U.S.

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목요일, 11월 9, 2023
Research, Infectious Diseases, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Other Science, Science, Wellcome Trust, Government, FDA, Biomedical Advanced Research and Development Authority, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Meropenem, PDUFA, Food, Cutis laxa, United States Department of Health and Human Services, Pyelonephritis, Melinta Therapeutics, End-user license agreement, Prescription Drug User Fee Act, Human services, Regulation of tobacco by the U.S. Food and Drug Administration, Urinary tract infection, R, Administration, QIDP, CDC, Pseudomonas aeruginosa, Regulation, Medicine, Partnership, Infection, AP, ESBL, NDA, License, Therapy, Patient, Bangladesh Technical Education Board, Pharmaceutical industry

The partnership follows Venatorx’s submission of a New Drug Application (NDA) for cefepime-taniborbactam for the treatment of cUTI including pyelonephritis, in adults.

Key Points: 
  • The partnership follows Venatorx’s submission of a New Drug Application (NDA) for cefepime-taniborbactam for the treatment of cUTI including pyelonephritis, in adults.
  • Venatorx has been assigned a Prescription Drug User Fee Act (PDUFA) target action date for February 22, 2024.
  • The U.S. Food and Drug Administration (FDA) granted cefepime-taniborbactam Qualified Infectious Disease Product (QIDP) and Fast Track designations for both the cUTI and HABP/VABP indications.
  • Venatorx has granted GARDP exclusive rights to distribute and sub-distribute cefepime-taniborbactam, once it is approved for clinical use, in low- and lower middle-income countries.

ATCC Announces Award from National Institute of Allergy and Infectious Diseases to Support Its Preclinical Services for Biopharmaceutical Product Development

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화요일, 11월 7, 2023
Research, Infectious Diseases, Stem Cells, Biotechnology, Health, Pharmaceutical, Other Science, Science, Oncology, National Institute of Allergy and Infectious Diseases, IND, DVM, Indefinite, NIAID, Senior, Private sector, IDIQ, NIH, Infection, Bangladesh Technical Education Board, Investigational New Drug, Pharmaceutical industry, ATCC

ATCC , the world’s premier biological materials management and standards organization, today announced that it has been awarded an Indefinite Delivery/Indefinite Quantity (IDIQ) contract 75N93023D00009 by the National Institute of Allergy and Infectious Diseases ( NIAID ), part of the National Institutes of Health (NIH).

Key Points: 
  • ATCC , the world’s premier biological materials management and standards organization, today announced that it has been awarded an Indefinite Delivery/Indefinite Quantity (IDIQ) contract 75N93023D00009 by the National Institute of Allergy and Infectious Diseases ( NIAID ), part of the National Institutes of Health (NIH).
  • With this contract, ATCC, as a member in the NIAID selected service provider pool, will support NIAID’s Preclinical Services for Biopharmaceutical Product Development in two main areas: the development and validation of analytical assays for product characterization and process development and formulation.
  • “This contract builds upon the work we are already doing with NIAID and several of their divisions, as well as our management of NIAID’s BEI Resources,” said Joseph Leonelli, Ph.D., Senior Vice President and General Manager of ATCC Federal Solutions.
  • “With our expertise and resources, NIAID is better able to more quickly diagnose infectious disease-causing pathogens and toxins, and then strive to develop therapeutic products to treat them.”

Aridis Pharmaceuticals Announces Third Quarter 2023 Financial Results and Business Update

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금요일, 11월 3, 2023
FDA, Research, Sale, National Institute of Allergy and Infectious Diseases, AstraZeneca, Ventilator-associated pneumonia, Antibiotic, Cystic Fibrosis Foundation, VAP, Omicron, NIAID, European Medicines Agency, OTCQB, Tenant, Development, Pharmacokinetics, Priority review, Data monitoring committee, Common stock, QIDP, Pseudomonas aeruginosa, Expense, Nature Communications, COVID-19, Cystic fibrosis, S. aureus, Emory University, EMA, Staphylococcus, Gallium, NIH, Safety, Infection, Patient, Administration, Mab, BLA, Bangladesh Technical Education Board, Respiratory tract, DSMB, ICU, Pharmaceutical industry, Vaccine, Security (finance)

LOS GATOS, Calif., Nov. 03, 2023 (GLOBE NEWSWIRE) -- Aridis Pharmaceuticals, Inc. (OTCQB: ARDS), a biopharmaceutical company focused on the discovery and development of novel anti-infective therapies for treating life-threatening infections, today reported financial and corporate results for its third quarter ended September 30, 2023.

Key Points: 
  • OTCQB companies must be current in their financial reporting and undergo an annual verification and management certification process.
  • We remain optimistic of successful outcomes from these efforts in the coming months,” commented Vu Truong, Ph.D., Chief Executive Officer of Aridis Pharmaceuticals.
  • Due to fair value option valuation of our notes payable, there was no interest expense recorded during the third quarter of 2023.
  • Other Income: Other income increased to $26,000 for the quarter ended September 30, 2023, compared to approximately $23,000 for the quarter ended September 30, 2022.

Tonix Pharmaceuticals’ Vaccine Candidate, TNX-1800, Selected by NIH/NIAID Project NextGen for Inclusion in Clinical Trials

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목요일, 11월 2, 2023
Monkeypox virus, FDA, National Institute of Allergy and Infectious Diseases, HHS, Food, Therapy, Vaccine, SARS-CoV-2, NIAID, Face, Mpox, Project, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Volunteering, Tonix Pharmaceuticals, Clinical trial, COVID-19, Smallpox, Nextgen, Animal, RPV, NIH, Safety, Office of Inspector General, U.S. Department of Health and Human Services, Infection, Tuberculosis, Bangladesh Technical Education Board

CHATHAM, N.J., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health (NIH), will conduct a Phase 1 clinical trial with TNX-1800 (recombinant horsepox virus, live vaccine),1 Tonix Pharmaceuticals’ vaccine candidate to protect against COVID-19.

Key Points: 
  • Tonix is developing a novel vaccine platform initially targeting COVID-19, smallpox and mpox (monkeypox).
  • The intent is to provide durable protection against severe disease and prevent forward transmission, primarily by eliciting a T-cell immune response.
  • “TNX-1800 will be the first vaccine candidate using our live virus recombinant pox virus (RPV) platform technology to enter clinical trials.
  • NIAID will be conducting clinical trials to evaluate several early-stage vaccine candidates.

New York Blood Center Enterprises Grants Exclusive License to Big Eye Diagnostics for Diagnostic Biomarkers in River Blindness

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수요일, 11월 1, 2023
National Institute of Allergy and Infectious Diseases, WHO, Onchocerciasis, MDA, Biomarker, Infection, NIAID, Research, Laboratory, Disease, World Health Organization, Risk, Mass drug administration, Partnership, Lindsley, Poverty, Onchocerca volvulus, NIH, Diagnosis, Bangladesh Technical Education Board, Pharmaceutical industry, Medical device

NEW YORK, Nov. 01, 2023 (GLOBE NEWSWIRE) -- New York Blood Center Enterprises (NYBCe) announced today it granted an exclusive commercial license to Big Eye Diagnostics for the rights to develop a diagnostic tool for onchocerciasis or river blindness.

Key Points: 
  • NEW YORK, Nov. 01, 2023 (GLOBE NEWSWIRE) -- New York Blood Center Enterprises (NYBCe) announced today it granted an exclusive commercial license to Big Eye Diagnostics for the rights to develop a diagnostic tool for onchocerciasis or river blindness.
  • River Blindness impacts 18 million individuals, with an additional 218 million at risk of contracting the disease.
  • Furthermore, the resulting solution could streamline deployment in the affected geographies, addressing a significant need in the fight against river blindness.
  • "This innovative work from NYBC and NIH provides the necessary foundation to improve diagnosis in a global effort to eliminate river blindness."

AIS Healthcare’s Advanced Infusion Care Announces Joint Study with Grifols to Continue Improving Patient Care

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월요일, 10월 23, 2023
General Health, Pharmaceutical, Health, Medical Devices, National Institute of Allergy and Infectious Diseases, Incidence, Physician, SCIG, Grifols, PID, Quality of life, Immunodeficiency, Partnership, Pharmacy, Infection, Pharmacist, Nursing, Patient, AIC, Vaccine

AIC and Grifols’ Satisfaction and Outcomes in Primary Immune Deficiency patients (SOPID) study will observe 60 patients across a three-month period who are beginning SCIG therapy.

Key Points: 
  • AIC and Grifols’ Satisfaction and Outcomes in Primary Immune Deficiency patients (SOPID) study will observe 60 patients across a three-month period who are beginning SCIG therapy.
  • “Grifols has an impressive track record of producing innovative, high-quality medicines for patients living with chronic and rare diseases.
  • The joint study between AIC and Grifols seeks to determine if there are differences in patient tolerability and satisfaction with immunoglobulin treatments, ensuring the best quality of care for patients living with immunodeficiencies.
  • In partnership with Grifols, the SOPID study will build on this work to assist physicians in better understanding how different SCIG products can maximize patient quality of life.

Over $3.7 million in NIH grants will fund research on impacts of climate change on HIV-related health outcomes

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수요일, 10월 18, 2023
WHO, CUNY, Research, UCSB, Graduate Center, CUNY, National Institute of Allergy and Infectious Diseases, Weather, UCSF, Temperature, Population health, Health, Health equity, Science, Public health, Global Climate and Health Alliance, Implementation Science, Climate, NIAID, Icahn School of Medicine at Mount Sinai, HIV, Diabetes, Food, R01, University, Geographic Locator Codes, PEPFAR, Medicine, Risk, HIV/AIDS, Hypertension, Mount Sinai, Health policy, NIH, SIG, Climate change, Area studies, UNAIDS, Drug resistance, Infection, Epidemiology, Pharmaceutical industry, Agriculture, Central Africa

"These climate-related factors likely also increase the risk of poor clinical outcomes among people living with HIV."

Key Points: 
  • "These climate-related factors likely also increase the risk of poor clinical outcomes among people living with HIV."
  • Work on the four-year R01 award will combine data sources uniquely suited to characterize the influence of extreme weather on HIV care outcomes.
  • This, in turn, can inform strategies to help mitigate the impacts of climate change and extreme weather on HIV care outcomes and the trajectory of the HIV pandemic.
  • The team is currently recruiting for a full-time Postdoctoral Fellow to focus on climate and health research, as well as a full-time Project Manager , to join the project team.

Presentations at IDWeek 2023 Highlight Potentially Differentiated Immunogenicity of Gritstone bio’s Next Generation COVID-19 Vaccine

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수요일, 10월 11, 2023
COVID-19, NIAID, National Institute of Allergy and Infectious Diseases, Vaccine, RNA, Immunity, Immunogenicity, Gritstone bio, Group A, Infection, PLWH, HIV, CORAL, Epitope, NAB, Reactogenicity, Messenger, Infectious Disease Clinics of North America, Pharmaceutical industry, Gritstone, Safety

EMERYVILLE, Calif., Oct. 11, 2023 (GLOBE NEWSWIRE) -- October 11, 2023 (GLOBE NEWSWIRE) – Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company working to develop the world’s most potent vaccines, today announced the presentation of results from three ongoing Phase 1 studies evaluating its self-amplifying mRNA (samRNA) vaccine candidates against COVID-19 (part of the company’s CORAL program) at IDWeek 2023, occurring October 11-15, 2023, in Boston, MA.

Key Points: 
  • Gritstone will present further follow up data from the CORAL-CEPI and CORAL-BOOST studies (most recent prior presentation in April 2023, press release ).
  • CORAL-BOOST (NCT05148962) is a Phase 1 study evaluating a samRNA-based COVID-19 vaccine candidate containing spike plus other viral targets in older adults ≥60 years of age (N = 40).
  • Broad T cell responses induced against Spike and non-Spike T cell epitopes included in the vaccine.
  • To view Gritstone’s IDWeek 2023 poster presentations, visit ir.gritstonebio.com/investors/events .

Ocugen Mucosal Vaccine Candidate OCU500 Selected by NIH/NIAID Project NextGen for Inclusion in Clinical Trials

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화요일, 10월 10, 2023
COVID-19, NIAID, Nextgen, Vaccine, Public, ChAdOx1, Therapy, Project, Inhalation, Infection, National Institute of Allergy and Infectious Diseases, Vaccination, Bangladesh Technical Education Board, BARDA, Pharmaceutical industry

Ocugen is developing a novel anti-viral mucosal vaccine platform initially targeting COVID-19 and influenza (flu).

Key Points: 
  • Ocugen is developing a novel anti-viral mucosal vaccine platform initially targeting COVID-19 and influenza (flu).
  • NIAID, with funding from Project NextGen, will cover the full cost of the clinical trials, including operations and related analysis.
  • Ocugen will be responsible for providing clinical trial materials and upon completion will have full right of reference to the findings, which Ocugen believes will provide clinical evidence to support the further development of the Company’s lead mucosal vaccine candidate.
  • Ocugen looks forward to this important next step in the development of its novel mucosal vaccine platform and further supporting the Company’s commitment to advancing public health.

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

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목요일, 10월 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.