Emergency Use Authorization

FDA Roundup: March 22, 2024

Retrieved on: 
Friday, March 22, 2024
Health, Capecitabine, PFAS, FCN, Dietary supplement, OCE, Risk, COVID-19, Patient, Warning, Tablet, Public, RNA, DNA, Animal, News, Plasma protein binding, Emergency Use Authorization, Human services, Role, System, SARS-CoV-2, Physical examination, Plasmodium vivax, Plasmodium falciparum, Highlight, Malaria, Heated tobacco product, CFR, Vaccination, Safety, DPD, Cosmetics, Growth, Vaccine, Plasmodium ovale, Marketing, Food, FDA, Multimedia, Ponatinib

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.

Co-Diagnostics, Inc. Reports Full Year 2023 Financial Results

Retrieved on: 
Thursday, March 14, 2024
PCR, Tuberculosis, COVID-19, Webcast, Research, EDT, Sale, Emergency Use Authorization, RSV, HPV, TB, FDA, Pharmaceutical industry

SALT LAKE CITY, March 14, 2024 /PRNewswire/ -- Co-Diagnostics, Inc. (NASDAQ: CODX), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced financial results for the full year ended December 31, 2023.

Key Points: 
  • SALT LAKE CITY, March 14, 2024 /PRNewswire/ -- Co-Diagnostics, Inc. (NASDAQ: CODX), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced financial results for the full year ended December 31, 2023.
  • Full Year 2023 Financial Results:
    Revenue of $6.8 million, down from $34.2 million during the prior year primarily due to the decline in global demand for the Logix Smart® COVID-19 tests.
  • Co-Diagnostics plans to continue the development of our TB, multiplex respiratory, and HPV tests throughout the year," said Brian Brown, Co-Diagnostics' Chief Financial Officer.
  • Co-Diagnostics will host a conference call and webcast at 4:30 p.m. EDT today to discuss its financial results with analysts and institutional investors.

InflaRx Announces Initiation of its Commitment Program for GOHIBIC®(vilobelimab) to Help Broaden Access for Eligible Patients

Retrieved on: 
Thursday, January 25, 2024
ANN, Death, Mortality, Patient, The Lancet, Intubation, Hospital, Intensive care medicine, FCCP, COVID-19 deaths, Internal medicine, Survival, Medicine, ECMO, Critical care, Food, Commitment, Disease, COVID-19, FDA, Therapy, IMV, Extracorporeal membrane oxygenation, Emergency Use Authorization, Physician, Pharmaceutical industry

InflaRx is determined to support broader access to GOHIBIC for eligible patients.

Key Points: 
  • InflaRx is determined to support broader access to GOHIBIC for eligible patients.
  • ANN ARBOR, Mich., Jan. 25, 2024 (GLOBE NEWSWIRE) -- InflaRx Pharmaceuticals Inc., a subsidiary of InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, announced today that the Company has launched The InflaRx Commitment Program (Commitment Program).
  • With today´s announcement, we are demonstrating our strong commitment to help make GOHIBIC available for the most affected COVID-19 patients as a potential life-saving therapy.
  • For detailed information about the Commitment Program and to file a claim, please visit this link: The InflaRx Commitment Program .

Co-Diagnostics, Inc. Completes Submission to FDA for Co-Dx PCR Pro

Retrieved on: 
Wednesday, December 27, 2023
TB, Food, RSV, Sale, Respiratory syncytial virus, FDA, Vaccine, Emergency Use Authorization, HPV, PCR, COVID-19, Smartphone, Tuberculosis, Diagnosis, Therapy

SALT LAKE CITY, Dec. 27, 2023 /PRNewswire/ -- Co-Diagnostics, Inc. (Nasdaq-CM: CODX) (the "Company" or "Co-Dx"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced that it has submitted its Co-Dx™ PCR COVID-19 test with Co-Dx PCR Pro™ instrument for review by the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA). The submission includes the PCR Pro instrument, COVID-19 detection test, and mobile app, all designed for use in point-of-care and at-home settings.

Key Points: 
  • The Company's Emergency Use Authorization submission is for the new Co-Dx PCR Pro instrument and COVID-19 test kit, designed for point-of-care and at-home.
  • The submission includes the PCR Pro instrument, COVID-19 detection test, and mobile app, all designed for use in point-of-care and at-home settings.
  • We are pleased to announce this submission to the FDA for this new platform."
  • *The Co-Dx PCR at-home and point-of-care platform (including the PCR Home™, PCR Pro, mobile app, and all associated test kits) is subject to review by the FDA and/or other regulatory bodies and is not yet available for sale.

Isothermal Nucleic Acid Amplification Technology Market worth $8.83 Bn by 2031 - Exclusive Report by InsightAce Analytic Pvt. Ltd.

Retrieved on: 
Friday, November 24, 2023
Preventive healthcare, ID, Conditional sentence, Prevalence, CMV, Viral load, US Foods, Coronavirus, Patient, Gynaecology, CE marking, NAT, FDA, Genetic testing, COVID-19, Emergency Use Authorization, CMS, Food and Drug Administration, Cancer, Cytomegalovirus, Medicare, Medicare Payment Advisory Commission, Obstetrics, Malaria, History of Stanford Medicine, Vaccine, Pharmaceutical industry, Grifols

Grifols (Spain), for example, received the CE Mark in June 2022 for the Procleix Plasmodium Assay, a nucleic acid test (NAT) specifically approved for screening blood donors for malaria.

Key Points: 
  • Grifols (Spain), for example, received the CE Mark in June 2022 for the Procleix Plasmodium Assay, a nucleic acid test (NAT) specifically approved for screening blood donors for malaria.
  • Hologic, Inc. (US) got US Food and Drug Administration (FDA) approval for the Aptima CMV Quant Assay in May 2022.
  • The viral load of cytomegalovirus (CMV) will be quantified in patients who have received an organ or stem cell transplant.
  • Since of the region's high prevalence of chronic diseases, technological advancement in isothermal nucleic acid amplification technology (INAAT), and increasing adoption of INAAT over conventional techniques, North America dominates the Isothermal Nucleic Acid Amplification Technology (INAAT) market.

Isothermal Nucleic Acid Amplification Technology Market worth $8.83 Bn by 2031 - Exclusive Report by InsightAce Analytic Pvt. Ltd.

Retrieved on: 
Friday, November 24, 2023
Preventive healthcare, ID, Conditional sentence, Prevalence, CMV, Viral load, US Foods, Coronavirus, Patient, Gynaecology, CE marking, NAT, FDA, Genetic testing, COVID-19, Emergency Use Authorization, CMS, Food and Drug Administration, Cancer, Cytomegalovirus, Medicare, Medicare Payment Advisory Commission, Obstetrics, Malaria, History of Stanford Medicine, Vaccine, Pharmaceutical industry, Grifols

Grifols (Spain), for example, received the CE Mark in June 2022 for the Procleix Plasmodium Assay, a nucleic acid test (NAT) specifically approved for screening blood donors for malaria.

Key Points: 
  • Grifols (Spain), for example, received the CE Mark in June 2022 for the Procleix Plasmodium Assay, a nucleic acid test (NAT) specifically approved for screening blood donors for malaria.
  • Hologic, Inc. (US) got US Food and Drug Administration (FDA) approval for the Aptima CMV Quant Assay in May 2022.
  • The viral load of cytomegalovirus (CMV) will be quantified in patients who have received an organ or stem cell transplant.
  • Since of the region's high prevalence of chronic diseases, technological advancement in isothermal nucleic acid amplification technology (INAAT), and increasing adoption of INAAT over conventional techniques, North America dominates the Isothermal Nucleic Acid Amplification Technology (INAAT) market.

Abbott Receives FDA Approval for HPV Test to Run on Alinity m, Offering Primary HPV Screening and Assessment of High-Risk Cancer-Causing Types of HPV

Retrieved on: 
Thursday, November 2, 2023
University, FDA, Human papillomavirus infection, Emergency Use Authorization, Cervical cancer, NYSE, Food, Infection, SARS-CoV-2, Physician, HPV, Pathology, Genotype, STI, PCR, Health, Hepatitis B, Aline Betancourt, CDC, HIV, Risk, HCV, Cancer, Risk assessment, HR, HIV-1, CMV, Woman, Hepatitis, EBV, Patient, Food and Drug Administration, HBV, Vaccine, Cytomegalovirus

There are many different strains of HPV, each with a unique genetic signature or genotype.

Key Points: 
  • There are many different strains of HPV, each with a unique genetic signature or genotype.
  • However, some commonly used HPV tests are not approved for primary screening and only deliver limited information regarding which of the many different genotypes of HPV are present.
  • The Alinity m high risk (HR) HPV assay is approved as a test for HPV detection and for use in routine cervical cancer screening as per professional medical guidelines.
  • "The Alinity m HR HPV assay was carefully designed to support patient care and streamline HPV testing."

MEDGENE'S RHDV2 VACCINE GRANTED CRITICAL LICENSE BY USDA'S CENTER FOR VETERINARY BIOLOGICS

Retrieved on: 
Thursday, November 2, 2023
Foreign animal disease, Virulence, United States Department of Agriculture, Health, Hope, Emergency Use Authorization, USDA, Rabbit hemorrhagic disease, Death, Vaccination, Disease, Immunity, Animal, Veterinary biologic, House Rabbit Society, Safety, Heart, Vaccine, Livestock

BROOKINGS, S.D., Nov. 2, 2023 /PRNewswire/ -- Medgene, an animal health company that produces highly-targeted platform vaccines, has been granted a Conditional Use License by the United States Department of Agriculture's Center for Veterinary Biologics (USDA-CVB) to further manufacture and distribute its vaccine targeted at Rabbit Hemorrhagic Disease (RHDV2).

Key Points: 
  • BROOKINGS, S.D., Nov. 2, 2023 /PRNewswire/ -- Medgene, an animal health company that produces highly-targeted platform vaccines, has been granted a Conditional Use License by the United States Department of Agriculture's Center for Veterinary Biologics (USDA-CVB) to further manufacture and distribute its vaccine targeted at Rabbit Hemorrhagic Disease (RHDV2).
  • Once contracted, RHDV2 is usually fatal and affects wild and domestic rabbit populations.
  • Medgene's Conditional Use License is especially important for designated State Veterinarians as they are the authority allowing distribution of the vaccine within their respective states.
  • Rabbit owners are encouraged to contact their local veterinarian for more information on RHDV2 and vaccination.

VERU INVESTIGATION INITIATED by Former Louisiana Attorney General: Kahn Swick & Foti, LLC Investigates the Officers and Directors of Veru Inc. - VERU

Retrieved on: 
Monday, October 16, 2023
Class Action Lawsuit, Professional Services, Legal, COVID-19, Food, KSF, EUA, COVID, Emergency Use Authorization, FDA, Regulation of tobacco by the U.S. Food and Drug Administration, Pharmaceutical industry, Verus Pharmaceuticals

Former Attorney General of Louisiana, Charles C. Foti, Jr., Esq., a partner at the law firm of Kahn Swick & Foti, LLC (“KSF”), announces that KSF has commenced an investigation into Veru Inc. (NasdaqCM: VERU).

Key Points: 
  • Former Attorney General of Louisiana, Charles C. Foti, Jr., Esq., a partner at the law firm of Kahn Swick & Foti, LLC (“KSF”), announces that KSF has commenced an investigation into Veru Inc. (NasdaqCM: VERU).
  • Then, on March 2, 2023, the Company announced that the FDA formally declined its EUA request.
  • KSF’s investigation is focusing on whether Veru’s officers and/or directors breached their fiduciary duties to its shareholders or otherwise violated state or federal laws.
  • About Kahn Swick & Foti, LLC
    KSF, whose partners include former Louisiana Attorney General Charles C. Foti, Jr., is one of the nation’s premier boutique securities litigation law firms.

Pfizer Presents New Data at IDWeek 2023 Highlighting Advances in Prevention and Treatment of Certain Respiratory Illnesses and Other Infectious Diseases

Retrieved on: 
Thursday, October 5, 2023
Biotechnology, Pharmaceutical, Oncology, General Health, Health, FDA, COVID-19, Clinical Trials, Pain, Shenzhen Kangtai Biological Products, Food, Gram-negative bacteria, Preterm birth, Act, Death, Ritonavir, Plasma, Treatment, Myalgia, Stevens–Johnson syndrome, EUA, Risk, Hospital, Jaundice, Emergency Use Authorization, Nausea, Allergy, Microsome, Headache, Fatigue, CYP3A, Immune system, Safety, History, Regulation of tobacco by the U.S. Food and Drug Administration, Gestational age, Post-exposure prophylaxis, Anaphylaxis, Patient, Medicine, Vaccine, Pharmaceutical industry, Birth control

PAXLOVID is not approved for use as pre-exposure or post-exposure prophylaxis for prevention of COVID-19.

Key Points: 
  • PAXLOVID is not approved for use as pre-exposure or post-exposure prophylaxis for prevention of COVID-19.
  • There are certain other drugs for which concomitant use with PAXLOVID should be avoided and/or dose adjustment, interruption, or therapeutic monitoring is recommended.
  • Drugs listed here are a guide and not considered a comprehensive list of all drugs that may be contraindicated with PAXLOVID.
  • Drugs that are primarily metabolized by CYP3A for which elevated concentrations are associated with serious and/or life-threatening reactions:
    Microsomal triglyceride transfer protein inhibitor: lomitapide