Emergency Use Authorization

Novavax's Nuvaxovid™ Receives Full Marketing Authorization in the EU for the Prevention of COVID

Retrieved on: 
Thursday, July 6, 2023
EUA, Autumn, Use, Centers for Disease Control and Prevention, Allergy, Medicine, Civil service commission, Arthralgia, Vaccination, Hospital, Completeness, Chills, Section, Fever, COVID-19, Immunodeficiency, European Directive on Traditional Herbal Medicinal Products, Coronavirus, Myocarditis, Pericarditis, COVID, History, Marketing, Person, Immunocompetence, CDC, Committee, Myalgia, Messenger, Hypoesthesia, Emergency Use Authorization, Anaphylaxis, European, VAERS, NVAX, European Medicines Agency, Ageing, FDA, Headache, Death, Regulation of tobacco by the U.S. Food and Drug Administration, Paresthesia, MIS, FD, Multisystem inflammatory syndrome, Food, European Commission, Safety, Financial Services and Markets Authority (Belgium), Vaccine, Pharmaceutical industry, EU, Novavax COVID-19 vaccine, Adjuvant, Novavax

Monitor the Novavax COVID-19 Vaccine, Adjuvanted recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control (CDC) and Prevention guidelines .

Key Points: 
  • Monitor the Novavax COVID-19 Vaccine, Adjuvanted recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control (CDC) and Prevention guidelines .
  • Altered Immunocompetence: Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Novavax COVID-19 Vaccine, Adjuvanted.
  • Myocarditis, pericarditis, anaphylaxis, paresthesia, and hypoesthesia have been reported following administration of the Novavax COVID-19 Vaccine, Adjuvanted outside of clinical trials.
  • The reports should include the words "Novavax COVID-19 Vaccine, Adjuvanted EUA" in the description section of the report.

LumiraDx Submits First 510(k) Application to the FDA for COVID Ultra Test

Retrieved on: 
Friday, June 30, 2023
EUA, SARS-CoV-2, COVID-19, CLIA, Emergency Use Authorization, Ultra, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Safety, Medical device, Vaccine

LumiraDx submitted a traditional 510(k) Dual Submission for LumiraDx SARS-CoV-2 Ag Ultra with CLIA Waiver for the commercial distribution at point of care of the LumiraDx Platform, including the LumiraDx Instrument, with the LumiraDx SARS-CoV-2 Antigen (Ag) Ultra test, and the LumiraDx SARS-CoV-2 Ag Quality Control Swab Kit.

Key Points: 
  • LumiraDx submitted a traditional 510(k) Dual Submission for LumiraDx SARS-CoV-2 Ag Ultra with CLIA Waiver for the commercial distribution at point of care of the LumiraDx Platform, including the LumiraDx Instrument, with the LumiraDx SARS-CoV-2 Antigen (Ag) Ultra test, and the LumiraDx SARS-CoV-2 Ag Quality Control Swab Kit.
  • The LumiraDx SARS-CoV-2 Ag Ultra Test is a state-of-the-art diagnostic test that leverages LumiraDx's cutting-edge technology to detect the presence of SARS-CoV-2, the virus responsible for COVID-19.
  • "We are thrilled to announce the submission of our first 510(k) application to the FDA for the clearance of our COVID Ultra Test," said Carol Adiletto-Francis, Global SVP, Clinical Regulatory & Quality at LumiraDx.
  • The submission of this first 510(k) application represents a significant milestone in the company's journey towards receiving FDA approval for the COVID Ultra Test.

InflaRx Appoints Dr. Camilla Chong as Chief Medical Officer

Retrieved on: 
Wednesday, June 28, 2023
Emergency Use Authorization, Faculty, University College London, GSK plc, Drug development, Therapy, Quality of life, Faculty of Pharmaceutical Medicine, CMO, Dermatology, MD, Patient, Cardiology, FDA, Pharmaceutical medicine, Pfizer, Pharmaceutical industry, Teva

JENA, Germany, June 28, 2023 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company commercializing and developing anti-inflammatory therapeutics that target the complement system, today announced the appointment of Dr. Camilla Chong as Chief Medical Officer (CMO) of InflaRx, effective July 1, 2023.

Key Points: 
  • JENA, Germany, June 28, 2023 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company commercializing and developing anti-inflammatory therapeutics that target the complement system, today announced the appointment of Dr. Camilla Chong as Chief Medical Officer (CMO) of InflaRx, effective July 1, 2023.
  • Dr. Chong is a medical doctor with extensive experience in the pharmaceutical industry, including leadership roles in clinical development, medical affairs and overseeing the launch of new drugs across multiple geographies.
  • Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx, commented: “We are excited to welcome Camilla to our team.
  • She joins InflaRx from Kyowa Kirin Corporation, where she was Vice President & Global Medical Affairs Therapy Area Head - Immunology.

InflaRx Announces Commercial Launch of Gohibic (vilobelimab) in the U.S. for the Treatment of Critically Ill COVID-19 Patients

Retrieved on: 
Wednesday, June 21, 2023
EUA, Biologics license application, IMV, Therapy, The Lancet, Extracorporeal membrane oxygenation, European Medicines Agency, COVID-19, Survival, ECMO, European Directive on Traditional Herbal Medicinal Products, EMA, Hospital, Emergency Use Authorization, Patient, Investment, Mortality, Marketing Authorisation Application, FDA, Regulation of tobacco by the U.S. Food and Drug Administration, BLA, Food, CHMP, Pharmaceutical industry, Vaccine

Gohibic is currently the only drug directed against the complement factor C5a that is authorized for the treatment of certain critically ill COVID-19 patients.

Key Points: 
  • Gohibic is currently the only drug directed against the complement factor C5a that is authorized for the treatment of certain critically ill COVID-19 patients.
  • InflaRx is continuing discussions with the FDA related to the submission of a Biologics License Application (BLA) for a potential future full approval of Gohibic.
  • Dr. Thomas Taapken, Chief Financial Officer of InflaRx, commented: “We have built an excellent core commercial team to support the launch and distribution to U.S. hospitals.
  • The Company will provide updates on the status of regulatory submissions in the U.S. and elsewhere once available.

Applied BioCode Announces the Launch of the Fungal Panel Assay for Research Use

Retrieved on: 
Monday, June 12, 2023
Research, Technology, Infectious Diseases, Other Technology, Other Health, Biotechnology, Pharmaceutical, Health, Science, Other Science, EUA, UDM, Hair, Infection, Bachelor, BMB, Allergy, Workflow, RPP, Culture, SARS-CoV-2, Software, Pneumocystis jirovecii, COVID-19, Eye, Aspergillus, Histoplasma capsulatum, CE marking, PCR, Nomenclature codes, Immunochemistry, Emergency Use Authorization, Federal Food, Drug, and Cosmetic Act, Panel, Coccidioides, RSV, RUO, Patient, Laboratory, Autoimmune disease, Molecular Probes, IVD, Growth, GPP, Immunodeficiency, Diagnosis, FDA, Mucor, Virus, Vaccine, Rhizopus, Applied Spectral Imaging, Rhizomucor, Fusarium, Cunninghamella, Cryptococcus

The Fungal Panel Assay was developed to detect the most common agents of invasive fungal infections (IFIs) particularly in lower respiratory samples.

Key Points: 
  • The Fungal Panel Assay was developed to detect the most common agents of invasive fungal infections (IFIs) particularly in lower respiratory samples.
  • Applied BioCode’s Fungal Panel is intended for research use only and may be used in infectious disease research or pharmaceutical development.
  • “Applied BioCode is thrilled to announce our first release of an RUO panel under our new product strategy.
  • Applied BioCode, Inc. has also been granted an Emergency Use Authorization (EUA) from the U.S. FDA for its BioCode® SARS-CoV-2 Flu Plus Assay ⱡ, BioCode® SARS-CoV-2 Assay*, and an additional EUA for Pooled COVID-19 Testing*.

Veru Reports Fiscal 2023 Second Quarter Financial Results

Retrieved on: 
Thursday, May 11, 2023
Operating cost, Internet, Telephone, Oxygen, Survival, Incidence, Capsule, Patient, Finasteride, Eli Lilly and Company, GPO, SERD, Agreement, Telehealth, BPH, Drug discovery, Animal law, Enobosarm, Metastasis, Comorbidity, FC2, FDA, IND, Combination, Safety, EUA, High Risk, CDK, COVID-19, Metastatic breast cancer, AGS, Trust, Mortality, LPC, ORR, SARS-CoV-2, NDA, Quality of life, Pharmacy, Prostate, Sale, Trial of the century, Emergency Use Authorization, Tadalafil, Treatment, Breast cancer, Vaccine, Pharmaceutical industry, Birth control, Reinsurance, Cryptocurrency, Virus

ET

Key Points: 
  • ET
    MIAMI, FL, May 11, 2023 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of breast cancer and for SARS-CoV-2 and other viral ARDS-related diseases, today announced financial results for its fiscal 2023 second quarter and provided a business update.
  • On March 30, 2023, the Company met with the FDA to gain further regulatory clarity for the ongoing Phase 2b/3 clinical trial design and program.
  • Cash and cash equivalents were $23.5 million as of March 31, 2023 versus $80.2 million as of September 30, 2022.
  • To join the conference call via telephone, please dial 1-800-341-1602 (domestic) or 1-412-902-6706 (international) and ask to join the Veru Inc. call.

Biophytis launches a round of fundraising for approximately 2 million euros

Retrieved on: 
Wednesday, May 10, 2023
EUA, 20F, Euronext Growth, CET, Therapy, Code, Marketing, Bookrunner, Reserved, COVID-19, Ageing, Emergency Use Authorization, China Investment Securities, Overalls, Mass meeting, Attention, Risk, Annual general meeting, EMA, European Medicines Agency, EUR, Criticism of the Food and Drug Administration, Euronext, Patient, ISIN, Combined, Marketing Authorisation Application, FDA, MAA, Death, Marketing authorisation, Food, Respiratory failure, Cryptocurrency, Pharmaceutical industry, Auction, Security (finance), Risk management

The price of the shares allocated in connection with the PrimaryBid Offer will be identical to that determined for the Reserved Offer.

Key Points: 
  • The price of the shares allocated in connection with the PrimaryBid Offer will be identical to that determined for the Reserved Offer.
  • For the PrimaryBid Offer, investors will be able to subscribe exclusively through the PrimaryBid partners indicated on the PrimaryBid site (www.PrimaryBid.fr).
  • The risk factors presented in said documents are identical on the date of this press release.
  • Such events could have a significant adverse impact on the market price of Biophytis shares.

Talis Biomedical Corporation (TLIS) Investor News: Robbins LLP Reminds Investors it is Investigating TLIS on Behalf of Shareholders

Retrieved on: 
Tuesday, May 9, 2023
EUA, IPO, Registration statement, Urinary tract infection, Infection, COVID-19, Complaint, Register, Emergency Use Authorization, SAN, Health, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Pharmaceutical industry, Talis

The Talis One tests are being developed for respiratory infections, infections related to women's health, and sexually transmitted infections.

Key Points: 
  • The Talis One tests are being developed for respiratory infections, infections related to women's health, and sexually transmitted infections.
  • If you would like more information about our investigation of Talis Biomedical Corporation's misconduct, click here .
  • According to a class action complaint filed on behalf of Talis shareholders, Talis made false and misleading statements in connection with its February 2021 IPO.
  • What Now: Talis Biomedical Corporation (TLIS) shareholders have legal options.

Biophytis has requested a pre-submission meeting with the EMA for the Marketing Authorisation of Sarconeos (BIO101) for the treatment of COVID-19

Retrieved on: 
Tuesday, May 9, 2023
EUA, Euronext Growth, CET, Therapy, COVID-19, Ageing, Emergency Use Authorization, CMA, EMA, European Medicines Agency, Food and Drug Administration, Marketing authorisation, Patient, Access, Risk, FDA, Death, Food, Respiratory failure, Pharmaceutical industry

This is the first step in the regulatory process that the company is undertaking to define the eligibility and conditions for conditional Marketing Authorisation application in Europe for Sarconeos (BIO101) in the treatment of severe forms of COVID-19.

Key Points: 
  • This is the first step in the regulatory process that the company is undertaking to define the eligibility and conditions for conditional Marketing Authorisation application in Europe for Sarconeos (BIO101) in the treatment of severe forms of COVID-19.
  • A request for a pre-submission meeting with the Food and Drug Administration (FDA) for an Emergency Use Authorisation (EUA) application in the US is expected to be filed later this quarter.
  • The meeting with the EMA will allow definition of the eligibility and conditions for filing a conditional marketing authorisation application, this time at European level.
  • Depending on EMA's recommendations, we could envision filing a conditional MA in the second half of 2023 or the first half of 2024.

Applied BioCode Announces Distribution Agreement with Medline Industries

Retrieved on: 
Monday, May 8, 2023
Infectious Diseases, Biotechnology, Hospitals, Health, EUA, Hair, Bachelor, BMB, Allergy, RPP, Medline Industries, SARS-CoV-2, COVID-19, Infection, CE marking, Applied Food Technologies, MEDLINE, Nomenclature codes, Lower respiratory tract infection, Immunochemistry, Emergency Use Authorization, Federal Food, Drug, and Cosmetic Act, Hospital, RSV, Analyte-specific reagent, Laboratory, Autoimmune disease, Molecular Probes, LDT, IVD, Diagnosis, GPP, FDA, Virus, Pharmaceutical industry, Vaccine

Applied BioCode today announced an agreement with Medline Industries, a leading manufacturer and distributor of healthcare products, to distribute the MDx-3000 System and its comprehensive menu.

Key Points: 
  • Applied BioCode today announced an agreement with Medline Industries, a leading manufacturer and distributor of healthcare products, to distribute the MDx-3000 System and its comprehensive menu.
  • Under the terms of the distribution agreement, Medline will offer the MDx-3000 System to clinical laboratory customers across the U.S.
    “Applied BioCode is thrilled to partner with Medline Industries, and we look forward to continuing our expansion into hospitals and reference laboratories in the U.S.,” said Chris Bernard, CEO of Applied BioCode.
  • For more information on the Applied BioCode’s platform and products, visit: https://apbiocode.com/products.htm
    Applied BioCode is an IVD manufacturer that designs, develops, and commercializes multiplex testing products.
  • Applied BioCode, Inc. has also been granted an Emergency Use Authorization (EUA) from the U.S. FDA for its BioCode® SARS-CoV-2 Flu Plus Assay ⱡ, BioCode® SARS-CoV-2 Assay*, and an additional EUA for Pooled COVID-19 Testing*.