EUA

Cue Health Awarded New $28 Million Federal Contract to Develop Flu A/B, RSV, COVID-19 Molecular Multiplex Test for Both Over-the-Counter and Point-of-Care Use

Retrieved on: 
Thursday, August 3, 2023

The company has also applied with the U.S. FDA for Emergency Use Authorization (EUA) for its Cue Flu + COVID-19 Molecular Test for at-home and point-of-care (POC) use.

Key Points: 
  • The company has also applied with the U.S. FDA for Emergency Use Authorization (EUA) for its Cue Flu + COVID-19 Molecular Test for at-home and point-of-care (POC) use.
  • Cue also requested De Novo classification from the FDA for the Cue RSV Molecular Test for at-home and point-of-care use.
  • Cue also recently received De Novo authorization from the FDA for the same COVID-19 test (Cue COVID-19 Molecular Test), which was the first De Novo granted for any home use respiratory test available without a prescription.
  • The Cue molecular tests all run on the Cue Health Monitoring System (Reader), which has an installed base of more than a quarter million.

BD Receives 510(k) Clearance for COVID-19, Influenza A/B, RSV Molecular Combination Test

Retrieved on: 
Tuesday, August 1, 2023

FRANKLIN LAKES, N.J., Aug. 1, 2023 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the BD Respiratory Viral Panel (RVP) for BD MAX™ System, a single molecular diagnostic combination test that identifies and distinguishes SARS-CoV-2, influenza A, influenza B, and Respiratory Syncytial Virus (RSV) in approximately two hours.

Key Points: 
  • FRANKLIN LAKES, N.J., Aug. 1, 2023 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the BD Respiratory Viral Panel (RVP) for BD MAX™ System, a single molecular diagnostic combination test that identifies and distinguishes SARS-CoV-2, influenza A, influenza B, and Respiratory Syncytial Virus (RSV) in approximately two hours.
  • The BD RVP test helps eliminate the need for multiple individual tests or doctor visits and can help clinicians implement the right treatment plan quickly.
  • The BD Respiratory Viral Panel for BD MAX™ System was CE marked under the IVD directive 98/79/EC in May of 2022, and now with the 510(k) clearance, BD will discontinue the BD RVP EUA version and replace it with the 510(k) version, with no gaps in availability of the test.
  • The BD MAX™ open system also allows customers to leverage research use only (RUO) assays and user-defined protocols (UDP) to address emerging needs quickly.

Invivyd Announces Appointment of Sara Cotter to Board Of Directors

Retrieved on: 
Thursday, July 27, 2023

WALTHAM, Mass., July 27, 2023 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a clinical-stage biopharmaceutical company on a mission to protect the vulnerable from serious viral infectious diseases, today announced the appointment of Sara Cotter to its board of directors.

Key Points: 
  • WALTHAM, Mass., July 27, 2023 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a clinical-stage biopharmaceutical company on a mission to protect the vulnerable from serious viral infectious diseases, today announced the appointment of Sara Cotter to its board of directors.
  • Ms. Cotter brings extensive leadership experience spanning healthcare investment management and drug development.
  • Cotter’s comprehensive knowledge of the biopharmaceutical industry, pairing both operating and capital markets expertise, make her an excellent addition to our board of directors,” said Dave Hering, Chief Executive Officer of Invivyd.
  • Ms. Cotter received an M.B.A from the Kellogg School of Management at Northwestern University and a B.S.

DiaCarta and HMC/HML Team up for Customizing Lab Development Test Validations and Compliances in the US Market

Retrieved on: 
Monday, July 24, 2023

The partnership will help companies who have developed novel IVD tests but do not have the capacity to bring the products for FDA approval, or to take the tests to clinical labs to serve healthcare providers and patients.

Key Points: 
  • The partnership will help companies who have developed novel IVD tests but do not have the capacity to bring the products for FDA approval, or to take the tests to clinical labs to serve healthcare providers and patients.
  • “DiaCarta has established high-quality systems not only for its IVD products under ISO13485 compliance, but also the LDT testing venues at its CAP/CLIA lab in California.
  • “Not only do we have successful experiences validating LDT assays for our clients, DiaCarta has also closely worked with CMS for coding, billing and reimbursement of the new tests.”
    Both DiaCarta and HMC/HML will attend 2023 AACC Annual Scientific Meeting and Clinical Lab Expo on July 23 to 27, Anaheim, California.
  • Their products/services will be presented at booths #4451 for DiaCarta and #3474 for HMC/HML.

Biophytis: Biophytis has requested a pre-submission meeting with the FDA for an Emergency Use Authorization of Sarconeos (BIO101) for the treatment of COVID-19

Retrieved on: 
Thursday, July 20, 2023

Stanislas Veillet, Chief Executive Officer of Biophytis, commented: “We are actively pursuing our roadmap by initiating discussions with the FDA to bring our drug candidate to patients suffering from severe forms of COVID-19 in the United States.

Key Points: 
  • Stanislas Veillet, Chief Executive Officer of Biophytis, commented: “We are actively pursuing our roadmap by initiating discussions with the FDA to bring our drug candidate to patients suffering from severe forms of COVID-19 in the United States.
  • Like influenza, this pathology has become an endemic respiratory infectious disease that can lead to Acute Respiratory Distress Syndrome (ARDS) in elderly, immunocompromised or co-morbid patients.
  • According to the WHO, the medical need remains high, with several thousand deaths per week in the United States and Europe.
  • We look forward to starting discussions with the FDA, and depending on feedback from this agency, we could consider filing an Emergency Use Application by the end of 2023 or in the first half of 2024."

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

Retrieved on: 
Thursday, July 6, 2023

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.

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

Retrieved on: 
Thursday, July 6, 2023

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

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.

Invivyd Announces General Alignment with FDA on Pathway to Potential EUA for VYD222 and Anticipated Follow-On Monoclonal Antibody Candidates Designed to Prevent COVID-19

Retrieved on: 
Monday, June 26, 2023

Invivyd plans to leverage this immunobridging pathway to accelerate the clinical development of VYD222 and anticipated follow-on mAb candidates, with ADG20 (adintrevimab) or future proprietary mAbs serving as the prototype.

Key Points: 
  • Invivyd plans to leverage this immunobridging pathway to accelerate the clinical development of VYD222 and anticipated follow-on mAb candidates, with ADG20 (adintrevimab) or future proprietary mAbs serving as the prototype.
  • In June 2023, the company announced positive initial safety and serum neutralizing titer data from the ongoing Phase 1 VYD222 clinical trial.
  • Serum neutralizing titers are the same surrogate marker planned for use in the primary endpoint in a pivotal VYD222 clinical trial.
  • The company also continues to engage with global regulatory authorities regarding the VYD222 clinical development program.

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

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.