EUA

Cue Health Reports Third Quarter 2023 Financial Results

Retrieved on: 
Wednesday, November 8, 2023

Cue Health Inc. ("Cue") (Nasdaq: HLTH), a healthcare technology company, today reported financial results for the third quarter 2023.

Key Points: 
  • Cue Health Inc. ("Cue") (Nasdaq: HLTH), a healthcare technology company, today reported financial results for the third quarter 2023.
  • I’m proud of the Cue team for the strong execution across all fronts.”
    Revenue was $17.5 million for the third quarter of 2023.
  • GAAP net loss in the third quarter of 2023 was $47.0 million and earnings per diluted share was a loss of $0.31, an improvement of $0.24 from the second quarter of 2023.
  • Cue ended the third quarter with cash of $111.5 million and the company continues to operate with no debt obligations.

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

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.

Galactica Pharmaceuticals Announces the Online Publication of Newest COVID-19 Data at bioRxiv

Retrieved on: 
Wednesday, October 11, 2023

Galactica Pharmaceuticals, Inc., a biopharmaceutical company focused on developing novel fusion protein molecules, announced today the online publication of its recent COVID-19 in vivo animal data at bioRxiv.

Key Points: 
  • Galactica Pharmaceuticals, Inc., a biopharmaceutical company focused on developing novel fusion protein molecules, announced today the online publication of its recent COVID-19 in vivo animal data at bioRxiv.
  • We look forward to advancing our RAGE investigational drug into a Phase I/II COVID clinical trial in the coming months.
  • ”Millions of recovered COVID patients are still experiencing long- term COVID symptoms, often for many months post-recovery.
  • If that endpoint is met, Galactica expects to seek Emergency Use Authorization (EUA) from the United States Food and Drug Administration to quickly make the drug available to hospitalized COVID-19 patients.

ExThera Medical Awarded U.S. Federal Supply Schedule Contract for Seraph 100 Blood Filter

Retrieved on: 
Tuesday, October 10, 2023

ExThera Medical Corporation has been awarded a 5-year U.S. Department of Veterans Affairs (VA) Federal Supply Schedule (FSS) contract, which allows ExThera to pursue contracts with federal healthcare organizations including the U.S. Department of Veteran Affairs, U.S. Federal Prison System, Indian Reservations, and the Department of Defense.

Key Points: 
  • ExThera Medical Corporation has been awarded a 5-year U.S. Department of Veterans Affairs (VA) Federal Supply Schedule (FSS) contract, which allows ExThera to pursue contracts with federal healthcare organizations including the U.S. Department of Veteran Affairs, U.S. Federal Prison System, Indian Reservations, and the Department of Defense.
  • The contract grants streamlined access to the company’s Seraph® 100 MicroBind® Affinity Blood Filter.
  • Military and VA clinicians have been enthusiastic users of Seraph 100 for the treatment of COVID-19.
  • “ExThera is proud to be contracted by the Federal Supply Schedule, working closely with federal agencies to expand access to the Seraph 100.

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

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

Novavax 2023-2024 COVID-19 Vaccine Now Authorized and Recommended for Use in the U.S.

Retrieved on: 
Tuesday, October 3, 2023

In the coming days, individuals in the U.S. can go to pharmacies, physicians' offices, clinics and various government entities to receive an updated Novavax vaccine."

Key Points: 
  • In the coming days, individuals in the U.S. can go to pharmacies, physicians' offices, clinics and various government entities to receive an updated Novavax vaccine."
  • What should you mention to your vaccination provider before you or your child get the Novavax COVID-19 Vaccine, Adjuvanted?
  • A person should not get the Novavax COVID-19 Vaccine, Adjuvanted if they had:
    a severe allergic reaction after a previous dose of any Novavax COVID-19 Vaccine, Adjuvanted
    What are the risks of the Novavax COVID-19 Vaccine, Adjuvanted?
  • Women who are vaccinated with the Novavax COVID-19 Vaccine, Adjuvanted during pregnancy are encouraged to enroll in the registry by visiting https://c-viper.pregistry.com .

Novavax 2023-2024 COVID-19 Vaccine Now Authorized and Recommended for Use in the U.S.

Retrieved on: 
Tuesday, October 3, 2023

In the coming days, individuals in the U.S. can go to pharmacies, physicians' offices, clinics and various government entities to receive an updated Novavax vaccine."

Key Points: 
  • In the coming days, individuals in the U.S. can go to pharmacies, physicians' offices, clinics and various government entities to receive an updated Novavax vaccine."
  • What should you mention to your vaccination provider before you or your child get the Novavax COVID-19 Vaccine, Adjuvanted?
  • A person should not get the Novavax COVID-19 Vaccine, Adjuvanted if they had:
    a severe allergic reaction after a previous dose of any Novavax COVID-19 Vaccine, Adjuvanted
    What are the risks of the Novavax COVID-19 Vaccine, Adjuvanted?
  • Women who are vaccinated with the Novavax COVID-19 Vaccine, Adjuvanted during pregnancy are encouraged to enroll in the registry by visiting https://c-viper.pregistry.com .

Addressing the Cost vs. Quality Conundrum: 3EO Health Receives FDA Emergency Use Authorization, Launches Groundbreaking Point of Care Technology

Retrieved on: 
Monday, October 2, 2023

3EO expects to begin distributing products to physicians and consumers in November of this year.

Key Points: 
  • 3EO expects to begin distributing products to physicians and consumers in November of this year.
  • (Photo: Business Wire)
    Born out of Harvard’s Wyss institute, 3EO delivers a true low-cost, high-performing, easy-to-use platform.
  • “Our vision was to leverage breakthrough biochemistry to provide molecular performance at antigen pricing,” said Thomas Schaus, M.D., Ph.D., Head of Research at 3EO Health.
  • “Our patented and novel technology coupled with our unique engineering has enabled breakthroughs in ease of use, reliability, and cost.

Invivyd Announces Dosing of First Participant in CANOPY Phase 3 Pivotal Clinical Trial Investigating VYD222 for the Prevention of Symptomatic COVID-19 

Retrieved on: 
Monday, September 11, 2023

This clinical trial is designed to rapidly generate the clinical data needed to support a potential emergency use authorization (EUA) submission for VYD222.

Key Points: 
  • This clinical trial is designed to rapidly generate the clinical data needed to support a potential emergency use authorization (EUA) submission for VYD222.
  • CANOPY is expected to enroll approximately 750 participants in two cohorts (A and B) including 300 individuals who are significantly immunocompromised.
  • “The initiation of the CANOPY pivotal clinical trial marks a major milestone for Invivyd, and it is a significant step in our journey to rapidly advance VYD222 toward a potential EUA submission,” said Dave Hering, Chief Executive Officer of Invivyd.
  • It is this urgent public health need that drives us to advance important new therapeutics like VYD222 as quickly as possible.”

Pfizer and BioNTech Receive U.S. FDA Approval for 2023-2024 COVID-19 Vaccine

Retrieved on: 
Monday, September 11, 2023

Children under the age of 5 may be eligible to receive additional doses of this season’s vaccine if they have not already completed a three-dose series with previous formulations of a COVID-19 vaccine.

Key Points: 
  • Children under the age of 5 may be eligible to receive additional doses of this season’s vaccine if they have not already completed a three-dose series with previous formulations of a COVID-19 vaccine.
  • Pfizer and BioNTech have submitted data for their Omicron XBB.1.5-adapted monovalent COVID-19 vaccine to other regulatory authorities around the world.
  • The COVID-19 vaccines (COMIRNATY®) by Pfizer and BioNTech are based on BioNTech’s proprietary mRNA technology and were developed by both companies.
  • Report vaccine side effects to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS).