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Invivyd Provides PEMGARDA™ Launch Update and Announces 2024 Net Product Revenue Guidance in the Range of $150 Million to $200 Million

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목요일, 4월 4, 2024

Pre-exposure prophylaxis, Webcast, COVID-19, Patient, Health care, SARS-CoV-2, Vaccination, Safety, Immunodeficiency, FDA, Food, Vaccine

Recipients should not be currently infected with or have had a known recent exposure to an individual infected with SARS-CoV-2.

Key Points:

Recipients should not be currently infected with or have had a known recent exposure to an individual infected with SARS-CoV-2.
With product now available, today we are providing initial PEMGARDA net product revenue guidance in the range of $150 million to $200 million for the full year 2024.
For additional information about PEMGARDA, please see the full product Fact Sheet for Healthcare Providers, including important safety information and boxed warning.
Those who plan on participating are advised to join 15 minutes prior to the start time.

Invivyd Reports Full Year 2023 Financial Results and Recent Business Highlights

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목요일, 3월 28, 2024

Hook effect, Administration, U.S. FDA, Pre-exposure prophylaxis, Risk, COVID-19, Ageing, SARS-CoV-2, Research and development, Clinical trial, Vaccination, Immunodeficiency, Food, FDA, Vaccine

“We made remarkable progress throughout 2023 and in recent months.

Key Points:

“We made remarkable progress throughout 2023 and in recent months.
Recipients should not be currently infected with or have had a known recent exposure to an individual infected with SARS-CoV-2.
Cash Position: Cash and cash equivalents were $200.6 million as of December 31, 2023.
Basic and diluted net loss per share was $1.81 for the year ended December 31, 2023, compared to $2.23 for the year ended December 31, 2022.

Invivyd Announces FDA Authorization for Emergency Use of PEMGARDA™ (Formerly VYD222) for Pre-exposure Prophylaxis (PrEP) of COVID-19

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금요일, 3월 22, 2024

Recipients should not be currently infected with or have had a known recent exposure to an individual infected with SARS-CoV-2.

Key Points:

Recipients should not be currently infected with or have had a known recent exposure to an individual infected with SARS-CoV-2.
“The PEMGARDA EUA marks a transformational moment for Invivyd and for the many moderately to severely immunocompromised people who are vulnerable to COVID-19 disease in the U.S.
It was developed using INVYMAB™, the company’s platform approach which combines state-of-the-art viral surveillance and predictive modeling with advanced antibody engineering.
The severity of the reactions was generally mild (17/27) or moderate (8/27), but two reactions were life-threatening.

3EO Health Announces the First Point of Care Molecular Test Under $15

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목요일, 3월 28, 2024

Science, Other Science, Biotechnology, Medical Supplies, General Health, Health, COVID-19, Health Technology, Patient, Acquisition, Workflow, POC, Multimedia, Physician, Family, Work, Perfusion

3EO Health , a “Point of Life” diagnostics company focused on the development of high-performing low-cost molecular diagnostics, is excited to announce the next step in their quest to make molecular testing affordable.

Key Points:

3EO Health , a “Point of Life” diagnostics company focused on the development of high-performing low-cost molecular diagnostics, is excited to announce the next step in their quest to make molecular testing affordable.
View the full release here: https://www.businesswire.com/news/home/20240327647032/en/
3EO high efficiency molecular 3TR technology enables testing to be executed in multiple settings and locations.
With a cost per test up to 70% lower than existing technologies, 3EO is seeking to create access to molecular technology for more physicians and consumers by providing molecular POC tests under $15.
3EO Health received EUA authorization for its COVID-19 test utilizing 3TR technology in Q4 of 2023.

COVID-19 Monthly Newsletter Service - ResearchAndMarkets.com

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목요일, 3월 14, 2024

The "COVID-19 Monthly Snapshot" newsletter has been added to ResearchAndMarkets.com's offering.

Key Points:

The "COVID-19 Monthly Snapshot" newsletter has been added to ResearchAndMarkets.com's offering.
In November 2023, 64 investigational drugs were active in Phase 3 of clinical development.
Globally, the overall confirmed cases of COVID-19 reached more than 772 million as of November 22, 2023.
Fifty-eight COVID-19 vaccines were evaluated in Phase 3, 40 in Phase 2, 84 in Phase 1, and 199 in pre-clinical stages.

Dr. Jody Douglas Berry Joins NOWDiagnostics as Chief Scientific Officer

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목요일, 3월 14, 2024

NOWDiagnostics (NOWDx) today announced the appointment of Jody Douglas Berry, Ph.D. as chief scientific officer (CSO).

Key Points:

NOWDiagnostics (NOWDx) today announced the appointment of Jody Douglas Berry, Ph.D. as chief scientific officer (CSO).
Dr. Berry, a distinguished scientific leader with over two decades of experience in infectious diseases, brings a wealth of expertise in diagnostics and therapeutics to the role.
A recognized international expert in immunoassay development, antibody technology, and infectious diseases, Dr. Berry has over two decades of commercial, government and academic experience.
Dr. Berry earned international recognition for his contributions to immunoassay development, antibody technology, and protein design.

Cue Health Reports Fourth Quarter 2023 Financial Results

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수요일, 3월 13, 2024

Medical Devices, Infectious Diseases, Health, Health Technology, Telemedicine, Virtual Medicine, Telephone, COVID-19, RSV, GAAP, De novo, FDA, Video game

Cue Health Inc. ("Cue" or the “Company”) (Nasdaq: HLTH), a healthcare technology company, today reported financial results for the fourth quarter and full-year 2023.

Key Points:

Cue Health Inc. ("Cue" or the “Company”) (Nasdaq: HLTH), a healthcare technology company, today reported financial results for the fourth quarter and full-year 2023.
“We believe that these successes have positioned us well for 2024.”
Revenue was $18.8 million for the fourth quarter of 2023.
Adjusted operating costs and expenses were $48.3 million in the fourth quarter of 2023, a 49% decrease from $94.6 million in the fourth quarter of 2022.
Cue will host a conference call to discuss the fourth quarter and full year 2023 financial results, after market close on Wednesday, March 13, 2024, at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time.

Enhancing National Preparedness: Rafa Laboratories Partners with BARDA to Advance the Development of a new design for Rafa's Pediatric Atropine Autoinjectors

Retrieved on:

수요일, 3월 20, 2024

Development, Poisoning, Organophosphate, VX, Status epilepticus, Patient, Nerve agent, Clothing, Laboratory, Human services, Atropine, Sarin, Administration, FDA

Atropine - the primary antidote for nerve agent and insecticide poisoning, is usually administered via autoinjectors.

Key Points:

Atropine - the primary antidote for nerve agent and insecticide poisoning, is usually administered via autoinjectors.
Rafa Laboratories already manufactures adult atropine autoinjectors, FDA-approved in July 2018, and pediatric atropine autoinjectors authorized for use under FDA Emergency Use Authorization (EUA) in January 2018.
The new design for the pediatric atropine autoinjector, which is intended for civilian use, will incorporate a new needle shield mechanism feature.
To meet FDA approval requirements for the enhanced pediatric atropine autoinjector, BARDA will provide comprehensive support to Rafa Laboratories.

Enhancing National Preparedness: Rafa Laboratories Partners with BARDA to Advance the Development of a new design for Rafa's Pediatric Atropine Autoinjectors

Retrieved on:

수요일, 3월 20, 2024

Development, Poisoning, Organophosphate, VX, Status epilepticus, Patient, Nerve agent, Clothing, Laboratory, Human services, Atropine, Sarin, Administration, FDA

Atropine - the primary antidote for nerve agent and insecticide poisoning, is usually administered via autoinjectors.

Key Points:

Atropine - the primary antidote for nerve agent and insecticide poisoning, is usually administered via autoinjectors.
Rafa Laboratories already manufactures adult atropine autoinjectors, FDA-approved in July 2018, and pediatric atropine autoinjectors authorized for use under FDA Emergency Use Authorization (EUA) in January 2018.
The new design for the pediatric atropine autoinjector, which is intended for civilian use, will incorporate a new needle shield mechanism feature.
To meet FDA approval requirements for the enhanced pediatric atropine autoinjector, BARDA will provide comprehensive support to Rafa Laboratories.

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

Retrieved on:

목요일, 3월 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.