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FDA Takes Action on Updated mRNA COVID-19 Vaccines to Better Protect Against Currently Circulating Variants

Retrieved on: 
Monday, September 11, 2023

Individuals who receive an updated mRNA COVID-19 vaccine may experience similar side effects as those reported by individuals who previously received mRNA COVID-19 vaccines as described in the respective prescribing information or fact sheets.

Key Points: 
  • Individuals who receive an updated mRNA COVID-19 vaccine may experience similar side effects as those reported by individuals who previously received mRNA COVID-19 vaccines as described in the respective prescribing information or fact sheets.
  • The updated vaccines are expected to provide good protection against COVID-19 from the currently circulating variants.
  • Manufacturers have publicly announced that the updated vaccines would be ready this fall, and the FDA anticipates that the updated vaccines will be available in the near future.
  • This suggests that the vaccines are a good match for protecting against the currently circulating COVID-19 variants.

Invivyd Appoints William Duke as Chief Financial Officer

Retrieved on: 
Tuesday, September 5, 2023

WALTHAM, Mass., Sept. 05, 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 William Duke as Chief Financial Officer.

Key Points: 
  • WALTHAM, Mass., Sept. 05, 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 William Duke as Chief Financial Officer.
  • Mr. Duke will lead Invivyd’s financial strategy to support the company’s continued growth.
  • “With his demonstrated success leading initiatives that have fueled the advancement of novel therapeutics and led to significant value creation for shareholders, I’m thrilled to welcome Bill to our executive leadership team as we continue to rapidly advance our mission.”
    “I’m delighted to join Invivyd at such an exciting time for the company,” said William Duke, Chief Financial Officer of Invivyd.
  • Prior to Kaleido Biosciences, he was Chief Financial Officer of Pulmatrix, Inc., where he helped negotiate the company’s first product partnership and led the successful completion of several public offerings.

8 Key Trends in the $106 Billion Worldwide IVD Market

Retrieved on: 
Thursday, August 31, 2023

ARLINGTON, Va., Aug. 31, 2023 /PRNewswire/ -- In vitro diagnostics (IVDs) remain dynamic. The IVD market is a high R&D spend industry with constant innovations and routine interest from venture capital firms in diagnostic products.  Nevertheless, the past few years have been very disruptive for IVDs. However, the resilient IVD industry has weathered the pandemic and is forging ahead with new technologies and increased opportunities that will sustain market growth through the foreseeable future.

Key Points: 
  • The IVD market is a high R&D spend industry with constant innovations and routine interest from venture capital firms in diagnostic products.
  • The global IVD test market is estimated at $106 billion in 2023 and is expected to grow 3.8% annually through 2028.
  • This conclusion is among the analysis found in The Worldwide Market for In Vitro Diagnostic Tests, 16th Edition , the brand new market research report from leading firm Kalorama Information.
  • Beyond these developments, Kalorama Information emphasizes several other key trends that will shape the present and future of IVD testing.

Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron XBB.1.5-adapted COVID-19 Vaccine in the European Union

Retrieved on: 
Wednesday, August 30, 2023

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20230829323192/en/
    The European Commission (EC) will review the CHMP’s recommendation and is expected to make a final decision soon.
  • Following a decision from the EC, the updated vaccine will be ready to ship to applicable EU member states immediately.
  • “Omicron XBB-related sublineages are antigenically distant from prior Omicron strains and continue to account for the vast majority of COVID-19 cases globally.
  • Further, the application included pre-clinical data showing that the Omicron XBB.1.5-adapted monovalent COVID-19 vaccine generates a substantially improved response against multiple XBB sublineages, including XBB.1.5, XBB.1.16, and XBB.2.3, compared to the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine.

Novavax's Updated Protein-based XBB COVID Vaccine Induced Neutralizing Responses Against Emerging Subvariants, Including EG.5.1 and XBB.1.16.6

Retrieved on: 
Tuesday, August 22, 2023

Do not administer the Novavax COVID-19 Vaccine, Adjuvanted to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Novavax COVID-19 Vaccine, Adjuvanted.

Key Points: 
  • Do not administer the Novavax COVID-19 Vaccine, Adjuvanted to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Novavax COVID-19 Vaccine, Adjuvanted.
  • Altered Immunocompetence: Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Novavax COVID-19 Vaccine, Adjuvanted.
  • Limitations of Vaccine Effectiveness: The Novavax COVID-19 Vaccine, Adjuvanted may not protect all vaccine recipients.
  • The reports should include the words "Novavax COVID-19 Vaccine, Adjuvanted EUA" in the description section of the report.

Novavax's Updated Protein-based XBB COVID Vaccine Induced Neutralizing Responses Against Emerging Subvariants, Including EG.5.1 and XBB.1.16.6

Retrieved on: 
Tuesday, August 22, 2023

Do not administer the Novavax COVID-19 Vaccine, Adjuvanted to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Novavax COVID-19 Vaccine, Adjuvanted.

Key Points: 
  • Do not administer the Novavax COVID-19 Vaccine, Adjuvanted to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Novavax COVID-19 Vaccine, Adjuvanted.
  • Altered Immunocompetence: Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Novavax COVID-19 Vaccine, Adjuvanted.
  • Limitations of Vaccine Effectiveness: The Novavax COVID-19 Vaccine, Adjuvanted may not protect all vaccine recipients.
  • The reports should include the words "Novavax COVID-19 Vaccine, Adjuvanted EUA" in the description section of the report.

ExThera Medical Receives Certification for Medical Device Single Audit Program (MDSAP) and Recertification for International Organization for Standardization for Medical Devices (ISO 13485)

Retrieved on: 
Tuesday, August 15, 2023

ExThera Medical Corporation announces it has received simultaneous certification per Medical Device Single Audit Program (MDSAP) and International Organization for Standardization (ISO 13485) requirements.

Key Points: 
  • ExThera Medical Corporation announces it has received simultaneous certification per Medical Device Single Audit Program (MDSAP) and International Organization for Standardization (ISO 13485) requirements.
  • MDSAP certification confirms comprehensive achievement of regulatory audit requirements and compliance standards for medical device manufacturers looking to sell products within the United States (FDA), Canada (HC), Japan (MHLW), Australia (TGA), and Brazil (ANVISA).
  • MDSAP certification has the added benefit of potentially expediting the timetable to commercialization within these participating geographies.
  • The internationally recognized ISO 13485 certification further confirms achievement of medical device manufacturer quality standards requirements necessary for global market entry.

Invivyd Reports Second Quarter 2023 Financial Results and Business Highlights

Retrieved on: 
Thursday, August 10, 2023

ET

Key Points: 
  • ET
    WALTHAM, Mass, Aug. 10, 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 financial results for the quarter ended June 30, 2023, and recent business highlights.
  • “I am very excited with the progress we made in the second quarter.
  • Appointed Sara Cotter to board of directors: In July 2023, Invivyd appointed Sara Cotter to its board of directors.
  • Basic and diluted net loss per share was $0.46 for the quarter ended June 30, 2023, compared to $0.47 for the comparable period in 2022.

Cue Health Reports Second Quarter 2023 Financial Results

Retrieved on: 
Wednesday, August 9, 2023

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

Key Points: 
  • Cue Health Inc. ("Cue") (Nasdaq: HLTH), a healthcare technology company, today reported financial results for the second quarter 2023.
  • Submitted the Cue RSV Molecular Test as a De Novo submission to the FDA for at-home and point-of-care use during the second quarter.
  • These milestones, together with the early positive signs we’re seeing from Cue Lab and Cue Pharmacy, gives us optimism and confidence in the future of the Cue Health platform.”
    Revenue was $9.9 million for the second quarter of 2023.
  • GAAP net loss in second quarter of 2023 was $83.9 million and earnings per diluted share was a loss of $0.55 or an improvement of $0.12 from the second quarter of 2022.

United States DTC Wellness Testing Markets, Competition, Opportunity, and Forecast, 2018-2023 & 2023-2028F - ResearchAndMarkets.com

Retrieved on: 
Friday, August 4, 2023

The United States DTC Wellness Testing Market is expected to grow with an impressive CAGR in the forecast period 2024-2028.

Key Points: 
  • The United States DTC Wellness Testing Market is expected to grow with an impressive CAGR in the forecast period 2024-2028.
  • United States DTC Wellness Testing Market is growing on account of growing awareness among the population regarding DTC Wellness Testing, along with its benefits and consumer convenience related with it.
  • The growing awareness about wellness testing is creating a huge demand for the DTC Wellness testing market among the population in case of rising demand for DTC wellness Testing offerings such as home health & wellness kits.
  • Company Profiles: Detailed analysis of the major companies present in United States DTC Wellness Testing Market.