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MeMed’s Sepsis Severity Test Gets FDA Breakthrough Device Designation

XTalks

The test builds upon the MeMed BV test, which received FDA clearance in July 2023 and a CE marking under the European In Vitro Diagnostic Devices Regulation (IVDR) in the European Union (EU). Its the first FDA-cleared host-immune response assay for accurately distinguishing between bacterial and viral infections in just 15 minutes.

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Ixchiq Wins FDA Approval as World’s First Chikungunya Vaccine

XTalks

Valneva recently reported that it has been experiencing an increase in sales of its other vaccines due to the “recovery of the travel industry.” It appears the company has already done so as its quarterly earnings report included $96 million and $117 million of additional revenue from the sale of the PRV in its 2023 revenue guidance.

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2021 Biotech IPOs Get Off to a Roaring Start

The Pharma Data

Ortho Clinical Diagnostics is a leader in in vitro diagnostics. On January 12, its VITROS SARS-CoV-2 Antigen Test for mass-scale COVID-19 testing received FDA Emergency Use Authorization. The year is starting off with a number of biopharma and life sciences initial public offerings (IPOs). TCR2 Therapeutics – The Cambridge, Mass.

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Roche launches new quantitative antibody test to measure SARS-CoV-2 antibodies, to support the evaluation of vaccines

The Pharma Data

The Elecsys Anti-SARS-CoV-2 serology test can be used to quantitatively measure antibodies in people who have been exposed to the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and can play an important part in characterising a vaccine-induced immune response. The test targets antibodies against the spike protein.

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AZD7442 PROVENT Phase III prophylaxis trial met primary endpoint in.

The Pharma Data

More than 75% of participants had co-morbidities, which include conditions that have been reported to cause a reduced immune response to vaccination. The trial accrued 25 cases of symptomatic COVID-19 at the primary analysis.There were no cases of severe COVID-19 or COVID-19-related deaths in those treated with AZD7442.

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Roche’s Tecentriq approved by European Commission as a first-line monotherapy treatment for people with a type of metastatic non-small cell lung cancer

The Pharma Data

Tecentriq significantly improved overall survival in people with high PD-L1 expression, compared with chemotherapy in a Phase III study. Tecentriq approval offers an alternative to chemotherapy for all eligible patients. We are delighted to bring Tecentriq to people in the EU with this specific type of lung cancer,” said Levi Garraway, M.D.,

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COVID-19 Pandemic Coverage

XTalks

Tension is mounting as nations big and small jockey around industry to ensure they are first in line to access a vaccine, should one prove to be successful against COVID-19. By the end of August, the World Health Organization (WHO) counted 33 vaccine candidates in some stage of clinical trial evaluation. The price of that prize is incalculable.

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