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EMA CHMP recommends authorisation of AstraZeneca’s Evusheld for Covid-19

Pharmaceutical Technology

The EMA CHMP positive opinion is based on findings from the double-blind, randomised, placebo-controlled, multicentre Phase III TACKLE clinical trial of IM dose of Evusheld. Additionally, in the trial, the antibody cocktail was found to be well-tolerated. 5 variant, the company noted.

In-Vitro 279
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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 new Elecsys Anti-SARS-CoV-2 S test can quantitatively measure the level of antibodies against SARS-CoV-2 in patients who have been exposed to the virus. The test targets antibodies against the spike protein. This is the focus of vaccines in development and convalescent plasma therapy.

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Ixchiq Wins FDA Approval as World’s First Chikungunya Vaccine

XTalks

France-based biotech Valneva has won approval from the US Food and Drug Administration (FDA) for its chikungunya vaccine Ixchiq for the prevention of infection from the chikungunya virus. The vaccine is approved for adults 18 years of age and older who are at increased risk of exposure to the virus.

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Pfizer/BioNTech COVID-19 Vaccine Trial Results: Stellar, Long-Ranging Efficacies in Children and Against Variants

XTalks

Pfizer released new COVID-19 vaccine trial results this week from its ongoing clinical studies, which include data showing that its COVID-19 mRNA vaccine is 100 percent effective in children between the ages of 12 and 15 and has a 91 percent efficacy against variants with protection lasting at least six months.

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COVID-19 Vaccine Messaging: Why Vaccine Efficacies Can’t Be Compared and Shopped

XTalks

As the US Food and Drug Administration (FDA) handed out an emergency use authorization (EUA) to Janssen’s COVID-19 vaccine over the weekend — making it the third authorized COVID-19 vaccine in the US — many people became laser-focused on the 66 percent average efficacy of the single-dose shot.

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Pfizer/BioNTech Begin Studies for Third Booster Dose and Development of COVID-19 Vaccine Variants

XTalks

(NYSE: PFE ) and BioNTech SE (Nasdaq: BNTX ) have announced that they are beginning a trial to evaluate the safety and efficacy of a third booster dose for their COVID-19 vaccine (BNT162b2), as well as new vaccine variants. The study will be a part of current Phase I, II and III trials.

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CohBar and Morphogenesis in merger for immuno-oncology therapies

Pharmaceutical Technology

Morphogenesis’s technologies include Immune Fx (IFx) personalised cancer vaccines and tumour microenvironment (TME) modulators. Morphogenesis’ lead personalised cancer vaccine, IFx-Hu2.0, is expected to enter Phase II/III registration trial as the first-line treatment for advanced Merkel cell carcinoma (MCC) early next year.