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Phase 3 trial data confirm efficacy and safety profile of R21/Matrix-M malaria vaccine in African children

Express Pharma

Phase 3 trial data results of The R21/Matrix-M vaccine developed by Oxford University and Serum Institute of India, leveraging Novavax’s Matrix-M adjuvant has confirmed high efficacy and supported regulatory approvals and licensure in several African countries. No other vaccine has reported over 55 per cent efficacy in the same age group.

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Data hackathon analyses truth behind TB vaccine and COVID-19

pharmaphorum

Is a century-old vaccine a ‘game-changer’ for COVID-19? This is especially true in the search for effective therapies to fight COVID-19, and a vaccine. In a worst-case scenario, misplaced hype could lead to a sudden rush to buy doses of the BCG vaccine. Understanding the link between COVID-19 and the BCG vaccine.

Vaccines 110
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Russia asks for “non-political” treatment of Sputnik V shot, then rules out US filing

pharmaphorum

The state-owned backers of Russia’s Sputnik V coronavirus vaccine have ruled out a US filing, as talks began in earnest with European regulators over a review. said an RDIF spokesperson when pharmaphorum asked if there were plans to file the vaccine developed by the Gamaleya Research Institute with the FDA. Why should we?”

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Examining COVID’s impact on clinical research participant diversity

pharmaphorum

A study of FDA-approved vaccine trials from 2011-2020 showed that 78% of participants were white, even though only 60% of the U.S. Twenty-three percent fewer clinical trials were launched from March through May 2020 because of the pandemic, and many clinical researchers switched to focusing on COVID-19 vaccines and treatments.

Vaccines 111
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Understanding the evidence used in drug product withdrawals

European Pharmaceutical Review

Between 1999 and 2001, it supported 17 percent of withdrawals, between 2002 and 2011, it supported 26 percent of withdrawals and by 2012 to 2016, 80 percent of withdrawals were supported by observational studies (cohort, case-control, or other epidemiologic design). Meta-analyses contributed least frequently (31.4 EMA/95098/2010.

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Targovax announces plans to rebrand as Circio

Pharmaceutical Technology

Initially reported in 2011, CircRNA is a naturally occurring class of RNA. Circio aims to develop new circRNA medicines initially for cancer, then plans to expand rapidly into vaccines and gene therapy. In addition to new regulatory functionalities, this feature may result in stronger and more durable protein expression.

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Pfizer vaults into sickle cell market as GBT deal confirmed

pharmaphorum

In 2011 it paid $340 million for rights to rivipansel , a pan-selectin antagonist developed by GlycoMimetics, which failed a phase 3 test in 2019 and was jettisoned by Pfizer the following year. It’s worth noting that this isn’t Pfizer’s first deal in SCD.

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