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Unlocking the mRNA Platform Technology: Walking the Talk with Investment Protection

Bill of Health

By Aparajita Lath Two articles published last month in the BMJ analyze the public investment and financing of mRNA COVID-19 vaccines, highlighting the extensive government funding that has supported the development of mRNA technology from 1985 to 2022. government substantially de-risking the vaccine development process.

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SQA Regulatory Surveillance Summary 4 | Monthly Update 2021

SQA

ANVISA released on 05 March the report Regulation in Numbers , presenting the 2020 actions aiming to improve the regulatory quality of the Agency. Backgrounder – Government of Canada Investments in Biomanufacturing, Development of COVID-19 Vaccines and Therapeutics, and Research, 18 May 2021. National Research Council.

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The Healthcare and Macro-Economic Impacts of Living with Endemic COVID – Listening to Fitch

Health Populi

On the pharma supply side, mRNA vaccines will dominate the market, proving more effective than others at stemming a further outbreak. With growing global supply and competition, we can expect prices for COVID-19 vaccines to fall, anticipating additional volumes from Sinopharm, Moderna, Sinovac, Gamaleya Institute, among others.

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SQA News | Spring 2021

SQA

Even with more of the world receiving their Covid-19 vaccinations, there are some countries lagging behind or dealing with a different strain. These continued hurdles are met with passion to succeed from SQA clients producing more vaccines to increase supply, and other options to fight Covid-19. Challenges.

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3 Lessons Learned from Pandemic-Era Clinical Development Regulatory Practices

HIT Consultant

The world has been in urgent need of COVID-19 vaccines, treatments, and diagnostic tools. The rapid adoption of decentralized and hybrid clinical study design spurred by the pandemic will present new regulatory challenges for the foreseeable future. Ronan Brown, SVP and Head of Integrated Global Compliance, IQVIA.

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SQA Regulatory Surveillance Summary 2 | Monthly Update 2021

SQA

The concepts presented in PDA Technical Report No. United States Food and Drug Administration (FDA) – Regulations and Guidances for Biologics and the Bioresearch Monitoring Program (BIMO). Coronavirus (COVID-19) Update: FDA Issues Policies to Guide Medical Product Developers Addressing SARS-CoV-2 Virus Variants, 22 February 2021.

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A Timeline of Biden’s Pandemic Response, Part 3: We Have the Tools (Sept. – Dec. 2021)

Bill of Health

The American booster push was controversial, because the scientific evidence on the need for and effectiveness of boosters was limited, and the White House exerted an unprecedented level of pressure on the FDA and CDC’s ‘independent’ scientific review processes. Ultimately, both the FDA and CDC gave their blessing to boosters.