Pharma R&D Today

Ideas and Insight supporting all stages of Drug Discovery & Development

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5 Ways RWE is Fueling the Fight Against COVID-19

Posted on June 19th, 2020 by in COVID-19

As we discussed in an earlier blog post, real-world evidence can bring value to every stage of the drug life cycle, from early discovery to post-market. Now, as the worldwide research community continues to battle the COVID-19 pandemic, we are also discovering how real-world data and real-world evidence have something to offer in these efforts as well.

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How Are Regulatory Agencies Reacting to the Use of Real-World Evidence?

Posted on June 15th, 2020 by in Pharma R&D

As we have discussed here previously, real-world data (RWD) and real-world evidence (RWE) offer many potential benefits in every stage of the drug discovery and development process, continuing on into post-market surveillance. With drug developers and other researchers becoming more interested in using RWD and the RWE that results from analyzing it, regulatory agencies have had to step up and work on producing guidance.

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Drug Repurposing for SARS-CoV-2 Using Network Polypharmacological Approach

Posted on June 9th, 2020 by in COVID-19

Drug development is a multidisciplinary field that requires a drug to successfully pass through different stages — from chemical design to biological experimentation on cells and animals, and finally three phases of human clinical trials — before being approved by the FDA for clinical administration. However, following such a path would not be feasible under circumstances where rapid discoveries are required, such as in the case of the current SARS-CoV-2 outbreak. Hence, repurpose of already approved FDA drugs could help in such circumstances, which can save effort, time and money.

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FDA report shows 2019 was a strong year for innovation

Posted on February 10th, 2020 by in Pharma R&D

Source: FDA.gov

On January 2, 2020, the FDA released the CDER annual report, stating that 2019 was “another strong year for innovation and advances.” The FDA cleared 48 new drugs for market, making it the second most productive year in the last decade (2018 approved 59 drugs). But given the fact that the total number of submissions have gone down, and that the American government was shut down for a lengthy period at the beginning of the year, the FDA delivered an impressive result in 2019.

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