Pharma R&D Today

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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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New studies question what we thought we knew about aspirin

Posted on December 17th, 2019 by in Chemistry

For decades, aspirin (acetylsalicylic acid) has been viewed as something of a wonder drug. A staple in most households, people have turned to it for everything from headache relief to heart attack prevention. However, recent studies have raised some serious questions about the benefits of regular aspirin usage.

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FDA collaborates with Elsevier on drug-induced liver injury (DILI) tool

Posted on December 3rd, 2019 by in Pharma R&D

A leading cause of attrition of compounds in drug development, drug-induced liver injury (DILI) is also one of the top causes of drug withdrawals, restrictions and project terminations. DILI results when reactive metabolites – formed when certain orally administered drugs are metabolized in the liver – end up binding to cellular proteins and damaging liver cells.

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Government Shutdown Means New Drugs May Have to Wait – But Safety Monitoring Will Continue

Posted on January 17th, 2019 by in Pharma R&D

The partial shutdown of the U.S. government, which began just before the Christmas holiday, has been especially terrible for hundreds of thousands of federal employees who are either furloughed or working without pay. (more…)

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