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This page shows the latest CRL news and features for those working in and with pharma, biotech and healthcare.

New trial data for Keytruda in triple-negative breast cancer

New trial data for Keytruda in triple-negative breast cancer

In March 2021, the US Food and Drug Administration (FDA) issued Merck &Co a complete response letter (CRL) rejecting a supplemental biologics licence application (sBLA) in TNBC, based on the pCR

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  • Shanks v Unilever? Or David v Goliath? Shanks v Unilever? Or David v Goliath?

    The facts. Professor Shanks was employed as an inventor by a subsidiary of Unilever called Central Resources Limited (CRL). ... In comparison with CRL, Professor Shanks’ invention was of sufficient benefit to award him compensation.

  • Europe vs the US: New drug product approvals Europe vs the US: New drug product approvals

    During 2016 the FDA issued 14 CRLs, compared to just two in 2015. ... Failure of manufacturing facilities to pass FDA inspection can unnecessarily delay patient access to novel new drugs.” The increase of CRLs seen in 2016 indicates that the use of

  • Deal Watch May 2016 Deal Watch May 2016

    The CRL refers to a manufacturing issue. ZS-9 was acquired when the company purchased ZS Pharma for $2.7bn. ... The manufacturing CRLs have been out in force and AstraZeneca is not the only company on the receiving end with OPKO receiving a CRL earlier

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