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

EU authorises Aimmune’s peanut allergy treatment Palforzia

EU authorises Aimmune’s peanut allergy treatment Palforzia

In August, DBV announced that it had received a complete response letter (CRL) from the US Food and Drug Administration (FDA) for its Viaskin peanut allergy treatment.

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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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PMEA Awards 2020

COVID-19 Updates and Daily News

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Attigo (part of the Mednet Group)

Inclusion drives innovation. Attigo, a social enterprise, helps pharma and the socially conscious business shape the future by engaging with...

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PME Jan cover
AstraZeneca’s focus on diagnosing and managing chronic kidney disease
People living with chronic kidney disease are in urgent need of new and improved approaches to diagnosis and care...
Delphi Technique Virtual Co-creation: A Customer Story
How a client leveraged the Delphi technique to co-create a consensus statement and algorithm using virtual touchpoints....
AI healthcare
Three ways AI will change healthcare in the next decade
Looking forward, there is no doubt that AI will continue to take centre stage in global healthcare initiatives...