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CHMP

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

Sanofi’s rare blood disorder drug Cablivi set for European approval

Sanofi’s rare blood disorder drug Cablivi set for European approval

Among the other recommendations, Ultragenyx picked up a positive CHMP opinion for its mucopolysaccharidosis type VII drug – Mepsevii (vestronidase alfa) – which was approved in the US last November. ... The drug should be used as when standard

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  • Deal Watch January 2018

    In December 2017, the CHMP of the EMA gave a positive opinion recommending a marketing authorisation for Cx601, so it was probably a good time for Takeda to make a move.

  • Drug safety

    Healthcare terms - Drug safety.

  • Drug R&D

    Healthcare terms - Drug R&D.

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

    In the US, five biosimilars were approved in 2016. In the EU, eight new approvals for biosimilars were recommended for approval by the CHMP in 2016; four of these were still

  • The pill branding The pill branding

    After long discussions between politicians in the respective countries about its safety, and after the CHMP's (EMA Committee for Medicinal Products for Human Use) recommendation, the European Commission finally made

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Latest from PMHub

  • Wordbird helps ellaOne® fly over the counter

    In addition, Wordbird has provided consultancy in responding to CHMP questions during the reclassification process.

  • NDA

    Year on year, NDA has contributed towards more than 30% of new medicinal products receiving CHMP opinions, through strategic advice and operational support.

  • Research and development

    Year on year, NDA has contributed towards more than 30% of new medicinal products receiving CHMP opinions, through strategic advice and operational support.

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Merrill Brink International

Merrill Brink International is a leading provider of life sciences, legal, financial, manufacturing and corporate language solutions for global companies....

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Many people in the pharma industry still aren’t following the rules set out by the GDPR when it comes to running events and attending tradeshows. But with eye-watering fines for...
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The modern approach to B2B sales is data-driven, and enabled by digital tools....

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