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CHMP

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

Alnylam gets EU nod for Onpattro amid pricing backlash

Alnylam gets EU nod for Onpattro amid pricing backlash

The EU approval follows a positive recommendation from the EMA’s Committee for Medicinal Products for Human Use (CHMP), and is based on the APOLLO study, in which patients given an

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Latest Intelligence

  • The European Medicines Agency: PRIME’d for access? The European Medicines Agency: PRIME’d for access?

    Early signs are looking good: Novartis’Kymriah (tisagenlecleucel) and Gilead/Kite’s Yescarta (axicabtagene ciloleucel) secured positive opinions from EMA's Committee for Medicinal Products for Human Use (CHMP) in June

  • 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

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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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