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CHMP

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

Takeda’s Alofisel becomes Europe’s first allogeneic stem cell therapy

Takeda’s Alofisel becomes Europe’s first allogeneic stem cell therapy

The European approval follows a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) last December, which gave its recommendation based on results from ADMIRE-CD,

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Latest Intelligence

  • 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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Meet the CEO behind ReNeuron’s cutting-edge stem cell therapies
Blue Latitude Health speaks to Olav Hellebo, CEO of ReNeuron, to find out about the biotech’s latest innovation in stem cell therapy and to learn his perspective on navigating the...

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