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CHMP

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

CHMP backs Sanofi’s all-oral sleeping sickness drug

CHMP backs Sanofi’s all-oral sleeping sickness drug

CHMP backs Sanofi’ s all-oral sleeping sickness drug. Sanofi's drug and others given green light by EMA committee. ... The CHMP also gave its blessing to various line extensions for already-market drugs.

Latest news

  • Roche pulls EU Tecentriq/Avastin filing in kidney cancer Roche pulls EU Tecentriq/Avastin filing in kidney cancer

    Roche pulls EU Tecentriq/Avastin filing in kidney cancer. Another setback for Roche, but CHMP changes its mind on Opdivo/Yervoy. ... The EMA’s Committee for Medicinal Products for Human Use (CHMP) has said that Roche opted to withdraw the application

  • Shire’s angioedema drug Takhzyro recommended in Europe Shire’s angioedema drug Takhzyro recommended in Europe

    The European Medicines Agency's CHMP committee has recommended Shire’s Takhzyro (lanadelumab), a new rare disease treatment which has blockbuster potential. ... The CHMP decision is good news for Takeda, as there has been talk of revolt among some of

  • CHMP delays decision on Kiadis’ GVHD immunotherapy CHMP delays decision on Kiadis’ GVHD immunotherapy

    CHMP delays decision on Kiadis’ GVHD immunotherapy. Medicines regulator issues out Day 180 List of Outstanding Issues. ... Products for Human Use (CHMP), after the regulator issued a second round of outstanding issues.

  • New chair for Europe’s key medicines committee New chair for Europe’s key medicines committee

    Dr Harald Enzmann. Commenting on his appointment, Dr Enzmann said: “The CHMP is at the cutting edge of medical progress. ... The CHMP will elect a new vice-chair at its October 2018 meeting.

  • CHMP backs Spark’s Luxturna, but rejects Sarepta again CHMP backs Spark’s Luxturna, but rejects Sarepta again

    CHMP backs Spark’ s Luxturna, but rejects Sarepta again. Contrasting fortunes for rare disease treatments. ... therapies. The CHMP turned down Sarepta’s application for Exondys in May, but was asked to re-examine the evidence by the company.

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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 appointments

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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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