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CHMP opinions

This page shows the latest CHMP opinions 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

58 mechanism, which gives the CHMP licence to assess and give opinions on medicines that are intended for use in countries outside the EU. ... The CHMP also gave its blessing to various line extensions for already-market drugs.

Latest news

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

    The drug should be used as when standard therapy desmopressin is ineffective or contra-indicated, according to the CHMP. ... In addition to the orphan drug approvals, the CHMP also gave positive opinions to Gruenenthal’s gout treatment Duzallo

  • CAR-Ts Kymriah and Yescarta step closer to approval in Europe CAR-Ts Kymriah and Yescarta step closer to approval in Europe

    The CHMP says it recommends adding this uses to its licensed indications, as it is would otherwise have to be used off-label, and is also obliging Novartis and Gilead to ... Reimbursement and new cell therapy infrastructure. The CHMP opinions will now

  • ViiV’s two-drug HIV combo backed by CHMP ViiV’s two-drug HIV combo backed by CHMP

    The CHMP opinion follows approval of Juluca by the FDA last November, which was brought forward after ViiV’s majority shareholder GlaxoSmithKline used an FDA priority review voucher purchased for $130m. ... There was bad news for three other companies,

  • Pfizer’s leukaemia drug Mylotarg backed for use in EU Pfizer’s leukaemia drug Mylotarg backed for use in EU

    The CHMP’s positive opinion could see the drug return to market after almost eight years. ... The CHMP also gave positive opinions to: a new maintenance indication for AstraZeneca and Merck &Co’s PARP inhibitor Lynparza (olaparib) in ovarian cancer;

  • Payback time nears as Sanofi gets CHMP backing for biosimilar Humalog Payback time nears as Sanofi gets CHMP backing for biosimilar Humalog

    Meanwhile among other positive opinions granted by the CHMP was one for Leo Pharma's interleukin-17 inhibitor Kyntheum (brodalumab) - acquired from AstraZeneca - for plaque psoriasis. ... The CHMP also backed three biosimilars of Roche's Rituxan

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  • NDA

    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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