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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 Bayer’s tumour-agnostic drug Vitrakvi

CHMP backs Bayer’s tumour-agnostic drug Vitrakvi

The EMA’s human medicines committee (CHMP) has backed a conditional approval of Vitrakvi (larotrectinib) for the treatment of solid tumours with a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. ... There were two other positive opinions on

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  • 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.

  • 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;

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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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