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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.

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

Latest news

  • 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

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

    ViiV’ s two-drug HIV combo backed by CHMP. The committee also backs two biosimilar medicines. ... There was bad news for three other companies, with the CHMP issuing negative opinions for Portola’s Dexxience (betrixaban) for the prevention of venous

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

  • 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

  • CHMP recommends Merck & Co's Lantus biosimilar CHMP recommends Merck & Co's Lantus biosimilar

    CHMP recommends Merck &Co's Lantus biosimilar. Also backs two biosimilar versions of Lilly’ s osteoporosis therapy Forteo. ... Forteo biosimilars. Meanwhile, the CHMP this month also issued positive opinions for two versions of Lilly's big-selling

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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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