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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.

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

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  • 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

  • Gilead, Merck get CHMP backing for new hep C combinations Gilead, Merck get CHMP backing for new hep C combinations

    Gilead, Merck get CHMP backing for new hep C combinations. Approval of Epclusa and Zepatier will see the pan-genotypic drugs compete for market share. ... Gilead Sciences and Merck Sharp &Dohme (MSD) both bagged CHMP positive opinions for two-drug,

  • GSK gene therapy tops CHMP recommendations GSK gene therapy tops CHMP recommendations

    GSK gene therapy tops CHMP recommendations. ADA-SCID treatment Strimvelis set for European approval. ... Other decisions. Other positive opinions adopted by the CHMP included a conditional marketing authorisation for Darzalex (daratumumab),

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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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