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- PMLiVE

regulatory decisions

- PMLiVE

J&J gets CHMP backing for broader Darzalex use

Recommendation for earlier-stage approval could see multiple myeloma drug reach blockbuster sales

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AZ nears EU approval for hyperkalaemia drug Lokelma

CHMP adopts positive opinion for the potassium-binding treatment

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Amgen’s Humira biosimilars backed for EU approval

Amgevita and Solymbic prepare to challenge AbbVie’s blockbuster

Eli Lilly HQ

Lilly nears EU approval of arthritis drug baricitinib

On course for early 2017 verdict, setting up challenge to Pfizer’s Xeljanz

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Gilead’s hepatitis B virus treatment set for European approval

CHMP also recommends diabetes drugs from Sanofi and Novo Nordisk

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CHMP recommends Merck & Co’s Lantus biosimilar

Also backs two biosimilar versions of Lilly’s osteoporosis therapy Forteo

Eli Lilly HQ

Lilly bags EU approval for cancer treatment Lartruvo

Licensed for use with doxorubicin for soft tissue sarcoma patients

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CHMP backs Intercept’s rare liver disease drug

Ocaliva on track for EU approval as analysts predict blockbuster sales

Roche Basel Switzerland

AbbVie and Roche’s leukaemia drug venetoclax nears EU market

CHMP grants blood cancer treatment Venclyxto a conditional green light

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Lilly closes on first approval for sarcoma drug Lartruvo

Orphan drug improved patient survival time by almost 12 months in phase II trial

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HIV prevention pill heads July CHMP recommendations

Gilead’s Truvada given positive opinion alongside Ipsen Pharma’s Cabometyx and Eisai’s Kisplyx

Roche Basel Switzerland

Roche’s MS drug Ocrevus awarded priority review by FDA

Comes as Swiss company files the therapy with the FDA and EMA

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