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Novartis building

Novartis’ Zykadia claims US approval for first-line lung cancer

The Swiss pharma giant’s drug also receives CHMP positive opinion

- PMLiVE

Payback time nears as Sanofi gets CHMP backing for biosimilar Humalog

Panel recommends insulin Lispro Sanofi to treat diabetes

EU flag

CHMP backs two rare disease therapies at April meeting

Biogen's Spinraza and BioMarin's Brineura near EU approval

Actelion HQ Switzerland

EU nod for Actelion’s skin cancer drug Ledaga

Still need to meet CHMP post-approval requirements

- PMLiVE

J&J gets CHMP backing for broader Darzalex use

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

- PMLiVE

AZ nears EU approval for hyperkalaemia drug Lokelma

CHMP adopts positive opinion for the potassium-binding treatment

- PMLiVE

Marathon pauses Emflaza launch amid pricing furore

US Senator Bernie Sanders calls Duchenne muscular dystrophy drug’s pricing “unconscionable”

- PMLiVE

FDA approves first steroid for Duchenne muscular dystrophy

Marathon Pharma’s Emflaza is first approved to treat all genetic forms of the condition

- PMLiVE

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

- PMLiVE

Gilead’s hepatitis B virus treatment set for European approval

CHMP also recommends diabetes drugs from Sanofi and Novo Nordisk

- PMLiVE

CHMP recommends Merck & Co’s Lantus biosimilar

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

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