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- PMLiVE

regulatory decisions

- PMLiVE

EMA backs drugs from Novo, Otsuka, AZ, Janssen, GSK

Nine new branded medicines recommended for use in Europe

- PMLiVE

Boehringer’s first cancer drug leads EMA recommendations

Afatinib recommended for lung cancer under brand name Giotrif

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Pfizer and Otsuka face drug rejections in Europe

EMA turns down Xeljanz for rheumatoid arthritis and delamanid for tuberculosis

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GSK’s personalised cancer drug Tafinlar set for European approval

Regulatory advisors recommend the melanoma drug be licensed

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First mAb biosimilars set for European approval

Celltrion and Hospira's versions of J&J's blockbuster Remicade recommended by CHMP

- PMLiVE

EMA backs Pomalidomide Celgene in multiple myeloma

Further positive CHMP opinions for new medicines form Aegerion, Teva and more

- PMLiVE

GSK/ Valeant’s Trobalt set for EU restrictions

Eye concerns prompt CHMP to recommend last-line use for the epilepsy drug

- PMLiVE

Arena pulls obesity drug Belviq application in EU

EMA asks for more data

- PMLiVE

EMA refuses to back Pfizer’s Xeljanz in rheumatoid arthritis

Surprise after approvals in US and Japan

- PMLiVE

CHMP upholds rejection of Vivus’ obesity drug

Still no recommendation for Qsiva in Europe

- PMLiVE

Gentium expects EMA rejection for defibrotide

Negative feedback for drug’s use in liver condition associated with stem cell transplantation

- PMLiVE

Pfizer gets CHMP backing for leukaemia drug bosutinib

Provides option for patients resistant to tyrosine kinase inhibitors

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