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FDA approves first biosimilar

Novartis’ Sandoz unit gains new licence for Neupogen copycat

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New cancer meds and drug extensions top CHMP recommendations

Drugs for rare disease, oncology and diabetes top regulator’s endorsements

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Amgen’s Kyprolis tops Velcade in myeloma trial

Amgen hoping to topple Takeda’s $2bn a year drug

Sanofi reception

Sanofi’s Lantus follow-up nears European approval

CHMP backing for Toujeo follows hot on the heels of its US approval by the FDA

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Jinarc backed for European approval in rare kidney disease

Positive opinion for Otsuka comes just before rare disease awareness day

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EMA defends Humira redaction policy from transparency criticism

Regulator says spirit of trial transparency intact after its handling of AbbVie reports

Gathering pace: adaptive pathways

EMA looks at how the model could work in practice and picks first drugs for its pilot project

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Amgen banking on three launches in 2015

New products on the way for cholesterol, heart failure and melanoma

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Abraxane on course for lung cancer indication in EU

CHMP backs news indication for Celgene drug

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Indian generics firm GVK set to be hit with European sales ban

EU regulator raises concerns on conduct of drug studies in India

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Antibiotics among 7 new drugs backed by EMA

The Medicines Company’s Orbactiv and Cubist’s Sivextro set for European approval

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AZ files gout drug lesinurad in Europe

Acquired drug as part of its takeover of Ardea Biosciences in 2012

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