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EISAI

Eisai’s thyroid cancer drug Lenvima nears EU approval

Positive recommendation by the CHMP could see the orphan drug used in Europe within three months

- PMLiVE

EMA elects Dr Christa Wirthumer-Hoche new vice chair

Head of the Austrian regulator succeeds Prof DrWalter Schwerdtfeger

- PMLiVE

Lilly/Boehringer’s diabetes combination Glyxambi debuts in US

Companieslaunch first fixed-dose of empagliflozin and linagliptin

- PMLiVE

Takeda’s Entyvio recommended by NICE for bowel disease

But must supply the drug at a discounted rate to the NHS

EU flag

New cancer meds and drug extensions top CHMP recommendations

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

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

Gilead Sciences

Gilead’s Sovaldi wins NICE approval but faces access delay

The Institute also recommends Janssen's hepatitis C drug Olysio

EU flag

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

- PMLiVE

Abraxane on course for lung cancer indication in EU

CHMP backs news indication for Celgene drug

- PMLiVE

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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