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Wakix backed for European approval in narcolepsy

Bioprojet Pharma’s orphan drug given a positive opinion by CHMP

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EMA review clears GSK and Sanofi Pasteur MSD HPV vaccines

Concludes Cervarix andGardasil don’t cause CRPS or POTS

- PMLiVE

Consultation begins on new patient access scheme

EMA hopes PRIME will improve development of prioritymedicines and ease access concerns

- PMLiVE

Amgen’s Imlygic recommended for European approval

First-in-class oncolytic immunotherapy wins CHMP positive opinion

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CHMP October meeting gives recommendations for Pfizer and MSD

But the regulatory advisors sound note ofcaution on Biogen’s Tecfidera

- PMLiVE

Novartis’ Cosentyx on course for new European indications

CHMP recommends its approval to treat ankylosing spondylitis and psoriatic arthritis

- PMLiVE

Guido Rasi set for return as EMA executive director

Regulator's board nominates him to resume hisleadership role

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CHMP recommends 19 new medicines for European approval

Praxbind and Entresto - both fast-tracked - among those to be backed

- PMLiVE

Amgen’s Kyprolis and Blincyto on track for European approval

Double CHMP recommendation backs the myeloma and leukaemia drugs

- PMLiVE

CHMP backs GSK’s asthma antibody and Novartis’ heart failure drug

Positive opinions for GSK's IL-5 antibody and Novartis' potential $5bn-a-year brand

- PMLiVE

Dr June Raine continues as chair of EMA’s pharmacovigilance committee

The PRAC also voted to extend Dr Almath Spooner's tenure asvice-chair

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BMS’ HIV combination Evotaz cleared in Europe

Comes after the firm recently announced it would shelve much of its virology unit

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