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- PMLiVE

Protelos

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CHMP backs Xolair for severe hives

Novartis set to expand indications for asthma drug

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Daiichi files new anticoagulant edoxaban in US and EU

Seeks approvals in atrial fibrillation and venous thromboembolism

- PMLiVE

European Court may yet force AbbVie and InterMune to release data

Orders rethink on EMA's Humira and Esbriet injunction

- PMLiVE

Pfizer ups the ante on clinical transparency

Revamps access to data portal

- PMLiVE

EMA: more fee reductions for orphan drugs

Greater incentives introduced for larger companies

- PMLiVE

BMS/AZ’s diabetes drug among CHMP recommendations

Xigduo one of six new drugs backed in EU

- PMLiVE

Ariad’s cancer drug to remain on EU market

But EMA restricts use of Iclusig due to blood clot risk

- PMLiVE

CHMP recommends Gilead’s sofosbuvir for hep C

Set to be first interferon-free treatment regime

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EMA drug data to address HTA needs

EU regulator agrees joint work plan with EUnetHTA

- PMLiVE

EMA warns of excessive caution by regulators

Agency says risk aversion could deny patients new treatments

- PMLiVE

EMA to review safety of Ariad’s Iclusig

Product information will be updated to warn of blood clot risk

- PMLiVE

EMA on track with biosimilars guidance says industry

Updates expected to build confidence among healthcare professionals and patients

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