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- PMLiVE

Gaucher disease

- PMLiVE

Otsuka’s Pletal has use restricted in Europe

EMA recommends drug only be used in limited group of patients with blood supply disorder

- PMLiVE

Black triangle monitoring warning to be used across EU

Use of symbol is part of EMA plans to strengthen pharmacovigilance

- PMLiVE

Merck & Co’s sugammadex delayed in US

FDA says it needs more time to review application

- PMLiVE

FDA investigates pancreas risk of diabetes drugs

Products from Merck & Co, BMS, AZ, Novo Nordisk, Boehringer, Amylin and Takeda all involved

Novartis building

FDA deems Novartis lung cancer drug a “breakthrough therapy”

LDK378 will have accelerated passage through development

- PMLiVE

Vanda withdraws EU application for schizophrenia drug

CHMP had previously refused to back the approval of Fanaptum

- PMLiVE

FDA explains draft Alzheimer’s guidance in NEJM editorial

Intends to relax requirements in patient function and cognition

FDA smartphone regulation could stifle innovation

US House Republicans issue warning on guidance and call for more information

- PMLiVE

EMA’s Pharmacovigilance Risk Assessment Committee gains new members

Filip Babylon to represent HCP organisations and Albert van der Zeijden to represent patient organisations

- PMLiVE

AbbVie sues EMA to block Humira data release

Pharma company seeks injunction following FOI requests for raw data

- PMLiVE

Second approval in US for Bayer-Onyx’ Stivarga

FDA clears drug to treat patients with gastrointestinal stromal tumours

- PMLiVE

EMA application fees set for slower rise in 2013

European regulator expects rate to increase by 2.6 per cent

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