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Black triangle monitoring warning to be used across EU

Use of symbol is part of EMA plans to strengthen pharmacovigilance

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Merck & Co’s sugammadex delayed in US

FDA says it needs more time to review application

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Vanda withdraws EU application for schizophrenia drug

CHMP had previously refused to back the approval of Fanaptum

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EMA’s Pharmacovigilance Risk Assessment Committee gains new members

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

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AbbVie sues EMA to block Humira data release

Pharma company seeks injunction following FOI requests for raw data

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Former Amgen R&D head Perlmutter to lead research at Merck & Co

Returns to US pharma firm after more than a decade away

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Novo’s Lantus rival Tresiba hits European markets

Company says its insulin degludec is a more flexible alternative to Sanofi's product

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Sanofi gets EMA backing for multi-disease vaccine in children

Hexyon-Hexacima 6-in-1 paediatric vaccine recommended for approval in Europe

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EMA application fees set for slower rise in 2013

European regulator expects rate to increase by 2.6 per cent

- PMLiVE

CHMP upholds rejection of Vivus’ obesity drug

Still no recommendation for Qsiva in Europe

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Gentium expects EMA rejection for defibrotide

Negative feedback for drug’s use in liver condition associated with stem cell transplantation

- PMLiVE

Merck to develop biosimilars with Samsung-Biogen joint venture

Agreement with Samsung Bioepis covers several candidates

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