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- PMLiVE

Zydelig

- PMLiVE

Dismay as NICE turns down Afinitor for breast cancer

Patient groups say draft guidance is a major blow to women in England and Wales

- PMLiVE

Black triangle monitoring warning to be used across EU

Use of symbol is part of EMA plans to strengthen pharmacovigilance

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

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

Bayer fails to overturn Nexavar compulsory licence in India

Natco Pharma allowed to sell cut-price version of cancer drug

- PMLiVE

Roche gains EU approval for Perjeta in breast cancer

Available in combination with Herceptin and docetaxel chemotherapy

- PMLiVE

EMA application fees set for slower rise in 2013

European regulator expects rate to increase by 2.6 per cent

Roche - Basel

Roche’s Herceptin follow-up cleared in US

FDA approval for Kadcyla (formerly T-DM1) in breast cancer

- PMLiVE

Late-stage failure for Merck’s cilengitide in brain cancer

Integrin inhibitor unable to improve overall survival in phase III trials

- PMLiVE

CHMP upholds rejection of Vivus’ obesity drug

Still no recommendation for Qsiva in Europe

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