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- PMLiVE

EMA

- 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

- PMLiVE

The future of market access through a communications lens

Communications will play a pivotal role in helping pharma to define the value agenda

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

EISAI

Eisai “appalled” at decision not to recommend Fycompa in Germany

Regulator says pharma company filed inadequate comparison data for its epilepsy drug

- 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

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