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breakthrough therapy

Novartis building

Novartis, ThromboGenics’ eye drug Jetrea gets green light in EU

First drug specifically approved for vitreomacular adhesion

- 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

FDA explains draft Alzheimer’s guidance in NEJM editorial

Intends to relax requirements in patient function and cognition

- PMLiVE

Informatics to drive clinical trials in UK

Scotland’s chief scientist says NHS data can support medicines research

FDA smartphone regulation could stifle innovation

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

- PMLiVE

Former Pfizer VP James Taylor joins INC Research

He was previously VP global clinical trial management at the US pharma firm

- PMLiVE

Pfizer drops hepatitis C candidate filibuvir

Compound was lagging behind investigational drugs from Gilead and AbbVie

- PMLiVE

Pfizer sues as Celebrex patent is reissued in US

Court extends exclusivity of osteoarthritis treatment by 18 months

- PMLiVE

Bayer fails to overturn Nexavar compulsory licence in India

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

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