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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

Shire acquires Swiss biotech Premacure

Gains phase II eye drug for rare infant condition

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

Bupa swipes Shire’s SVP of global commercial operations

Theresa Heggie joins as chief strategy and marketing officer

- PMLiVE

Pfizer drops hepatitis C candidate filibuvir

Compound was lagging behind investigational drugs from Gilead and AbbVie

- PMLiVE

Takeda files IBD drug vedolizumab in Europe

Potential safer alternative to TNF blockers like Remicade and Humira

- PMLiVE

Pfizer sues as Celebrex patent is reissued in US

Court extends exclusivity of osteoarthritis treatment by 18 months

- PMLiVE

NICE recommends BMS-Pfizer’s Eliquis to prevent stroke

Joins Xarelto and Pradaxa anticoagulants as potential warfarin replacement

- PMLiVE

Second approval in US for Bayer-Onyx’ Stivarga

FDA clears drug to treat patients with gastrointestinal stromal tumours

Roche - Basel

Roche’s Herceptin follow-up cleared in US

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

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