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Sanofi reception

Follow-up data suggests long-term benefit of Sanofi’s Lemtrada in MS

Drug has a durable effect on relapse rates and disability progression

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Merck & Co’s sugammadex delayed in US

FDA says it needs more time to review application

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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

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FDA explains draft Alzheimer’s guidance in NEJM editorial

Intends to relax requirements in patient function and cognition

FDA smartphone regulation could stifle innovation

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

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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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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

Search appears on FDA’s radar once again

Warning letter to Florida company puts new slant on regulator's digital focus

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GSK’s COPD drug Anoro under review in US

FDA accepts new drug application for the LAMA/LABA combination

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