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- PMLiVE

Cyltezo

- PMLiVE

AbbVie said to be planning major salesforce cuts in US

Follows loss of patent protection for TriCor and Niaspan

- PMLiVE

FDA approves return of morning sickness drug for pregnant women

Regulator confirms safety of Diclegis – formerly known as Bendectin

Unfolding the biosimilar landscape in Latin America

Cost containment and safety concerns mean an ongoing tussle between payers and regulators, with the latter gaining the upper hand

- PMLiVE

Current development and marketing of biosimilar monoclonal antibodies in Latin America

An in-depth table of biosimilar products in the region

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Bayer’s riociguat fast-tracked by FDA

Could provide oral option in pulmonary arterial hypertension market

- PMLiVE

FDA delays GlaxoSmithKline’s pandemic flu vaccine

More time needed due to "administrative" issue

FDA says final mobile app guidance just weeks away

And tells Congress only a fraction of mobile apps will need regulating

- 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

ACC and Boehringer develop CME programme in China

Will focus on stroke prevention in atrial fibrillation

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