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Pradaxa

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FDA gives priority review status to BMS/ AZ’s metreleptin

Former obesity prospect has potential in the rare disease lipodystrophy

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ASCO: Boehringer’s nintedanib boosts survival in lung cancer subset

Trial date demonstrates benefit in NSCLC patients with adenocarcinomas

Sanofi reception

Sanofi gives up on iniparib and otamixaban

Drops cancer drug and anticoagulant after negative late-stage trials

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FDA clears two GSK melanoma drugs

Tafinlar and Mekinist approved in the US along with companion diagnostic

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FDA gives Alexion’s metabolic drug breakthrough status

Reduces requirements for registration, potentially speeding up approval

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Bayer wins EU approval for Xarelto in ACS

Comes despite US FDA decision not to recommend extra indication for anticoagulant

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US FDA approves Roche’s assay as first blood test to diagnose diabetes

Will help catch diabetes early in country where seven million people are undiagnosed

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Merck & Co inches closer to US green light for insomnia drug

FDA panel backs suvorexant, although some concerns about high dosages

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Boehringer’s Wolfram Carius to step down

He will be replaced by Wolfgang Baiker on the board of managing directors

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J&J’s Simponi wins FDA approval in ulcerative colitis

Adds to rheumatoid arthritis, psoriatic arthritis and active ankylosing spondylitis indications in the US

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FDA clears Bayer/ Algeta’s prostate cancer radiotherapy

Approval for Xofigo comes three months ahead of schedule

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Novo Nordisk: Strict US regulation threatens innovation

Warning from CEO Sorensen comes after Tresiba and Ryzodeg fail to win FDA approval

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