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eosinophilic

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EMA publishes marketing application guidance for pharma

Aims to clarify what to include in summaries of product characteristics

- PMLiVE

Pfizer gets CHMP backing for leukaemia drug bosutinib

Provides option for patients resistant to tyrosine kinase inhibitors

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Allergan gets US approval for Botox in overactive bladder

Could add $200m to annual sales

- PMLiVE

Santhera’s Raxone turned down for rare eye condition

EMA concerned about drug's ability to improve eyesight

- PMLiVE

EMA recommends suspension of Merck’s Tredaptive

Pharma company had already anticipated decision by withdrawing product worldwide

- PMLiVE

FDA approves first egg-free flu vaccine Flublok

Insect virus production method means more vaccine can be produced at a faster rate

- PMLiVE

FDA fast tracks two new lung cancer drugs

Boehringer’s afatinib and Roche/Astellas’ Tarveca receive accelerated review process

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J&J gets FDA panel backing for canagliflozin

Moves ahead of BMS/AZ’s Forxiga in race for US approval as first in new class of diabetes drug

- PMLiVE

FDA lowers recommended dose for sleeping pills

Says insomnia drugs like Ambien could impair ability to drive in morning

- PMLiVE

Olympic gold medalist becomes face of Asthma UK

Cyclist Laura Trott is supporting the charity’s Facebook page

- PMLiVE

FDA releases guidance on how to prevent abuse of opioid painkillers

Explains to companies best ways to make tamper-resistant drugs

EMA launches eSubmission web tool

Will accept eCTD applications from January 15

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