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Roche - Basel

EMA launches probe into Roche’s adverse event reporting

Pharma company allegedly failed to follow pharmacovigilance procedures

Eisai’s epilepsy drug Fycompa gets green light in US

Japanese firm predicts global sales of more than $1bn at peak

- PMLiVE

Vivus fails to get European backing for obesity treatment Qsiva

EMA raises concerns about drug’s cardiovascular safety

Europe set to approve first Glivec generic

CHMP backs Teva version of Novartis' blockbuster cancer drug

- PMLiVE

FDA panel backs Sanofi’s Kynamro for high cholesterol

Recommendation comes despite safety concerns

Dr Ian Hudson elected vice chair of CHMP

Will serve a three-year term on EMA's scientific advisory committee

- PMLiVE

Death toll reaches 19 in US meningitis outbreak

Victims exposed to contaminated drugs

- PMLiVE

Novo Nordisk files new haemophilia drug in EU, US

Seeks approval for turoctocog alfa shortly after vatreptacog alfa pulled

Celgene’s Abraxane receives FDA approval in lung cancer

Adds to current breast cancer indication

European orphan drug applications up 30 per cent

But lower than expected generics applications see EMA reduce new marketing authorisation forecast

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European pharmacovigilance changes approved

European Council formally approves new drug safety legislation

- PMLiVE

Massive crackdown on online pharmacies nets fake drugs

Global agencies shut down 18,000 websites and seize medicines worth $10.5m

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