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- PMLiVE

safinamide

European orphan drug applications up 30 per cent

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

EU flag

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

Teva pulls generic version of antidepressant Wellbutrin XL in US

FDA says copy is not equivalent to branded drug

- PMLiVE

Bayer gets US green light for colorectal cancer drug Stivarga

Follows FDA approval for Sanofi and Regeneron's Zaltrap in same indication

- PMLiVE

FDA launches campaign warning public of dangers of online pharmacies

BeSafeRx advises US citizens on how to make safe drug purchases using internet

FDA sets new date for Eliquis review in atrial fibrillation

US regulator had asked for more data from Pfizer and BMS

EMA recommends Lilly’s erectile dysfunction drug for enlarged prostate

Cialis would be first drug available in Europe for both ED and BPH

Almirall’s IBS drug Constella backed by CHMP

On track to become the first drug specifically approved for the condition

- PMLiVE

Vivus expects knockback from EMA for obesity drug

Setback comes despite US approval for Qsiva/Qsymia

Novartis building

CHMP backs trio of Novartis products

Including two diabetes drugs and one for non-cancerous kidney tumours

Bayer files low dose contraceptive patch for EU approval

Will offer alternative to J&J’s Evra

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