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ICMRA

- PMLiVE

Two new cancer drugs recommended in Europe

CHMP backing for Roche's Erivedge and Astellas' Xtandi

- PMLiVE

EMA refuses to back Pfizer’s Xeljanz in rheumatoid arthritis

Surprise after approvals in US and Japan

- PMLiVE

EC gives green light to new 6-in-1 childhood vaccine from Sanofi, MSD

Hexyon/Hexacima protects against diphtheria, DTP, hepatitis B, polio, meningitis and Haemophilus influenzae type B

- PMLiVE

European drug applications ‘stable but more complex in 2012’

Despite austerity measures, EMA's annual report shows signs of biopharma resilience

- PMLiVE

FDA stung by damning fraudulent research report

Agency accused of leaving untested drugs on the market

- PMLiVE

FDA bars generic version of Purdue’s painkiller OxyContin

New abuse-deterrent formulation means original version no longer has positive benefit-to-risk profile

- PMLiVE

EMA recommends heart risk restriction for Servier’s Protelos

Use of osteoporosis drug likely to be further tightened up

- PMLiVE

Sanofi’s four-strain flu vaccine Vaxigrip under review in EU

Pharma company also launches production of ingredient for malaria drug

- PMLiVE

FDA approves return of morning sickness drug for pregnant women

Regulator confirms safety of Diclegis – formerly known as Bendectin

- PMLiVE

Clinical trials for EMA-submitted medicines move away from US and Europe

Most trial patients for drug marketing applications to EMA now come from rest of the world

Bayer symbol

Bayer’s riociguat fast-tracked by FDA

Could provide oral option in pulmonary arterial hypertension market

- PMLiVE

GSK’s four-strain flu vaccine approved in Germany and UK

Will be sold as Influsplit Tetra in Germany and Fluarix Tetra in the UK

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