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- PMLiVE

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FDA refuses to back Gilead’s two HIV drugs

Agency questions quality of testing procedures for elvitegravir and cobicistat

- PMLiVE

Lilly expects to submit five drugs for US approval in 2013

Hopes FDA submissions will help offset patent losses for Zyprexa and Cymbalta

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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

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

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

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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

David Novack leaves Novartis for Dynavax

Was global head of technical operations and supply chain for diagnostics at Swiss pharma firm

- PMLiVE

FDA delays GlaxoSmithKline’s pandemic flu vaccine

More time needed due to "administrative" issue

FDA says final mobile app guidance just weeks away

And tells Congress only a fraction of mobile apps will need regulating

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