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Roche - Basel

Roche’s Herceptin follow-up cleared in US

FDA approval for Kadcyla (formerly T-DM1) in breast cancer

Search appears on FDA’s radar once again

Warning letter to Florida company puts new slant on regulator's digital focus

- PMLiVE

GSK’s COPD drug Anoro under review in US

FDA accepts new drug application for the LAMA/LABA combination

Sanofi reception

FDA to review Sanofi’s lixisenatide for diabetes

Follows drug's European approval under brand name Lyxumia earlier this month

- PMLiVE

Genzyme on track for eliglustat filing in 2013

Says oral Gaucher disease drug as effective as its injectable Cerezyme

- PMLiVE

Global counterfeit drug business driven by crime and corruption

Institute of Medicines says international cooperation needed to tackle falsified medicines

- PMLiVE

Genzyme’s Richard Moscicki joins FDA

Provides regulatory agency with more than 20 years of industry experience

- PMLiVE

FDA fast-tracks Bayer’s prostate cancer radiotherapy

Priority review for radium-223 dichloride, formerly called Alpharadin

- PMLiVE

Bayer submits oral PAH drug riociguat for approval

Set to challenge Actelion and Gilead

- PMLiVE

FDA proffers guidance for new Alzheimer’s drugs

Encourages approach that tackles disease in its early stages

Sanofi’s Steve Oldfield to co-chair UK medicines access group

Takes over from UCB’s Matthew Speers in joint government/industry group

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