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Novartis orphan drug wins ‘breakthrough’ status from FDA

Bimagrumab could be first treatment for rare life-threatening muscle-wasting condition

- PMLiVE

Pfizer faces NICE rejection for lung cancer drug

Xalkori not cost-effective use of NHS resources in England and Wales

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Amgen buys US rights to Servier’s Procoralan

Also obtains option to develop S38844 while Servier has option to commercialise omecamtiv mecarbil in Europe

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ViiV gets US nod for HIV drug dolutegravir

GSK and Pfizer joint venture on course for first drug launch

Bayer symbol

Bayer moves closer to US approval of PAH drug riociguat

FDA panel votes unanimously in favour of hypertension treatment

- PMLiVE

FDA panel turns down Otsuka’s drug for rare kidney disease

Unable to recommend expanded use of tolvaptan

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GSK’s diabetes hope albiglutide delayed in US

FDA extends deadline to April 2014

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Lilly to support training of scientists from ethnic minorities

Pharma company will work with Roswell Park Cancer Institute

Sanofi reception

FDA panel backs OTC use of Sanofi’s allergy drug

Says Nasacort AQ can be sold without prescription

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Boehringer: clinical trial set-up poses challenge in rare diseases

Says more support needed in regulatory process for orphan drugs

Actelion HQ Switzerland

Actelion to buy Ceptaris – if FDA backs its cancer treatment

Acquisition contingent on Valchlor approval in rare lymphoma

- PMLiVE

Pfizer sales dip as net income surges in Q2

Lipitor performance weighs heavy on the figures

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