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- PMLiVE

Horizon Pharma

- PMLiVE

Smaller companies driving innovation in pharma

IMS Health says specialty medicines are creating a level playing field

Novartis building

FDA rejects Novartis’ breakthrough heart failure drug

Regulator wants more data on serelaxin

- PMLiVE

FDA unveils new biosimilars guidance

Will clarify route to market for copies of biological drugs

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Amgen appoints ex US surgeon general

Steven Galson is also a former director of the FDA’s Center for Drug Evaluation and Research

- PMLiVE

Xtandi on course for pre-chemo use in prostate cancer

US FDA grants priority review to Medivation and Astellas drug

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FDA grants priority review to Merck’s cancer antibody

Will speed up assessment of MK-3475 in skin cancer melanoma

- PMLiVE

FDA approves AZ’s fish oil drug

Epanova gets green light to reduce high levels of fat in the blood

- PMLiVE

FDA approval for Nova’s leukaemia drug

Purixan expected to provide more accurate dosing for children

Novartis building

Novartis gets US nod for lung cancer relapse therapy Zykadia

Second ALK inhibitor to be approved after Pfizer’s Xalkori

- PMLiVE

Following the biologic path

Biosimilar regulations in Canada, the US and Europe all have a degree of uncertainty

- PMLiVE

FDA approves Janssen drug for rare Castleman’s disease

Sylvant approved to treat lymphoma-like condition

- PMLiVE

Lilly’s stomach cancer drug cleared by FDA

Cyramza is tipped to reach blockbuster status depending on approvals

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