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- PMLiVE

tolvaptan

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Otsuka launches European ADPKD forum

Aims to lead awareness raising plans for rare genetic condition

- PMLiVE

FDA begins data initiative with millions of adverse event reports

Will provide web developers and others with access to large public health datasets

- PMLiVE

FDA fast-tracks new AstraZeneca antibiotic

Speeds up review period for AZD0914 in gonorrhoea

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Smaller companies driving innovation in pharma

IMS Health says specialty medicines are creating a level playing field

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Japanese product news in brief

Home launch for Astellas' Xtandi, GSK files COPD drug for approval and more

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

- PMLiVE

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

- PMLiVE

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

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