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- PMLiVE

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- PMLiVE

Neupogen will be first biologic on FDA biosimilars pathway

US regulator will review Novartis’  version of Amgen's Neupogen (filgrastim) over the coming months

Genentech’s Sunil Agarwal joins rare disease firm

He will serve as chief medical officer at Ultragenyx

- PMLiVE

FDA approves Gilead drug in three blood cancers

Zydelig recommended for use in chronic lymphocytic leukaemia and two forms of lymphoma

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BMJ accuses Boehringer of withholding Pradaxa data

Claims current FDA recommendation for anticoagulant may be flawed

- PMLiVE

FDA approves drug for rare swelling diseases

Salix and Pharming’s Ruconest is made from the milk of genetically-modified rabbits

- PMLiVE

Channel strategy and orphan drugs

A plan for guiding decisions about a product's distribution channel is particularly relevant for orphan drugs, rare diseases or specialty medicines

- PMLiVE

Priority review for Roche’s Avastin in cervical cancer

Will speed up FDA assessment of oncology drug

- PMLiVE

Otsuka and Lundbeck file Abilify follow-up in the US

Brexpiprazole to be reviewed for use in schizophrenia and major depressive disorder

- PMLiVE

Sun Pharma recalls antidepressant in US

Withdraws more than 40,000 bottles of venlafaxine hydrochloride

- PMLiVE

FDA sets out framework for rare childhood diseases

Wants to encourage more trial use of biomarkers and speedier approval timelines

- PMLiVE

FDA to review Sanofi’s Lantus successor

Decision on company’s next generation insulin Toujeo expected early next year

- PMLiVE

The moving parts of orphan drug development

Tackling rare diseases requires high levels of cooperation, regulatory support and a determination to succeed

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