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Latest From Immunex Corp.

Emflaza's 505(b)(2) Pathway Review: Rare, But With Precedent

US FDA has relied on 505(b)(2) pathway to approve a small group of 'orphaned orphan' drugs – products without patent protection being used on an informal 'gray market' of personal importation and compassionate use protocols.

Drug Review Profile Drug Approval Standards

Novartis/Sandoz Biosimilar Erelzi OK'd; Covets Enbrel's US Sales

Novartis AG unit Sandoz Inc. won US approval of its biosimilar Erelzi, which is referenced on Amgen's tumor necrosis factor blocker Enbrel (etanercept). The product, however, currently is caught in a patent dispute, although a recent stipulation has provided some hope for a smoother path through the legal jungle than other biosimilars may face.

Approvals Biosimilars

APPOINTMENTS: Valeant, Gilead, Editas, Daiichi, Scancell, PhaseRx, Clintec, Acadia

This week’s announcements include Valeant’s appointment of an executive vice president finance, Editas Medicine’s appointment of a chief scientific officer, Clintec’s appointment of AstraZeneca’s former global research director and various board appointments by Acadia, Scancell, PhaseRx and Gilead.

Appointments BioPharmaceutical

Sandoz Skips Enbrel Biosimilar Patent Dance, Spurs Infringement Suit

For second time Sandoz faces claims it is trying to reap benefits of biosimilars law without meeting its obligations.

BioPharmaceutical United States
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