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Hospital-owned generics initiative unlikely to benefit the CMO industry

A recently-announced plan to establish a not-for-profit generic pharmaceutical company is unlikely to be a boon to the ...

Uhlmann helps enhance packaging capacity of CMO Surepharm Services

British pharmaceuticals CMO Surepharm Services has experienced streamlined productivity following its installation of ...

Sartorius Stedim Biotech launches chemistry testing services

Allows structural and functional analyses to be conducted in parallel to deliver a comprehensive data package for ...

Labelling and generics: who is accountable?

Bindu Narang, Director of Regulatory Affairs and Scientific Writing, Sciformix Corporation, considers the impact of ...

Global generics market to experience double-digit growth through to 2021

America remains good for growth, whereas Europe lags behind even the UK, with its large generics market

Patent battle for Aloxi in the US

Helsinn Healthcare and Eisai fall foul of reversed court decision regarding Teva Pharmaceuticals and Aloxi patent for ...

The race to be first: drug delivery systems for biosimilars

For biosimilar manufacturers, the market potential is significant, especially for those that are first to market

FDA guidance gives IV approach biowaiver status

Using in vitro release rate and skin permeation testing, sponsors can implement a straightforward, compliant biowaiver ...

CPhI Japan to explore changes in generics and OTC

Growing market for generics and liberalisation of OTC medicines driving demand at CPhI Japan

Time to address price hikes in US generic drugs

Generic drugs costs have climbed dramatically in recent years, hitting US patients and producers. Edward S. Price, PCI ...

GDUFA the promise and the reality

The introduction of GDUFA was meant to reduce a regulatory backlog and improve patient safety. Edward Price, President, ...

Key biologics patents expiring in 2020

$100bn of revenues will become available to drug manufacturers by 2020, as patents for key biologics expire

Groundbreaking declaratory relief clears the route to market for Humira biosimilars

Fujifulm Kyowa Kirin Biologics (FKB), a biosimilar pharmaceutical company from Japan, has been granted the first ever ...