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Branded generics and generics branding for Merck and sanofi-aventis Generics/News | Posted 06/05/2011

While Merck is getting a firm foothold in emerging markets with a branded generics deal with India-based Sun Pharma, sanofi-aventis has decided to unify its generics business under the brand name Z...

Worldwide biosimilar development Biosimilars/Research | Posted 29/04/2011

The limited access to high-quality biologicals due to the cost of treatment constitutes an unmet medical need in the US and other regions of the world [1].

The EU and rational use of medicines Reports | Posted 29/04/2011

A report produced by the Gesundheit Österreich GmbH / Österreichisches Bundesinstitut für Gesundheitswesen (GÖG/ÖBIG – Austrian Health Institute) surveyed measures for promoting the rational use of...

Change in Canadian exclusivity period may harm generics Policies & Legislation | Posted 29/04/2011

The EU is in negotiations for a comprehensive economic and trade agreement (CETA) with Canada. As part of these negotiations the EU has proposed changes to the length of data exclusivity for origin...

The status of generic substitution in South Africa Generics/Research | Posted 29/04/2011

In South Africa only around 13% of the population live in what we would call ‘first world’ conditions. More than half the population (around 48 million people) live in developing world conditions a...

Generics manufacturers and biosimilars Biosimilars/News | Posted 29/04/2011

According to a report by the Wall Street Journal on 31 January 2011, generic manufacturers are expecting biosimilars to be the next cash cow, with sums in the multibillions of dollars expected to b...

2012’s biggest patent expiries Policies & Legislation | Posted 29/04/2011

Once the patent expiries set for 2011 are gone it is not over for the pharmaceutical industry, as 2012 looks set to be another bumper year for generics, with patents from more of the biggest sellin...

FDA and EMA to join forces on quality Guidelines | Posted 29/04/2011

EMA and FDA have launched on 1 April 2011 a three-year pilot programme to allow parallel evaluation of quality elements, known as Quality by Design (QbD), of selected applications submitted to both...