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European Commission welcomes reduction in ‘potentially problematic’ patent settlements Policies & Legislation | Posted 13/08/2010

A European Commission (EC) report on the monitoring of patent settlements has found that the number of patent settlements in the pharmaceutical sector that are ‘potentially problematic’ under the E...

Ranbaxy to transfer R & D and focus on generics Pharma News | Posted 13/08/2010

On 2 July 2010, the Japanese Daiichi Sankyo Group and Indian-based Ranbaxy Laboratories announced that Ranbaxy’s New Drug Discovery Research (NDDR) has been transferred to Daiichi Sankyo India Phar...

Rights to Allegra acquired by generics’ manufacturer Perrigo Pharma News | Posted 10/08/2010

On 29 June 2010, Perrigo announced that it had acquired the exclusive US rights to sell and distribute OTC versions of Fexofenadine HCl 180 mg and 60 mg tablets, plus Fexofenadine HCl 60 mg and Pse...

Generics’ manufacturer Hospira merges with Javelin Pharma News | Posted 10/08/2010

On 22 June 2010, Hospira announced that it had successfully acquired 79% of the stock in Javelin Pharmaceutical’s. The merger agreement also allows for Hospira to exercise a ‘top-up’ option to incr...

FDA Form 483 – punishment or learning opportunity? Guidelines | Posted 10/08/2010

The US FDA is authorised to perform inspections under the Federal Food, Drug, and Cosmetic Act. The FDA Form 483 is a form used by the FDA to document and communicate concerns discovered during the...

Court upholds decision against AstraZeneca’s omeprazole Generics/News | Posted 10/08/2010

On 1 July 2010, the General Court of the European Union (GCEU) upheld the decision of the European Commission (EC), which found that AstraZeneca had abused its dominant position by preventing the m...

US bill to curb generic ‘pay-for-delay’ deals Policies & Legislation | Posted 10/08/2010

US drugmakers reacted with anger on 2 July 2010, as the House of Representatives voted in favour of measures to severely curb ‘pay-for-delay’ deals between brand name and generic firms, which have...

Generics lose battle against AstraZeneca’s Crestor (rosuvastatin) Generics/News | Posted 30/07/2010

On 30 June 2010, AstraZeneca announced that a court in the US had overruled challenges, from a number of generic producers, to the patent on its blockbuster cholesterol drug, Crestor (rosuvastatin).