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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).

Regulatory recommendations for biosimilars in the EU Guidelines | Posted 30/07/2010

The regulatory body for approval of medicines in the EU is the EMA. The EU has developed a general legal pathway, and the EMA has developed regulatory guidelines, for the approval of biosimilars (s...

The biosimilars challenge Biosimilars/Research | Posted 30/07/2010

What are the challenges facing biosimilars? This was the question broached in a paper by Professor Håkan Mellstedt of the Department of Oncology, at the Karolinska University Hospital Solna, Stockh...

MSD-Chibret signs generics deal with French manufacturer Reports | Posted 30/07/2010

On 25 June 2010 Merck Sharp & Dohme-Chibret (MSD-Chibret) signed an agreement with subcontractor Fareva under an incentive set up by the strategic council of health industries (Csis) meeting, a...