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Landmark EU ruling on supplementary protection certificates Policies & Legislation | Posted 02/12/2011

Pharmaceutical industry groups have broadly welcomed a landmark ruling by the Court of Justice of the European Union (CJEU) clarifying the rules on extended patent protection for multi-disease prod...

US cancer researcher calls for additional biosimilar trials Biosimilars/Research | Posted 02/12/2011

One of the leading cancer researchers in the US has called for biosimilars manufacturers to undertake additional research. In an interview with The ASCO Post, Professor Mark Pegram, MD, Professor o...

Ranbaxy gets FDA approval and launches generic atorvastatin Generics/News | Posted 02/12/2011

After all the speculation India-based Ranbaxy Laboratories (Ranbaxy) has resolved all outstanding issues and finally managed to gain approval from FDA for its generic version of the blockbuster cho...

Twenty per cent of generic drug user fees to come from API manufacturers Policies & Legislation | Posted 02/12/2011

In a presentation by the European Fine Chemicals Group (EFCG) at CPhI Worldwide, Frankfurt, Germany, on 25 October 2011, data was presented showing that generic active pharmaceutical ingredient (AP...

Strides Arcolab gains FDA approval for two cancer generics Generics/News | Posted 02/12/2011

India-based generics manufacturer Strides Arcolab announced on 24 November 2011 that its wholly-owned subsidiary, Onco Therapies, had gained FDA approval for generic versions of cancer treatments c...

Fujifilm and Kyowa Hakko Kirin in biosimilars joint venture Biosimilars/News | Posted 02/12/2011

Japanese Fujifilm Corporation announced on 16 November 2011 that it is once again making an agreement in the biosimilars field, this time with biotech firm Kyowa Hakko Kirin, Tokyo, Japan.

Biosimilars use in Europe Reports | Posted 25/11/2011

A legal framework for approving biosimilars in the EU was established in 2003 and guidelines for an abbreviated registration process were issued in 2006. However, acceptance and use of biosimilars...

Members of parliament to hold inquiry into UK drug shortages Pharma News | Posted 25/11/2011

On 21 November 2011, a group of UK members of parliament (MPs) announced that they will hold a full-scale inquiry into the continuing problem of drug shortages within the National Health Service (N...