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Nigeria needs to combat fake drugs and ageing facilities Pharma News | Posted 14/06/2013

Nigeria has ageing drug-manufacturing facilities and a problem with imports of fake drugs, according to Mr Olakunle Ekundayo, Group Managing Director, Drugfield Pharmaceuticals.

Indian Government moves closer to complying with EU API rules Policies & Legislation | Posted 14/06/2013

On 23 May 2013, the Indian Government announced that it had issued finalized guidelines for drugmakers to comply with a European Union (EU) directive on standards for import of active pharmaceutica...

EMA’s Richardson talks about biosimilars in Europe Reports | Posted 07/06/2013

Biosimilars have been available in Europe for more than seven years. In the US, however, despite legislation being passed in 2010 to allow for a biosimilars pathway, a biosimilar has yet to be appr...

Positive post-marketing data for biosimilar epoetin Biosimilars/Research | Posted 07/06/2013

Injectable generics specialist, Hospira, presented results from a post-marketing study of the company’s European biosimilar epoetin (Retacrit) on 3 June 2013 at the 48th Annual Meeting of the Ameri...

EU to fine 9 drugmakers over pay-for-delay deals Policies & Legislation | Posted 07/06/2013

The European Commission (EC) is reportedly ready to fine Danish pharmaceutical company Lundbeck and eight generics makers over alleged pay-for-delay deals in Europe.

Celltrion applies for Korean approval of biosimilar trastuzumab Biosimilars/News | Posted 07/06/2013

On 4 June 2013, South Korean biotechnology company Celltrion announced that it had filed for approval of its biosimilar candidate CT-P6 with the Korean Ministry of Food and Drug Safety (MFDS, forme...

Use of G-CSF biosimilars for stem cell mobilization in autologous transplantation Biosimilars/Research | Posted 07/06/2013

The first biosimilar granulocyte colony-stimulating factor (G-CSF) was licensed by EMA in 2008, and there are currently six biosimilar G-CSF products licensed for use in the EU [1]. All of these bi...

Sun Pharma looking to buy Sweden’s Meda Pharma News | Posted 07/06/2013

India-based Sun Pharmaceutical Industries (Sun Pharma) is reportedly in talks to acquire Swedish drugmaker Meda for US$5–6 billion.