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EMA definitions of generics and biosimilars
2012-01-16 Confusion surrounding terms used in the global field of generics and biosimilars is a recognised problem. The members of the Biosimilar Medicinal Products Working Pa...
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Indian Transgene sells biosimilar to German TSS Export
2012-01-13 India-based biotech company Transgene Biotek Limited (Transgene) announced on 24 November 2011 the sale of technology for biosimilar recombinant human erythropoietin...
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Translational research to uncover new uses for generics
2012-01-12 On the surface, generic compounds and translational medicines could not appear more different. However, in April 2011, the US National Institutes of Health (NIH) met...
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Integrated prescriber dispensing can slow generic growth
2012-01-11 Countries such as China, Japan and Taiwan which have public health insurance systems, and which allow physicians to both prescribe and dispense drugs themselves, are...
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Perception of generic drugs as fake among Pakistani immigrants
2012-01-10 Pakistani immigrants in Norway may confuse generic drugs with counterfeit drugs, according to research carried out by Norwegian researchers.Patients using antihypert...
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Italy and Spain threaten legal action over EU patent
2011-12-20 EU ministers have adopted a general approach to the two Commission proposals that provide for a European patent to protect inventions in the same way in all particip...
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Can biosimilar manufacturers learn from generic substitution issues
2011-12-19 The substitution of generic prescription medicines for branded medicines is practiced in most Westernised countries, mainly because of its clear economic benefits. P...
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European Commission investigates Johnson & Johnson and Novartis over delaying generics
2011-12-16 As part of its ongoing antitrust investigations, the European Commission (EC) announced on 21 October 2011 that it is looking into agreements between Johnson & J...
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Pakistani immigrants may confuse generics with counterfeit drugs
2011-12-15 A study by Norwegian researchers showed that generics substitution may lead to lack of compliance in Pakistani immigrants in Norway, due to misconceptions and confus...
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European Council gives go-ahead for EU patent – but is it legal
2011-12-14 The European Council announced that it had given the go-ahead on 10 March 2011 for use of a rarely used provision of the Lisbon Treaty known as ‘enhanced cooperation...
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Biosimilars: barriers to entry and profitability in the EU and US
2011-12-13 The implications of the US biosimilars law and the pending patent expiries of the 12 major biological products in the EU and the US will have an impact on the profit...
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Pilot programmes between EMA, FDA and TGA a success
2011-12-12 Two pilot programmes of collaboration on inspections between EMA, FDA and the Australian Therapeutic Goods Administration (TGA) have concluded successfully, accordin...
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