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EU blocks generics for Third World countries Policies & Legislation | Posted 23/11/2009

Because of their behaviour against alleged patent infringements by Indian pharmaceutical manufacturers, according to the German Financial Times (FTD) the EU gets pressurised.

Biotech drugmakers get 12-year protection in US House health bill Biosimilars/News | Posted 19/11/2009

The US House health reform bill unveiled on 29 October 2009 would grant brand-name biotech-drug manufacturers 12 years of exclusivity before generic versions of their products can rely on their saf...

US FTC ‘hampered’ by Boehringer Ingelheim's delay tactics Policies & Legislation | Posted 19/11/2009

The US Federal Trade Commission (FTC), which is investigating patent settlements between Boehringer Ingelheim and Barr (now part of Teva Pharmaceutical Industries) on Aggrenox (aspirin plus extende...

COSTEFF: Parallel trade, generics, biosimilars and home care can reduce European healthcare costs Policies & Legislation | Posted 17/11/2009

We are all familiar with the pressures piling up on healthcare systems around the world. People are living longer and diseases of ageing, such as dementia, are becoming more prevalent. Some illness...

FDA compared generic and innovator drugs based on 12 years of bioequivalence data Generics/General | Posted 17/11/2009

In the US, manufacturers seeking approval to market a generic drug product must submit data demonstrating that the generic formulation provides the same rate and extent of absorption as (i.e., is b...

Mycenax to start phase III etanercept biosimilar trial Biosimilars/News | Posted 17/11/2009

Protein drug development company Mycenax Biotech of Taiwan announced on 20 October 2009 that its rheumatoid arthritis and psoriasis drug TuNEX, a biosimilar version of etanercept, has successfully...

US Senate panel votes to outlaw ‘pay-for-delay’ deals Policies & Legislation | Posted 16/11/2009

The US Senate Judiciary Committee has voted 12-7 in favour of legislation to outlaw deals agreed between branded drugmakers and generics firms to delay the entry of generic competitors to the market.

Merck & Co uses its traditional strengths in biosimilars race Biosimilars/News | Posted 16/11/2009

With sales growth for biologicals expected to outpace that in the overall pharmaceutical sector over the next few years, it is not surprising that ‘big pharma’ has been beefing up its presence in t...