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Biogen Idec’s controversial multiple sclerosis (MS) drug Tysabri will now be available in Europe for serious cases of the disease, the company announced.
The European Commission (EC) has granted marketing authorization for sanofi-aventis’ Acomplia in all 25 European member states, making it the first of a new type of drugs to be approved to treat obesity, the company said June 21.
Fighting a controversial European Union (EU) plan that increases the penalties companies could face for failure to comply with safety requirements will be an uphill climb for the drug industry, a legal expert says.
The European Union recently implemented the EU Clinical Trials Directive (CTD) to better protect clinical trial participants while streamlining the bureaucracy to make the EU more attractive for clinical research (CTA, Nov. 17, 2005, Page 1) (http://www.fdanews.com/cta/10_22/ctrial/48541-1.html).
The drug industry faces a daunting obstacle in fighting a controversial E.U. policy that ramps up the penalties companies could face for failure to comply with safety requirements, a legal
expert says
The drug industry faces a daunting obstacle in fighting a controversial E.U. policy that ramps up the penalties companies could face for failure to comply with safety requirements, a legal expert says.
The European Union recently implemented the EU Clinical Trials Directive (CTD) to better protect clinical trial participants while streamlining the bureaucracy to make the EU more attractive for clinical research (CTA, Nov. 17, Page 1).
The European Union (EU) will soon face an increase in parallel trade, the practice of capitalizing on different drug prices in different markets, as new member nations begin to engage in such activity, according to a report released April 25 by market research firm Datamonitor.
DOR BioPharma today announced the European Union's European Agency for the Evaluation of Medicinal Products (EMEA) has granted the company Small and Medium Sized Enterprises (SME) incentives.