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Pharma news in brief

Our weekly round-up of news affecting the industry

Patient groups not disclosing levels of pharma sponsorship, says study
Only 11 per cent of the UK's 530 largest patients' groups state publicly that they receive support from the pharmaceutical industry, according to a study by market research and publishing house, Patient View. Based on declarations on websites and in annual reports, the study found that just 10 groups stated the percentage of income they received from pharma firms, with only 58 acknowledging some level of corporate support. Alexandra Wyke, head of Patient View, said: ìThis data shows [patient groups] have a long way to go.î

Ketek approval questioned
US lawmakers have questioned the Food and Drug Administration's (FDA) 2004 approval of sanofi-aventis' antibiotic Ketek, concerned that the regulator dismissed problems with a major trial after several doctors were cited by agency investigators for falsifying data or improper record-keeping. In an April 27 letter to the FDA, Senate Finance Committee chairman, Charles Grassley, said some information supporting Ketek's approval was ìbeset by systemic data integrity problemsî. The FDA had rejected the drug in 2001 and 2003, asking for more safety information.

Nexium gets FDA nod for use in children
The US Food and Drug Administration (FDA) has given clearance to AstraZeneca to market its heartburn blockbuster, Nexium, for use in children aged 12 to 17. AZ said it would begin marketing the drug for short-term treatment of gastroesophageal reflux disease in children. Nexium had sales of $4.6bn in 2005, making it the fifth best-selling drug in the world. In a company study, the drug showed no safety risk when given for eight weeks to 149 children, the Anglo-Swedish firm said.

30th September 2008

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