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Avandia's labeling information revised
PHILADELPHIA — GlaxoSmithKline has changed prescribing information on the labeling for one of its Type 2 diabetes drugs to reflect new restrictions on the drug’s use, the drug maker said.
GSK said it revised the labeling for Avandia (rosiglitazone) to take into account the risks of heart attacks and heart failure in patients taking the drug.
The FDA moved to restrict access to Avandia last year and required GSK to create a risk evaluation and mitigation strategy for the drug.
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Elan, Boehringer Ingelheim enter development, manufacturing agreement
DUBLIN — Irish biotech company Elan and German drug maker Boehringer Ingelheim will collaborate to develop and manufacture antibody-based medicines.
The two companies said BI would perform technical development, clinical manufacturing and regulatory filing support, while Elan would lead discovery, preclinical testing, clinical development and commercialization of the drugs. Financial terms of the deal were not disclosed.