AbbVie sues EMA over release of patient data
AbbVie has filed a request for an injunction, according to the Financial Times, to prevent the EMA from releasing data regarding the company’s rheumatoid arthritis treatment, Humira.
AbbVie is seeking to prevent the release of patient-level data from clinical trials for Humira. This is, according to a report, “to protect AbbVie’s confidential and commercially-sensitive information.” According to the report, AbbVie is in support of “transparency of clinical research and safety information for the benefit of patients and healthcare professionals, (but not) the disclosure of commercially confidential information that does not meaningfully contribute to the scientific review or evaluation of our products.”
The filing follows two Freedom of Information requests to the EMA in 2012 to release “raw data” on the medication’s safety and efficacy, one of which was made by a pharmaceutical company that sells a rival product.
Transparency? AbbVie Sues EMA Over Trial Data (Pharmalot)
AbbVie Seeks to Block Release of Clinical Trial Data –Report (Fox business)
Pharma group sues European regulator over data (Financial Times)
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