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As expected, the FDA cleared for marketing Wednesday recombinant human C1 esterase inhibitor Ruconest (conestat alpha) for use in acute attacks of hereditary angioedema (HAE), news that should bring an immediate lift to developer Pharming Group NV.
HONG KONG – China has indicted two investigators linked to the bribery scandal that has rocked Glaxosmithkline plc. The couple – 58-year-old British man Peter William Humphrey and his 61-year-old American Chinese wife Yu Yingzeng – was arrested in Shanghai last August.
Board disagreements have delayed the formal completion of the EMA's new policy on access to clinical trial data. The London-based regulatory agency disclosed late Wednesday that it was unable to agree on final wording for the new policy, which had been due to take effect Oct. 1.
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