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April 18, 2014
13:32 EDTCBSTCubist announces voluntarily recalling one Cubicin lot
Cubist Pharmaceuticals announced it is voluntarily recalling one lot of Cubicin to the user level due to the presence of particulate matter, reported via customer complaint and identified as glass particles, found in a single vial from this lot, produced by a contract manufacturer. The administration of glass particulate, if present in an intravenous drug, poses a potential safety risk to patients. Case reports suggest that sequelae of thromboembolism, some life-threatening, may occur, the company said. There have also been reports in the literature of particulate possibly causing phlebitis, mechanical block of the capillaries or arterioles, activation of platelets, subsequent generation of microthrombi, and emboli. No adverse events have been reported to date in association with a product complaint of vials containing glass particulate.
News For CBST From The Last 14 Days
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September 1, 2014
11:26 EDTCBSTAmerican Society for Microbiology to hold a conference
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August 31, 2014
14:04 EDTCBSTWorldwide Business Research to hold a conference
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August 22, 2014
07:31 EDTCBSTCubist annouces EMA acceptance of ceftolozane, tazobactam MAA
Cubist announced that the European Medicines Agency has accepted for review the company’s Marketing Authorization Application for its investigational antibiotic ceftolozane, tazobactam. Cubist is seeking approval of ceftolozane/tazobactam for the treatment of complicated urinary tract Infections and complicated intra-abdominal infections, with a decision from the European Commission expected during 1H15. The MAA submission is based on positive data from two pivotal Phase 3 clinical trials of ceftolozane, tazobactam in complicated urinary tract infections and complicated intra-abdominal infections. These studies met both the EMA and U.S. Food and Drug Administration specified primary endpoints. Results of the secondary analyses were consistent with and supportive of the primary outcomes.

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