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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Ionis Pharmaceuticals Inc | NASDAQ:IONS | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-0.01 | -0.02% | 41.25 | 41.25 | 50.00 | 1,669 | 12:20:36 |
U.S. pharmaceutical company Genzyme, a unit of French group Sanofi SA (SAN.FR), and Isis Pharmaceuticals Inc. (ISIS) Friday said the Committee for Medicinal Products for Human Use of the European Medicines Agency, the body that authorizes drugs in the European Union, issued a negative opinion for Kynamro, a drug treating homzygous familial hypercholesterolaemia.
MAIN FACTS:
- Genzyme plans to request a re-examination of the negative opinion.
- Genzyme and Isis said an application of Kynamro is currently under review by the U.S. Food and Drug Administration.
- The companies said Kynamro received in October 2012 a positive vote by the FDA advisory panel, which had said the company had provided sufficient efficacy and safety data to support the marketing of the drug for the treatment of patients with homozygous familial hypercholesterolemia
-Write to Inti Landauro at inti.landauro@dowjones.com
Subscribe to WSJ: http://online.wsj.com?mod=djnwires
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