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News Breaks
February 11, 2013
10:30 EDTNVO, SNYSanofi advances after FDA delays rival insulin product
Sanofi (SNY) is climbing after the FDA decided that rival Novo Nordisk (NVO) would have to carry out a new study on its insulin product, Tresiba, before the product could be approved in the U.S. Sanofi's Lantus insulin competes with Tresiba, which has already been approved in Europe and Japan. Both Lantus and Tresiba are long acting insulin products, but Tresiba is effective for a longer time period and can be dosed more effectively, Novo has stated. The FDA required a new study to assess the effects of Tresiba on the heart before the product could be approved in the U.S. The study results probably won’t be reported before 2015, Novo said. In mid-morning trading, Sanofi advanced 90c, or 2%, to $47.40, while Novo Nordisk tumbled $26, or 13.50%, to $166.50.
News For SNY;NVO From The Last 14 Days
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April 20, 2015
09:20 EDTSNYLeerink biotech analyst holds an analyst/industry conference call
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April 15, 2015
11:56 EDTSNYSanofi initiated with a Buy at Societe Generale
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11:55 EDTNVONovo Nordisk initiated with a Sell at Societe Generale
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07:41 EDTNVO, SNYEBD Group to hold a forum
ChinaBio Partnering Forum 2015 is being held in Shanghai, China on April 15-16.
April 7, 2015
15:44 EDTNVONovo Nordisk announces FDA accepts Tresiba, Ryzodeg resubmissions for review
Novo Nordisk announced that the U.S. FDA has accepted for review the Class II Resubmissions for Tresiba and Ryzodeg. To preserve the integrity of the ongoing DEVOTE trial, only a small team within Novo Nordisk has access to the data. This team has prepared the interim analysis for the Class II resubmission and will interact with the FDA during the review, on matters related to the interim analysis. As previously communicated, the result of an interim analysis carries a higher level of uncertainty than the final study results as this preliminary estimate is built on a substantially lower number of observations. Accordingly, the relative risk estimate derived from the interim analysis is thus only an indication of the final trial results. Novo Nordisk management does not have access to the results of the interim analysis. The trial is expected to be completed in the second half of 2016.
07:14 EDTSNYEyeforpharma to hold a summit
Philadelphia 2015 Commercial Pharma Summit is being held in Philadelphia on April 7-8.

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