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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.
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March 26, 2015
12:50 EDTNVONovo Nordisk to launch Novoeight in U.S. for people with Hemophilia A
Novo Nordisk announced the company will launch Novoeight in the United States for people living with hemophilia A. Novoeight offers purity, reliability, and enhanced portability, with the highest storage temperature for the longest period of time compared with other marketed recombinant Factor VIII products—up to 86 degrees F for 12 months. It can be kept at that temperature for up to 4 hours after reconstitution, giving it the longest postreconstitution storage time. Novoeight offers purity through a 5-step purification process. It was shown to be safe and effective in clinical trials with zero inhibitors confirmed in 213 previously treated patients with hemophilia A. Novo Nordisk plans to make Novoeight available by mid-April.
12:35 EDTNVONovo Nordisk up almost 5%, near highs of session
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12:26 EDTNVONovo Nordisk to resubmit NDAs of Tresiba, Ryzodeg in U.S.
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11:13 EDTNVO, SNYBofA/Merrill European pharma analyst holds an analyst/industry conference call
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05:29 EDTSNYGenzyme reports Cerdelga data shows effectiveness in treating Gaucher disease
Genzyme, a Sanofi company, announced the publication of results from the ENCORE study exploring Cerdelga as a maintenance therapy suitable for adult patients who had reached pre-specific treatment goals on enzyme replacement therapy, or ERT, in the March 26 online issue of The Lancet. ENCORE is a randomized, multinational, Phase 3, open-label, non-inferiority study designed to determine whether patients with Gaucher disease type 1 who had been stabilized after 3 or more years of ERT infusions would remain stable after switching to Cerdelga, a novel, oral, selective inhibitor of glucosylceramide synthase. Eligible patients were randomized 2:1 to receive either oral Cerdelga or ERT with Cerezyme over a period of 12 months. The composite primary efficacy endpoint was the percentage of patients whose hematologic parameters and organ volumes remained stable, using the following stability criteria established for patients with Gaucher disease type 1 on maintenance therapy with Cerezyme: Hemoglobin concentration that did not decrease more than 1.5 g/dL; Platelet count that did not decrease more than 25%; Spleen volume that did not increase more than 25%; Liver volume that did not increase more than 20%. After 12 months, 85% of patients receiving Cerdelga and 94% of patients receiving Cerezyme met the composite endpoint of stability in all four of these measures. The difference between the two treatments was within the pre-specified margins. The principal secondary endpoints were stability with respect to the individual components of the primary endpoint. At least 93% of Cerdelga patients remained stable with respect to hemoglobin concentration, platelet count, spleen volume, and liver volume after 12 months of treatment. Additional endpoints evaluated bone disease, Gaucher disease severity, quality-of-life and Gaucher-disease associated biomarkers.
March 25, 2015
13:22 EDTNVONovo Nordisk says 3a trials achieved primary objectives
Novo Nordisk announced headline results from the final phase 3a trials for faster-acting insulin aspart, onset 1 and onset 2. The trials investigated the efficacy and safety of faster-acting insulin aspart compared with NovoRapid in a basal-bolus regimen in people with type 1 and type 2 diabetes, respectively. Both trials achieved their primary objectives by demonstrating that treatment with faster-acting insulin aspart is non-inferior to NovoRapid with regard to lowering of HbA1c. For people with type 1 diabetes, the HbA1c lowering achieved with faster-acting insulin aspart was statistically significantly larger than that achieved with NovoRapid when the insulins were given at mealtime. In addition, treatment with faster-acting insulin aspart was associated with less increase of postprandial glucose than NovoRapid during meal tests in both trials. In both trials, the previously reported safety and tolerability profiles of faster-acting insulin aspart and NovoRapid were confirmed, and there were no apparent differences between the two treatment groups with respect to adverse events and other safety parameters, Novo said.
12:17 EDTSNYSanofi Pasteur announces FDA approval of Quadracel DTaP-IPV vaccine
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10:03 EDTNVOHigh option volume stocks
High option volume stocks: NVO SXC SONC EXH KRFT WLB ETR LXK APOL EWH
March 24, 2015
10:09 EDTNVOHigh option volume stocks
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08:02 EDTNVOBristol-Myers acquires exclusive license from Novo Nordisk for research program
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March 23, 2015
09:45 EDTNVO, SNYUBS to hold a field trip
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March 22, 2015
12:16 EDTNVONovo Nordisk to hold a conference call
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March 19, 2015
11:07 EDTNVONovo Nordisk management to meet with Jefferies
Meeting to be held in Connecticut on March 24 hosted by Jefferies.
07:09 EDTSNYSanofi reports top-line results for Lyxumia for cardiovascular safety
Sanofi announced top-line results of the Phase IIIb ELIXA cardiovascular outcomes study, which compared lixisenatide to placebo in a high-risk population of adults with type 2 diabetes evaluating cardiovascular safety. The study showed that lixisenatide was non-inferior, although not superior, to placebo for cardiovascular safety. The results will be included in the U.S. New Drug Application of lixisenatide, which is on track to be resubmitted to the FDA in Q3. Lixisenatide is not approved in the U.S.
05:30 EDTSNYSanofi reports lixisenatide was non-inferior, though not superior to placebo
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March 18, 2015
09:32 EDTSNYMannKind faces cash shortfall if $100M debt not settled, TheStreet says
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March 17, 2015
10:00 EDTSNYOn The Fly: Analyst Upgrade Summary
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08:02 EDTSNYSanofi says Shantha will provide up to 37M doses of Shan5
Sanofi Pasteur, the vaccines division of Sanofi, announced that its affiliate Shantha Biotechnics of Hyderabad, India has delivered the first 400,000 doses of its pediatric pentavalent vaccine Shan5 to support the immunization of children in the cities of Gwalior and Jabalpur, both in the state of Madhya Pradesh, India. In December 2014, following a two-year international tender, Shantha was awarded to supply global health organizations with a total of 37M doses of Shan5 in 2015 and 2016, in a ten-dose vial presentation. This tender provides the basis upon which purchase orders will be made for specific vaccine deliveries throughout the period, the company said.
07:43 EDTSNYSanofi upgraded to Outperform on abating concerns at Leerink
Leerink upgraded Sanofi to Outperform from Market Perform saying key concerns around the lack of a CEO, Toujeo positioning and guidance are either resolved or largely factored into expectations. The firm believes the company's currency risk is hedged over time and that its multibillion dollar PCSK9 and dupilumab therapy assumptions have further upside potential. It raised its price target for shares to EUR 106 from EUR 85.
05:40 EDTSNYSanofi upgraded to Outperform from Market Perform at Leerink
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