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News Breaks
February 10, 2013
18:55 EDTNVO, LLY, SNYNovo Nordisk receives FDA 'Complete Response Letter" for Tresiba and Ryzodeg
Novo Nordisk announced that on 8 February it received a Complete Response Letter from the US Food and Drug Administration, FDA, regarding the New Drug Applications for Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart). A complete Response Letter is issued by the FDA, when the agency determines that an application cannot be approved in its current form. Reference Link
News For NVO;SNY;LLY From The Last 14 Days
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July 24, 2015
14:20 EDTSNYFDA approves Regeneron, Sanofi cholesterol-lowering treatment
The announced the approval of Praluent injection, the first cholesterol-lowering treatment approved in a new class of drugs known as proprotein convertase subtilisin kexin type 9 inhibitors. Praluent is approved for use in addition to diet and maximally tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia or patients with clinical atherosclerotic cardiovascular disease such as heart attacks or strokes, who require additional lowering of LDL cholesterol. Praluent is marketed by Sanofi-Aventis (SNY) and Regeneron (REGN). Shares of Regeneron remain halted.
09:33 EDTLLYEli Lilly weakness creates buying opportunity, says Argus
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07:21 EDTSNYRegeneron, Sanofi say CHMP recommends Euro approval of Praluent treatment
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the European Medicine Agency's Committee for Medicinal Products for Human Use, or CHMP, has adopted a positive opinion for the marketing authorization of Praluent, recommending its approval for use in certain adult patients with hypercholesterolemia. Praluent is an investigational fully human monoclonal antibody targeting PCSK9. The European Commission is expected to make a final decision on the Marketing Authorization Application for Praluent in the European Union in late September. The CHMP opinion was based on the benefit-risk profile of Praluent, following review of efficacy and safety data from more than 5,000 patients across 10 pivotal Phase 3 double-blind trials ranging from six months to two years. Clinical data from the ODYSSEY Phase 3 program show consistent, positive results in reducing LDL-C. The U.S. Food and Drug Administration has set a target action date of July 24 for the Biologics License Application of Praluent. The safety and efficacy of Praluent have not been fully evaluated by any other regulatory authority.
07:18 EDTSNYRegeneron and Sanofi's Praluent recommended for approval in Europe
Regeneron (REGN) and Sanofi (SNY) announced that the European Medicine Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion for the marketing authorization of Praluent, recommending its approval for use in certain adult patients with hypercholesterolemia. Praluent is an investigational fully human monoclonal antibody targeting PCSK9. The European Commission is expected to make a final decision on the Marketing Authorization Application for Praluent in the European Union in late September.
07:16 EDTSNYFDA PDUFA Date for Regeneron and Sanofi BLA for Praluent is July 24, 2015
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July 23, 2015
10:08 EDTLLYOptions with decreasing implied volatility
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08:43 EDTLLYEli Lilly Alzheimer's data positive, says SunTrust
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06:48 EDTLLYEli Lilly up 5.5% after reporting Q2 results, raising FY15 guidance
06:37 EDTLLYEli Lilly expands San Diego biotechnology center
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06:33 EDTLLYEli Lilly raises FY15 EPS view to $3.20-$3.30 from $3.10-$3.20, consensus $3.18
Narrows FY15 revenue guidance to $19.7B-$20B from $19.5B-$20B, consensus $19.8B.
06:30 EDTLLYEli Lilly reports Q2 adjusted EPS 90c, consensus 74c
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July 22, 2015
15:26 EDTLLYNotable companies reporting before tomorrow's open
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10:59 EDTLLYBiogen drops after reporting data on Alzheimer's drug
The shares of Biogen (BIIB) are falling after the company released data on its Alzheimer's treatment candidate, aducanumab. Peer Eli Lilly (LLY) also reported data this morning on its own experimental Alzheimer's drug, solanezumab. BIOGEN: Biogen's data "does not inspire confidence," Piper analyst Joshua Schimmer wrote in a note to investors today. The 6 mg dose of the drug performed similarly to the 1mg dose, and was barely better than the placebo, the analyst stated. The cognitive and functional performance of the patients who took the 6 mg dose did not improve by a statistically significant amount, while the results of patients taking the other doses were "noisy,"Schimmer stated. Additionally, indications of excess fluid in the brain was observed in a significant number of patients, representing an additional problem for the treatment, the analyst believes. The data "is far from inspiring confidence" and makes the outlook for aducanumab "more speculative than ever," Schimmer contended. LILLY: Also this morning, Eli Lilly presented results from a pre-specified secondary analysis of several Phase 3 studies at the Alzheimer's Association International Conference. According to the company, the results suggest the treatment effect of solanezumab was preserved within a pre-specified amount in patients with mild Alzheimer's disease who received solanezumab earlier in the disease compared to patients who began treatment at a later point. Treatment differences in cognition and function between early-start and delayed-start groups at the end of the placebo-controlled period were preserved at the primary time point of 108 weeks within a pre-defined margin. Treatment differences in cognition and function between early-start and delayed-start groups at the end of the placebo-controlled period were also preserved at an additional time point of 132 weeks within a pre-defined margin.The differences at 108 weeks and at at 132 weeks remained statistically significant, the company said. PRICE ACTION: In morning trading, Biogen fell 3% to $397.43 while Eli Lilly shares rose 0.6% to $86.11.
10:05 EDTLLYEli Lilly gaps down, retraces, levels to watch
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08:40 EDTLLYEli Lilly July weekly volatility elevated into Q2 and Alzheimer's drug data
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07:18 EDTLLYEli Lilly drops 3% to $83 after reporting Alzheimer's drug data
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07:06 EDTLLYEli Lilly's solanezumab for Alzheimer's supports 'delayed-start' use
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July 21, 2015
12:47 EDTSNYPiper confident in Regeneron approval by Friday
After Amgen's (AMGN) Repatha received marketing authorization in Europe, making it the first of the anti-PCSK9 antibody to be approved worldwide, Piper Jaffray analyst Edward Tenthoff expressed confidence that Regeneron (REGN) and Sanofi's (SNY) anti-PCSK9 antibody Praluent will be approved by Friday's FDA action date. Tenthoff believes Praluent will eventually be a blockbuster drug, but anticipates the launch to be slow. He keeps a Neutral rating on Regeneron with a $484 price target.
July 20, 2015
07:32 EDTLLYAlzheimer's Association to hold a conference
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July 16, 2015
11:57 EDTNVONovo Nordisk receives FDA approval for FlexPro PenMate
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