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May 28, 2014
05:23 EDTLLY, SNYSanofi, Eli Lilly announce licensing agreement for Cialis OTC
Sanofi (SNY) and Eli Lilly (LLY) announced an agreement to pursue regulatory approval of nonprescription Cialis -tadalafil. Cialis is currently available by prescription only worldwide for the treatment of men with erectile dysfunction. Under the terms of the agreement, Sanofi acquires the exclusive rights to apply for approval of Cialis OTC in the United States, Europe, Canada and Australia. Sanofi also holds exclusive rights to market Cialis OTC following Sanofi's receipt of all necessary regulatory approvals. If approved, Sanofi anticipates providing Cialis OTC after expiration of certain patents. Terms of the licensing agreement were not disclosed.
News For SNY;LLY From The Last 14 Days
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January 26, 2015
05:14 EDTSNYRegeneron, Sanofi announce BLA for Praluent accepted for priority review by FDA
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the FDA has accepted for priority review the Biologics License Application, or BLA, for Praluent, alirocumab. Under the Prescription Drug User Fee Act, or PDUFA, the goal for a priority review is six months, for a target action date of July 24. Alirocumab is an investigational monoclonal antibody targeting PCSK9 that is intended for the treatment of patients with hypercholesterolemia. The BLA for Praluent contains data from more than 5,000 patients, including 10 Phase 3 ODYSSEY trials. Together with additional ongoing studies including ODYSSEY OUTCOMES, the ODYSSEY clinical trial program will include more than 23,500 patients at more than 2,000 study centers in double-blind, randomized, placebo-and active-controlled trials ranging from 24 weeks to approximately 5 years. Earlier this month, the companies announced that the European Medicines Agency accepted for review the Marketing Authorization Application for Praluent in the European Union. The EMA and FDA have conditionally accepted Praluent as the trade name for alirocumab. The safety and efficacy of alirocumab have not been fully evaluated by any regulatory authority.
January 22, 2015
05:22 EDTSNYGenzyme Cerdelga granted marketing authorization by EC
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January 21, 2015
10:16 EDTSNY, LLYLeerink biopharma analysts hold an analyst/industry conference call
Analyst Fernandez, along with Dr. Paul Gurbel and Dr. Richard Becker, discuss AstraZeneca's PEGASUS trial and the current use of Brilinta and dual antiplatelet therapy for prevention of CV disease and implications of the recently completed DAPT trial on an Analyst/Industry conference call to be held on January 21 at 1:30 pm.
January 15, 2015
11:20 EDTLLYGoldman cuts J&J to sell citing competitive pressures
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10:00 EDTLLYOn The Fly: Analyst Upgrade Summary
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07:07 EDTLLYEli Lilly upgraded at Goldman
As previously reported, Goldman upgraded Eli Lilly to Neutral from Sell. The firm upgraded shares based on new product launches and pipeline assets, and cost reductions. Price target is $70.
06:44 EDTLLYEli Lilly upgraded to Neutral from Sell at Goldman
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January 13, 2015
12:40 EDTLLYAmgen off highs after Express Scripts CEO talks PCSK9 costs
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08:08 EDTLLYEli Lilly, Merck enter collaborationa greement to evaluate Keytruda, compounds
Merck (MRK) and Eli Lilly and Company (LLY) announced an oncology clinical trial collaboration to evaluate the safety, tolerability and efficacy of KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Lilly compounds in multiple clinical trials: Merck will conduct a Phase 2 study examining the combination of pembrolizumab with pemetrexed in first-line non-squamous, non-small cell lung cancer. This study is currently enrolling. Lilly will conduct a multiple-arm Phase 1/2 study examining the combination of ramucirumab with pembrolizumab in multiple tumors. This study is anticipated to begin in 2015. Lilly will conduct a Phase 1/2 study examining the combination of necitumumab with pembrolizumab in NSCLC. This study is anticipated to begin in 2015. The agreement is between Lilly and Merck, through a subsidiary. Additional details of the collaboration were not disclosed.
08:05 EDTLLYBristol-Myers Eli Lilly enter clinical collaboration pact for Opdivo combo
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January 12, 2015
08:37 EDTSNY, LLYShire deal suggests most biotech companies in play, says JMP Securities
After Shire (SHPG) agreed to buy NPS Pharmaceuticals (NPSP), JMP Securities says the deal indicates that most biotech companies are in play, particularly those with worldwide rights to their products for well-defined patient populations. The firm expects investors to speculate all week about potential new targets in the space. Publicly traded companies in the space include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY).

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