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News Breaks
February 11, 2013
10:30 EDTSNY, NVOSanofi 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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September 30, 2014
16:39 EDTSNYCMS discloses drug makers' payments to doctors, WSJ says
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10:53 EDTSNYRegeneron dupilumab opportunity improved with new data, says Piper Jaffray
Piper Jaffray said it is increasingly optimistic about dupilumab's broad potential in allergic diseases following the Phase II data on chronic sinusitis with nasal polyps as well as prior data in atopic dermatitis and asthma. The firm views dupilumab as a potential blockbuster and reiterates its Overweight rating and $382 price target on Regeneron (REGN), which announced the data in partnership with Sanofi (SNY).
07:47 EDTNVOJacobs Engineering receives pharmaceuticals pilot plant contract from Novo Nordisk
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07:30 EDTNVO, SNYSachs Associates to hold a conference
14th Annual Biotech in Europe Forum for Global Partnering and Investment to be held in Basel, Switzerland on September 30-October 1.
05:16 EDTSNYRegeneron, Sanofi announce positive Phase 2 top-line dupilumab results
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that a Phase 2a proof-of-concept study of dupilumab, an investigational therapy that blocks IL-4 and IL-13 signaling, met all primary and secondary endpoints in patients with moderate-to-severe chronic sinusitis with nasal polyps, or CSwNP, who did not respond to intranasal corticosteroids. In the study, dupilumab resulted in a statistically-significant improvement in the size of nasal polyps, as measured by endoscopic Nasal Polyp Score, the primary endpoint of the study. Statistically significant improvements in all secondary efficacy endpoints were also observed, including objective measures of sinusitis by CT scan, nasal air flow, and patient-reported symptoms. In a pre-specified exploratory analysis, dupilumab-treated patients who also had asthma demonstrated significant improvements in asthma control. The safety profile was consistent with previous studies. The most common AEs with dupilumab were injection site reactions, nasopharyngitis, oropharyngeal pain, epistaxis, headache and dizziness.
September 24, 2014
17:01 EDTSNYMannKind announces closing of global licensing agreement with Sanofi
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08:10 EDTSNYSanofi unit announces research collaboration
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September 23, 2014
09:00 EDTSNYBofa/Merill special situations team to hold an analyst/industry conference call
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September 22, 2014
07:21 EDTSNYEBD Group to hold a conference
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September 18, 2014
14:20 EDTNVONovo Nordisk announces EC marketing authorisation for Xultophy
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13:13 EDTNVONovo Nordisk Ryzodeg does not meet primary endpoint in phase 3b trial
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