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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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May 21, 2015
14:48 EDTSNYRegeneron primary driver remains Praluent, says Piper Jaffray
Piper Jaffray noted that Regeneron (REGN) shares are at all-time highs after the company and partner Sanofi reported Phase IIb data on Dupilumab and Phase III data on Sarilumab. However, the firm believes the primary driver for Regeneron remains Praluent and firm expects launch costs to outstrip sales growth. Piper acknowledges Regeneron has "one of the richest pipelines in all of biotech," but it sees risk around Amgen's (AMGN) patent suit and keeps its Neutral rating and $484 price target on the stock.
06:38 EDTNVONovo Nordisk rejects claims made by Baxter, Reuters says
Novo Nordisk (NVO) rejects claims made by Baxter (BAX) that the company used substances made by Baxter in its Novoeight haemophilia treatment, following Monday's ITC investigation announcement, reports Reuters, citing an email from Novo Nordisk. Reference Link
05:15 EDTSNYRegeneron, Sanofi announce positive topline results from sarilumab Phase 3 study
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May 20, 2015
10:26 EDTNVOJanssen acquires licence from Novo Nordisk for autoimmune disease development
Novo Nordisk (NVO) announced it has signed an agreement with Janssen Biotech (JNJ) under which Janssen will acquire an exclusive global license to further develop and commercialize a clinical program focused on therapy within autoimmune diseases. The program targets modulation of certain immune cells via a cell surface receptor, specifically the NKG2D receptor. Terms of the agreement have not been disclosed.
May 19, 2015
06:55 EDTSNYGenocea could be takeover target after data, says Piper Jaffray
Piper Jaffray analyst Edward Tenthoff expects Genocea Biosciences (GNCA) will report positive Phase II GEN-003 post-immunization results late in Q2. GEN-003 is a therapeutic vaccine for genital herpes targeting Herpes Simplex Virus Type 2. Positive GEN-003 data could position Genocea as a potential acquisition target by a larger vaccine player, Tenthoff tells investors today in a research note. Large vaccine makers include Sanofi (SNY), Merck (MRK), GlaxoSmithKline (GSK), Pfizer (PFE) and Novartis (NVS). The analyst reiterates an Overweight rating on Genocea with a $14 price target. Shares of the clinical-stage vaccine developer with a $227M market capitalization closed yesterday up 83c to $10.22.
May 18, 2015
12:34 EDTSNYRegeneron, Sanofi announce positive pivotal Phase 2b dupilumab data in asthma
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May 17, 2015
14:59 EDTSNYL'Oreal CEO 'ready' to sell Sanofi stake if needed, Barron's says
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May 15, 2015
10:29 EDTSNYAmerican Urological Association to hold an annual meeting
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May 13, 2015
07:31 EDTSNYHeart Rhythm Society to hold a conference
Heart Rhythm 2015 is being held in Boston on May 13-16.
07:05 EDTSNYSanofi exercises option on therapeutic program with Selecta Biosciences
Selecta Biosciences., a clinical stage biotechnology company developing a novel class of targeted antigen-specific immune therapies, today announced that, under the terms of an existing strategic global collaboration, Sanofi has exercised its option to an exclusive license to develop an immunotherapy for the treatment of celiac disease. Under the terms of the collaboration, Selecta is eligible to receive research support and several pre-clinical, clinical, regulatory and sales milestones totaling up to $300 million for this new program in celiac disease. Additionally, Selecta is also entitled to up to double digit tiered royalties as percentage of product net sales for any commercialized immunotherapy resulting from these efforts with Sanofi. November 2012, Selecta announced that they had formed a strategic global collaboration to discover highly targeted, antigen-specific immunotherapies for life threatening allergies. Under the agreement, Sanofi obtained a first exclusive license to develop an immunotherapy designed to abate acute immune responses against a life threatening food allergen and an option to develop two additional candidate immunotherapies for allergies and celiac disease. With the exercise of this option by Sanofi, Selecta and Sanofi now have two initiatives actively advancing immune tolerance treatments under the terms of the 2012 agreement. In October 2014, Selecta and JDRF announced another collaboration with Sanofi to research novel antigen-specific immune therapies for Type 1 Diabetes.

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