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Stock Market & Financial Investment News

News Breaks
January 29, 2013
18:33 EDTSNY, ISISSanofi, Isis announced FDA approval of Kynamro injection
Genzyme, a Sanofi (SNY) company, and Isis Pharmaceuticals (ISIS) announced that the U.S. Food and Drug Administration has approved its New Drug Application for Kynamrotm injection. Kynamro, given as a 200 mg weekly subcutaneous injection, has been approved as an adjunct to lipid-lowering medications and diet to reduce low density lipoprotein-cholesterol, apolipoprotein B, total cholesterol, and non-high density lipoprotein-cholesterol in patients with homozygous familial hypercholesterolemia. Kynamro contains a Boxed Warning citing the risk of hepatic toxicity. Patients taking Kynamro should have liver enzyme testing before starting the drug and periodically thereafter. The safety and effectiveness of Kynamro have not been established in patients with hypercholesterolemia who do not have HoFH. The effect of Kynamro on cardiovascular morbidity and mortality has not been determined.
News For SNY;ISIS From The Last 14 Days
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July 21, 2014
07:11 EDTSNYInternational Society of DNA Vaccines to hold a conference
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July 17, 2014
07:10 EDTISISIsis Pharmaceuticals begins Phase 2 study of candidate for high lipoprotein(a)
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July 16, 2014
09:03 EDTSNYSanofi held talks on mature drugs with Abbott, Mylan, PE firms, Reuters says
Sanofi (SNY) has shopped an $8.5B portfolio of mature drugs to Abbott (ABT), Mylan (MYL) and private equity firms, according to Reuters, citing an internal company document circulated by the CGT union. Sanofi is considering whether to sell, carve out or create a joint venture for the portfolio of about 200 drugs, but a Sanofi spokesman said no decision has yet been made, the report noted. Reference Link
07:14 EDTISISIsis Pharmaceuticals earns $1M milestone payment from GlaxoSmithKline
Isis Pharmaceuticals (ISIS) has earned a $1M milestone payment from GlaxoSmithKline (GSK) related to the advancement of the Phase 2/3 study of ISIS-TTRRx in patients with familial amyloid polyneuropathy. ISIS-TTRRx is an antisense drug in development with GSK for the treatment of transthyretin amyloidosis, a severe and rare genetic disease characterized by progressive dysfunction of peripheral nerve and/or heart tissues. Including this milestone payment, Isis has generated $27M in upfront and milestone payments for advancing ISIS-TTRRx. If GSK elects to exercise its option to exclusively license the ISIS-TTRRx program, Isis is eligible to receive a license fee, regulatory and sales milestone payments and double-digit royalties on sales of ISIS-TTRRx.
July 9, 2014
17:02 EDTSNYRegeneron, Sanofi announce positive results from Phase 2b study of Dupilumab
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July 8, 2014
13:46 EDTSNYSanofi files patent infringement suit against Eli Lilly, Reuters says
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08:05 EDTSNYSanofi announces FDA accepted Toujeo NDA
Sanofi announced that the FDA has accepted for review the company's New Drug Application for Toujeo, an investigational basal insulin. The acceptance of the NDA follows the acceptance of the marketing authorization dossier for Toujeo by the European Medicines Agency for EU countries on May 27. The NDA for Toujeo is based on results from the EDITION clinical trial program, which is a worldwide and extensive series of Phase III studies evaluating the efficacy and safety of Toujeo in over 3,500 people.

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