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News Breaks
December 14, 2012
07:31 EDTISIS, SNYGenzyme, Isis say CHMP adopts negative opinion on KYNAMRO MAA
Genzyme, a Sanofi company (SNY), and Isis Pharmaceuticals (ISIS), announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a negative opinion for its marketing authorization application for KYNAMRO for the treatment of patients with Homozygous Familial Hypercholesterolaemia. Genzyme plans to request a re-examination of the CHMP Opinion. An application for KYNAMRO is currently under review by the U.S. Food and Drug Administration. In October, KYNAMRO received a positive vote by an FDA advisory panel that Genzyme had provided sufficient efficacy and safety data to support the marketing of KYNAMRO for the treatment of patients with Homozygous Familial Hypercholesterolaemia.
News For SNY;ISIS From The Last 14 Days
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February 26, 2015
15:30 EDTISISNotable companies reporting before tomorrow's open
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05:32 EDTSNYSanofi receives FDA approval of once-daily basal insulin Toujeo
Sanofi announced that the FDA approved Toujeo, a once-daily long-acting basal insulin, to improve glycemic control in adults living with type 1 and type 2 diabetes. Toujeo is expected to be available in the U.S. at the beginning of Q2. The approval of Toujeo was based on FDA review of results from the EDITION clinical trial program, which was comprised of a series of international Phase III studies evaluating the efficacy and safety of Toujeo in more than 3,500 adults from broad and diverse diabetes populations.
February 25, 2015
20:05 EDTSNYSanofi receives FDA approval of once-daily basal insulin Toujeo
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February 24, 2015
10:48 EDTISISIsis says ISIS-PKKRx reduced prekallikrein levels in Phase 1 study
Isis Pharmaceuticals announced results from a Phase 1 study with ISIS-PKKRx. In this study, healthy volunteers treated with ISIS-PKKRx achieved dose-dependent reductions of up to 95% in prekallikrein, or PKK, Isis said. ISIS-PKKRx is a RNA-targeted antisense drug designed to inhibit the production of PKK for the prophylactic treatment of hereditary angioedema. ISIS-PKKRx was evaluated in single and multiple doses ranging from 50 mg per week up to 400 mg per week for the single dose and 100 mg up to 400 mg for the multiple doses. After three weeks of dosing, subjects in the 100, 200, 300 and 400 mg multiple-dose cohorts displayed a mean reduction of PKK of 33, 69, 87 and 92%, respectively, from baseline. In this study, ISIS-PKKRx was generally well tolerated.
February 23, 2015
07:22 EDTISISSunTrust to hold a conference
2015 Biotechnology and Pharmaceutical 1:1 Orphan Drug Day is being held in New York on February 23.
February 20, 2015
15:20 EDTISISIsis Pharmaceuticals management to meet with JPMorgan
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07:08 EDTSNYAmerican Academy of Allergy, Asthma and Immunology to hold annual meeting
2015 Annual Meeting of AAAAI is being held in Houston, Texas on February 20-24.
February 19, 2015
16:50 EDTSNYSanofi appoints Olivier Brandicourt CEO
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09:59 EDTSNYOn The Fly: Analyst Upgrade Summary
Today's noteworthy upgrades include: Altisource Residential (RESI) upgraded to Neutral from Sell at Compass Point... Angie's List (ANGI) upgraded to Overweight from Equal-Weight at First Analysis... Barrick Gold (ABX) upgraded to Buy from Hold at TD Securities... British Land (BTLCY) upgraded to Buy from Hold at Societe Generale... Coach (COH) upgraded to Buy from Hold at Topeka... Fiat Chrysler (FCAU) upgraded to Outperform from Neutral at Exane BNP Paribas... Garmin (GRMN) upgraded at BofA/Merrill... Hologic (HOLX) upgraded to Buy from Hold at Canaccord... Iberdrola (IBDRY) upgraded to Neutral from Underweight at HSBC... KPN (KKPNY) upgraded to Neutral from Underperform at Exane BNP Paribas... Monster Worldwide (MWW) upgraded at Evercore ISI... Pharmacyclics (PCYC) upgraded to Buy from Neutral at Nomura... RPC, Inc. (RES) upgraded to Equal Weight from Underweight at Morgan Stanley... Sanofi (SNY) upgraded to Buy from Neutral at BofA/Merrill... Sasol (SSL) upgraded to Neutral from Underweight at HSBC... Tractor Supply (TSCO) upgraded at Oppenheimer... Valero (VLO) upgraded to Buy from Hold at Deutsche Bank... Weingarten Realty (WRI) upgraded to Neutral from Sell at UBS... Werner (WERN) upgraded on improving freight fundamentals at RBC Capital... diaDexus (DDXS) upgraded to Buy from Neutral at Ladenburg,
06:21 EDTSNYSanofi upgraded to Buy from Neutral at BofA/Merrill
05:31 EDTSNYSanofi upgraded to Buy from Neutral at BofA/Merrill
February 17, 2015
11:38 EDTSNYGenzyme reports publication of ENGAGE registration study results
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