Key Developments: Sanofi SA (SNY)

SNY on New York Consolidated

29 Jan 2015
Change (% chg)

$0.95 (+2.06%)
Prev Close
Day's High
Day's Low
Avg. Vol
52-wk High
52-wk Low

Search Stocks

Latest Key Developments (Source: Significant Developments)

Sanofi Genzyme's Lemtrada approved by FDA
Friday, 14 Nov 2014 08:58pm EST 

Sanofi SA:Subsidiary Genzyme announces that U.S. Food and Drug Administration (FDA) has approved Lemtrada (alemtuzumab) for treatment of patients with relapsing forms of multiple sclerosis (MS).Use of Lemtrada should generally be reserved for patients who have had inadequate response to two or more drugs indicated for treatment of MS.FDA approval of Lemtrada is based on two pivotal randomized Phase III open-label rater-blinded studies.  Full Article

Regeneron and Sanofi announces positive results from Phase 2b study of dupilumab in patients with Moderate to Severe Asthma
Tuesday, 11 Nov 2014 01:00am EST 

Regeneron Pharmaceuticals, Inc. and Sanofi SA:Announces positive results from the interim analysis of a dose-ranging Phase 2b study of dupilumab in adult patients with uncontrolled moderate-to-severe asthma.Says Dupilumab is an investigational therapy blocking IL-4 and IL-13, two cytokines required for the Th2 immune response.Elias Zerhouni, MD, President, Global R&D, Sanofi said In this study, blocking IL-4/IL-13 signaling with dupilumab improved lung function and reduced severe exacerbations in the broader study population.Says Based on these results, the company plan to move dupilumab into Phase 3 clinical development in patients with moderate-to-severe uncontrolled asthma.  Full Article

New England Journal of Medicine publishes results of final phase III efficacy clinical study of Sanofi Pasteur`s dengue vaccine candidate
Monday, 3 Nov 2014 02:45pm EST 

Sanofi SA:Says New England Journal of Medicine publishes results of final phase III efficacy clinical study of Sanofi Pasteur`s dengue vaccine candidate.Study successfully met primary objective and confirms high efficacy against severe dengue and hospitalization.Sanofi Pasteur intends to file for registration in several endemic countries in 2015.  Full Article

Sanofi Pasteur announces FDA approval of updated prescribing information for Fluzone High-Dose Vaccine for Adults 65 and Older
Monday, 3 Nov 2014 08:30am EST 

Sanofi SA:Says Sanofi Pasteur, the vaccines division, announced U.S. Food and Drug Administration (FDA) has approved the supplemental biologics license application (sBLA) for Fluzone High-Dose (Influenza Vaccine) to include efficacy data in the Prescribing Information.Data demonstrate that Fluzone High-Dose vaccine provided improved protection against influenza compared to standard-dose Fluzone vaccine (trivalent intramuscular formulation) in adults 65 years of age and older.Study found Fluzone High-Dose vaccine was 24.2 pct (95 pct CI, 9.7 to 36.5) more effective than standard-dose Fluzone vaccine in preventing laboratory-confirmed influenza caused by any influenza viral type or subtype in association with influenza-like illness, the primary endpoint.  Full Article

Sanofi SA announces senior management changes
Wednesday, 29 Oct 2014 03:58am EDT 

Sanofi SA:Says Board decided unanimously to remove Christopher A. Viehbacher as chief executive officer of Sanofi.Says as a consequence Christopher A. Viehbacher resigned as a director of Sanofi.Says the Board asked Serge Weinberg to fulfill jointly, as of Oct. 29 and on a temporary basis, the functions of chairman and chief executive officer.Says as soon as a new chief executive officer will be appointed, the Group's governance will return to a chairman and a separate chief executive officer.  Full Article

Sanofi confirms FY 2014 outlook
Tuesday, 28 Oct 2014 02:30am EDT 

Sanofi SA:Confirms to expect for FY 2014 business EPS to grow 6 to 8 pct at constant exchange rates.  Full Article

Ferring Pharmaceuticals to acquire marketing rights for DDAVP (desmopressin) product portfolio from Sanofi SA
Wednesday, 22 Oct 2014 09:00am EDT 

Ferring Pharmaceuticals:Says company has acquired DDAVP (desmopressin acetate) from Sanofi.DDAVP is available in tablets, nasal spray rhinal tube and injection.  Full Article

US FDA accepts for review a Biologics License Application for Merck and Sanofi Pasteur’s Investigational Pediatric Hexavalent Vaccine
Monday, 20 Oct 2014 08:00am EDT 

Merck & Co Inc and Sanofi Pasteur:Says the Biologics License Application (BLA) filed for the companies` investigational pediatric hexavalent vaccine, DTaP5-IPV-Hib-HepB1, has been accepted for review by the U.S. Food and Drug Administration (FDA).Says data from a Phase III study for the investigational pediatric hexavalent vaccine were recently presented at IDWeek in Philadelphia.Says this phase III study, a randomized, open-label, active-comparator controlled clinical trial with more than 1,400 infants at multiple centers across the United States, evaluated the safety and immunogenicity of the investigational pediatric hexavalent vaccine versus licensed comparator vaccines.Says the partnership between Merck and Sanofi Pasteur draws upon both companies' experience in the development, manufacturing and marketing of individual and combination vaccines.Sanofi Pasteur, is the vaccines division of Sanofi.  Full Article

Sanofi and Regeneron announce start of Phase 3 study of dupilumab in patients with atopic dermatitis
Monday, 20 Oct 2014 01:00am EDT 

Sanofi SA:Announces together with Regeneron Pharmaceuticals that first patients have been dosed in Phase 3 clinical study of dupilumab.Dupilumab is investigational therapy that blocks IL-4 and IL-13 signaling, in adults with moderate-to-severe atopic dermatitis (AD) that is not adequately controlled with topical AD medications.Trial is to enroll about 700 adult patients.LIBERTY AD Phase 3 clinical program to consist of at least five trials of patients with moderate-to-severe AD at sites worldwide.  Full Article

Sanofi Pasteur and Immune Design collaborate on vaccine to treat Herpes Simplex Virus
Thursday, 16 Oct 2014 01:00am EDT 

Sanofi SA:Says Sanofi Pasteur and Immune Design collaborate on vaccine to treat Herpes Simplex Virus.Says Sanofi Pasteur will contribute HSV-529, clinical-stage replication-defective HSV vaccine product candidate, and Immune Design will contribute G103, its preclinical trivalent vaccine product candidate.Says collaboration will explore potential of various combinations of agents, including Immune Design's GLAASTM platform, with goal to select potential immune therapy for patients.Says two companies will develop products jointly through Phase II clinical trials, at which point Sanofi Pasteur intends to continue development of most promising candidate and be responsible for commercialization.Says Sanofi Pasteur will bear costs of all preclinical and clinical development, with Immune Design providing specific formulation of GLA from the GLAAS platform at its cost through Phase II studies.Says Immune Design will be eligible to receive future milestone and royalty payments on any product developed from collaboration.Says other financial terms of agreement have not been disclosed.  Full Article


Regeneron/Sanofi cholesterol drug gets FDA priority review

- Regeneron Pharmaceuticals on Monday said U.S. health regulators accepted its application to review a potent cholesterol drug on a priority basis, potentially giving it the upper hand in a fierce race with Amgen to bring a new medicine from the promising class to market.

Search Stocks