Key Developments: Sanofi SA (SASY.PA)

SASY.PA on Paris Stock Exchange

24 Dec 2014
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Latest Key Developments (Source: Significant Developments)

Sanofi SA subsidiary acquires two equine health products from Bayer AG
Tuesday, 16 Dec 2014 07:00pm EST 

Sanofi SA:Announces that its animal health company, Merial, Inc., has reached an agreement with Bayer HealthCare, a subsidiary of Bayer AG, to purchase two Bayer equine health products, Legend/Hyonate (hyaluronate sodium) and Marquis (ponazuril).  Full Article

Evotec and Sanofi enter into exclusive negotiations for major multi-component strategic collaboration
Tuesday, 2 Dec 2014 12:05pm EST 

Evotec AG:Says Evotec and Sanofi will collaborate on pre-clinical development project initiatives with an initial focus on oncology.Says Evotec and Sanofi will enter into an outsourcing alliance and Evotec will acquire Sanofi's scientific operations in toulouse.Says Evotec and Sanofi will combine their compound libraries and make them available for screening projects to Evotec's partners.Says collaboration will result in a minimum guaranteed commitment from Sanofi to Evotec of 250 million euros over next five years.Says Evotec will also be entitled to milestone and royalty rights on some potential products.Says transaction is expected to be signed in first half of 2015.  Full Article

Sanofi SA gets US approval for use of Priftin drug in latent TB-Reuters
Monday, 1 Dec 2014 07:00pm EST 

Sanofi SA:Says that the U.S. Food and Drug Administration has approved its Priftin (rifapentine) drug in combination with isoniazid (INH) for a new indication, in the treatment of latent tuberculosis infection-Reuters.Says the oral drug, first approved in the United States in 1998 to treat active pulmonary TB, can now be prescribed to patients over two years old and at high risk of developing the disease.  Full Article

Regeneron Pharmaceuticals, Inc. and Sanofi SA receives FDA therapy designation in Atopic Dermatitis
Thursday, 20 Nov 2014 01:30am EST 

Regeneron Pharmaceuticals, Inc. and Sanofi SA:Says that the U.S. Food and Drug Administration has granted Therapy designation to dupilumab for the treatment of adults with moderate-to-severe atopic dermatitis who are not adequately controlled with topical prescription therapy and/or for whom these treatments are not appropriate.Dupilumab is an investigational therapy blocking IL-4 and IL-13, two cytokines required for the Th2 immune response.Says the designation is based on positive results from Phase 1 and 2 clinical trials.  Full Article

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

TRLPC-Sanofi agrees 8 bln euro loan refinancing

LONDON, Dec 17 - French drugmaker Sanofi has completed an 8 billion euro refinancing of its two syndicated revolving credit facilities, the company said in an email on Wednesday.

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