Key Developments: Sanofi SA (SASY.PA)

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Latest Key Developments (Source: Significant Developments)

Sanofi and Regeneron announce new data from positive phase 3 trial of sarilumab in rheumatoid arthritis
Thursday, 12 Jun 2014 01:02am EDT 

Sanofi SA:Sanofi and Regeneron Pharmaceuticals Inc present positive results from phase 3 trial of investigational drug sarilumab in rheumatoid arthritis (RA) patients who were inadequate responders to methotrexate (MTX) therapy.New data showed that sarilumab increased clinical response rates defined as achieving ACR70 for at least 24 consecutive weeks and showed sustained improvement in signs and symptoms of RA after 52 weeks, which were secondary endpoints of trial.In this study, called SARIL-RA-MOBILITY, sarilumab met all three co-primary endpoints, demonstrating improvement in disease signs and symptoms at 24 weeks, physical function at 16 weeks and inhibition of joint damage progression at 52 weeks.Patients were randomized to one of three treatment groups dosed subcutaneously every other week, sarilumab 150 milligrams (mg), sarilumab 200 mg, or placebo, all in combination with MTX.Both sarilumab groups showed statistically improvements compared to placebo group in all three co-primary endpoints (p < 0.0001): improvement in signs and symptoms of RA at 24 weeks, improvement in physical function at Week 16 and inhibition of progression of structural damage at Week 52.  Full Article

Sanofi Genzyme's Lemtrada resubmission accepted for review by FDA
Friday, 30 May 2014 02:15am EDT 

Sanofi SA:Subsidiary Genzyme says U.S. Food and Drug Administration (FDA) has accepted for review company's resubmission of its supplemental Biologics License Application (sBLA) seeking approval of Lemtrada (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis.Six-month review period assigned for Lemtrada sBLA.Genzyme expects FDA action on sBLA in Q4.Resubmission is based on data from same clinical studies included in original sBLA, and provides supplemental analyses and additional information to specifically address issues previously noted by FDA.  Full Article

Sanofi SA and Eli Lilly announce licensing agreement for Cialis (tadalafil) OTC
Wednesday, 28 May 2014 12:08am EDT 

Sanofi SA and Eli Lilly and Co:Agreement to pursue regulatory approval of nonprescription Cialis (tadalafil).Cialis is currently available by prescription only worldwide for treatment of men with erectile dysfunction.Under terms of agreement, Sanofi acquires exclusive rights to apply for approval of Cialis OTC in US, Europe, Canada and Australia.Sanofi also holds exclusive rights to market Cialis OTC following Sanofi's receipt of all necessary regulatory approvals.If approved, Sanofi anticipates providing Cialis OTC after expiration of certain patents.  Full Article

Sanofi SA announces favorable Phase II study results for investigational Clostridium difficile Vaccine
Monday, 19 May 2014 08:01am EDT 

Sanofi SA:Says its Sanofi Pasteur, the vaccines division presented Phase II trial (H-030-012) results for an investigational vaccine for the prevention of Clostridium difficile.The Phase II trial met its primary objectives, reactions were generally mild and of short duration, and the candidate vaccine generated an immune response against C. diff toxins A and B.  Full Article

Sanofi SA's pentavalent pediatric vaccine pre qualified by World Health Organization
Monday, 5 May 2014 01:15am EDT 

Sanofi SA:Says that its pediatric pentavalent vaccine Shan5, developed and manufactured by its affiliate Shantha Biotechnics in Hyderabad, India, has received prequalification status from the World Health Organization.This status is based on a review of a comprehensive set of data related to the process and the product characteristics, as well as on a positive recommendation of WHO's auditors following a site inspection of Shantha's manufacturing facilities.It qualifies Shan5 vaccine for purchase by United Nations agencies, mainly UNICEF.Shan5 prequalification will give more children around the world access to the latest fully-liquid, 5-in-1 vaccine.And help secure the supply of pentavalent combination vaccines in over 50 emerging and low-income countries.  Full Article

Sanofi and Genzyme announce new MRI data from Lemtrada clinical development program
Wednesday, 30 Apr 2014 10:30am EDT 

Sanofi SA:Sanofi and its subsidiary Genzyme announce new magnetic resonance imaging (MRI) data from the Lemtrada (alemtuzumab) clinical development program.In Lemtrada patients from two Phase III clinical trials (both treatment-naive patients and patients who had active disease on another therapy), MRI effects observed after two years were maintained during first year of extension study.Consistent effects were seen across key measures of disease activity (gadolinium (gd)-enhancing, T2 hyperintense and T1 hypointense lesion activity) and effects seen after two years of treatment were sustained at year three.During third year of follow-up, more than 70 pct of patients were free of MRI activity indicative of acute inflammation, defined as gd-enhancing or new or enlarging T2 hyperintense lesions.T2 lesion volumes, which reflect combined burden of permanent brain injury and new lesion formation, increased from year two to three but remained below pre-treatment baseline.Atrophy rate, as measured by brain parenchymal fraction, already reduced after two years, continued to slow in third year of follow-up.About 80 pct of patients treated with Lemtrada did not receive third course of treatment in first year of extension.  Full Article

Sanofi confirms FY 2014 outlook
Tuesday, 29 Apr 2014 01:31am EDT 

Sanofi SA:Continues to expect FY 2014 business EPS in growth of between 4 pct and 7 pct at CER.  Full Article

First Phase III study of Sanofi Pasteur dengue vaccine candidate achieves primary endpoint
Monday, 28 Apr 2014 01:02am EDT 

Sanofi SA:Vaccines division Sanofi Pasteur announces that first of two pivotal Phase III efficacy studies with its dengue vaccine candidate has achieved its primary clinical endpoint.Efficacy study showed reduction of 56 pct of dengue disease cases.Initial safety data consistent with safety profile observed in previous studies.Full analysis of data to be undertaken in subsequent weeks and reviewed by external experts prior to disclosure at upcoming international scientific congress and publication in a peer-reviewed journal.Results to be further complemented by results in Q3 2014 from second study being conducted in Latin America, including more than 20,000 volunteers from Brazil, Colombia, Honduras, Mexico and Puerto Rico.  Full Article

Aastrom Biosciences Inc to acquire Sanofi 's Cell Therapy and Regenerative Medicine Business
Monday, 21 Apr 2014 08:31am EDT 

Aastrom Biosciences Inc:Agreement to acquire Sanofi's Cell Therapy and Regenerative Medicine (CTRM) business.Purchase price of $6.5 mln, with $4 mln payable in cash at closing and $2.5 mln payable in form of a promissory note.  Full Article

Sanofi and Merck vaccines JV initiates legal proceedings against Spain's Ministry of Health-IHS Global Insight Daily Analysis
Wednesday, 16 Apr 2014 08:00pm EDT 

Sanofi SA:Sanofi and Merck & Co's vaccines joint venture Sanofi Pasteur MSD initiates legal proceedings against Spain's Ministry of Health (MoH) for blocking the sale of the chickenpox vaccine Varivax in pharmacies - IHS Global Insight Daily Analysis.Initiative follows on from claims by Spanish Association of Pharmacists (FEFE) that MoH's decision to withhold chickenpox vaccines from pharmacies is arbitrary and has no legal basis.MoH claims that chickenpox is being over-vaccinated in Spain.  Full Article

IATA seeks meeting with Venezuela president over money owed to airlines

BERLIN, July 28 - A leading air transport industry body has called for a top-level meeting with the Venezuelan president to discuss ways to restore over $4 billion of airlines' money that is trapped in the country due to its currency controls.

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