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Sanofi SA (SASY.BE)

SASY.BE on Berlin Stock Exchange

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24 May 2017
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Latest Key Developments (Source: Significant Developments)

Regeneron, Sanofi RA drug wins FDA nod; co's price it at $39,000/patient/yr
Monday, 22 May 2017 05:45pm EDT 

May 22 (Reuters) - Sanofi Sa :Regeneron and sanofi announce fda approval of kevzara® (sarilumab) for the treatment of moderately to severely active rheumatoid arthritis in adult patients.Regeneron pharmaceuticals inc - in u.s., kevzara will be marketed by regeneron and sanofi genzyme, specialty care global business unit of sanofi.Regeneron pharmaceuticals, inc says in clinical trial program, sarilumab was statistically significant.Regeneron - final decision on marketing authorization application for kevzara in european union will be made by european commission in coming months.Regeneron pharmaceuticals inc - u.s. Wholesale acquisition cost of kevzara is $39,000/year for 200 mg and 150 mg doses.  Full Article

Sanofi receives CHMP recommendation for approval of insulin lispro biosimilar
Friday, 19 May 2017 07:09am EDT 

May 19 (Reuters) - SANOFI SA :REG-SANOFI RECEIVES CHMP RECOMMENDATION FOR APPROVAL OF INSULIN LISPRO BIOSIMILAR.POSITIVE OPINION BASED ON A CLINICAL DEVELOPMENT PROGRAM INVOLVING OVER 1,000 PEOPLE WITH TYPE 1 OR TYPE 2 DIABETES.EUROPEAN COMMISSION IS EXPECTED TO MAKE A FINAL DECISION ON MARKETING AUTHORIZATION FOR INSULIN LISPRO SANOFI(® )IN COMING MONTHS.  Full Article

Frontier IP announces 250 mln euro licence option agreement with Sanofi
Tuesday, 9 May 2017 06:50am EDT 

May 9 (Reuters) - Frontier IP Group Plc ::Exscientia announces 250 mln euro collaboration for a multiple-product development and licence option agreement with Sanofi.  Full Article

Regeneron and Sillajen report immuno-oncology clinical study agreement
Monday, 8 May 2017 08:30am EDT 

May 8 (Reuters) - Sillajen Inc <215600.KQ>::Regeneron and Sillajen announce immuno-oncology clinical study agreement for combination treatment in kidney cancer.Regeneron - phase 1b clinical trial will evaluate combination of regeneron's pd-1 inhibitor regn2810 and Sillajen's pexa-vec, an oncolytic virus.Regeneron Pharmaceuticals - under terms of agreement, trial will be solely conducted, funded by sillajen based upon mutually developed study design.Regeneron Pharmaceuticals Inc - co, Sanofi is developing regn2810 both alone and in combination with other therapies for treatment of various cancers.Regeneron Pharmaceuticals- open-label trial for phase 1b dose-escalation study is expected to begin later this year.Regeneron Pharmaceuticals- phase 1b dose-escalation study will initially open in Korea, with expansion to sites in U.S..  Full Article

Regeneron and Inovio enter immuno-oncology clinical study agreement
Monday, 8 May 2017 07:30am EDT 

May 8 (Reuters) - Inovio Pharmaceuticals Inc : :Regeneron and Inovio enter immuno-oncology clinical study agreement for glioblastoma combination therapy.Regeneron Pharmaceuticals Inc - study will be conducted by inovio in patients with newly-diagnosed glioblastoma multiforme.Regeneron-Study to evaluate co's pd-1 inhibitor, regn2810, with Inovio's ino-5401 t cell activating immunotherapy encoding multiple antigens and ino-9012.Regeneron - trial will be solely conducted and funded by inovio, based upon a mutually agreed upon study design, and regeneron will supply regn2810.Regeneron Pharmaceuticals Inc - Inovio and regeneron will jointly conduct immunological analyses in support of study.Regeneron Pharmaceuticals Inc - Regeneron, in collaboration with Sanofi, is developing regn2810 both alone and in combination with other therapies.  Full Article

Sanofi Genzyme announces approval of Cerdelga by Health Canada for rare genetic condition
Monday, 1 May 2017 08:00am EDT 

May 1 (Reuters) - Sanofi Sa :Sanofi genzyme announces approval of cerdelga (eliglustat capsules) by health canada for rare genetic condition.  Full Article

Regeneron and Sanofi announce Kevzara license application resubmission for review by FDA
Friday, 28 Apr 2017 01:00am EDT 

April 28 (Reuters) - Sanofi :Regeneron and Sanofi announce Kevzara® (sarilumab) Biologics License Application resubmission accepted for review by U.S. FDA.Per Prescription Drug User Fee Act (PDUFA), new target action date is May 22, 2017.European Commission expected to make a final decision on marketing authorization application for Kevzara in EU in coming months.  Full Article

Sanofi and Regeneron announce FDA approval of a once-monthly dosing option for Praluent
Tuesday, 25 Apr 2017 08:00am EDT 

April 25 (Reuters) - Sanofi :Sanofi and Regeneron announce FDA approval of a new once-monthly dosing option for Praluent (alirocumab) injection.Sanofi and Regeneron announce FDA approval of a new once-monthly dosing option for Praluent (alirocumab) injection.Monthly dosing schedule now approved in both United States and European Union.  Full Article

Regeneron says FDA approved for praluent injection
Tuesday, 25 Apr 2017 08:00am EDT 

April 25 (Reuters) - Regeneron Pharmaceuticals Inc -:Regeneron and Sanofi announce FDA approval of a new once-monthly dosing option for Praluent (Alirocumab) injection.Regeneron and Sanofi announce FDA approval of a new once-monthly dosing option for Praluent (Alirocumab) injection.  Full Article

Sanofi receives FDA approval of Thymoglobulin for prevention of acute kidney transplant rejection
Monday, 24 Apr 2017 08:30am EDT 

April 24 (Reuters) - Sanofi SA ::Sanofi receives FDA approval of Thymoglobulin® for the prevention of acute kidney transplant rejection.Sanofi- FDA approved thymoglobulin for use in conjunction with concomitant immunosuppression in prophylaxis of acute rejection in patients receiving kidney transplant.  Full Article

More From Around the Web

UPDATE 1-Regeneron, Sanofi rheumatoid arthritis drug wins U.S. approval

May 22 The U.S. Food and Drug Administration approved Regeneron Pharmaceuticals Inc and Sanofi SA's biotech drug for adults with moderate to severe rheumatoid arthritis, the two companies said on Monday.