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Sanofi SA (SASY.BE)

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Latest Key Developments (Source: Significant Developments)

Vivus reacquires Stendra(R)(AVANAFIL)commercial rights from Sanofi
8:30am EDT 

Vivus Inc : Reacquires Stendra(R) (Avanafil) commercial rights from Sanofi . Says Sanofi will provide transition services to avoid adverse impacts to regulatory approval applications in process .Agreement with Sanofi to return commercial rights for Stendra in Africa, Middle East, Turkey, Commonwealth Of Independent States, including Russia, to Co.  Full Article

Sanofi and Voluntis announce a global alliance to deliver digital insulin titration solutions for people with type 2 diabetes
Tuesday, 14 Mar 2017 05:46am EDT 

Sanofi Sa : Sanofi and Voluntis announce a global alliance to deliver digital insulin titration solutions for people with type 2 diabetes .Voluntis - Sanofi and Voluntis will launch pilot programs using mobile phone application in North America and several European countries.  Full Article

UK regulator gives positive opinion on Sanofi/Regeneron's dupilumab product
Tuesday, 14 Mar 2017 04:30am EDT 

Sanofi : Sanofi says UK's Medicines & Healthcare Products Regulatory Agency (MHRA) has granted dupilumab, a product which treats for atopic dermatitis (AD), a positive scientific opinion through the Early Access to Medicines Scheme (EAMS). . The decision means that eligible adults with severe atopic dermatitis can access dupilumab before the drug is granted marketing authorisation in the UK, Sanofi adds in statement .Dupilumab is currently under joint development with Regeneron and Sanofi and its safety and efficacy have not been fully evaluated by any regulatory body. The formal EU regulatory application for dupilumab is currently under review by the European Medicines Agency (EMA)..  Full Article

Regeneron and Sanofi to present new phase 3 praluent (alirocumab) injection clinical trial analyses at ACC.17 Scientific Sessions
Tuesday, 7 Mar 2017 08:00am EST 

Regeneron Pharmaceuticals Inc : Regeneron and Sanofi to present new phase 3 praluent (alirocumab) injection clinical trial analyses at ACC.17 Scientific Sessions .Regeneron Pharmaceuticals Inc says effect of praluent on cardiovascular (CV) morbidity and mortality has not yet been determined.  Full Article

Sanofi Pasteur and Medimmune collaborate on monoclonal antibody to prevent illnesses associated with RSV
Friday, 3 Mar 2017 02:00am EST 

Sanofi : Sanofi Pasteur and Medimmune [MEDI.UL] collaborate on monoclonal antibody to prevent illnesses associated with RSV . Sanofi Pasteur will make an upfront payment of 120 million euros and pay up to 495 million euros upon achievement of certain development and sales-related milestones . Two companies will share all costs and profits equally . Medimmune will continue to lead all development activity up to first approval, and AstraZeneca will retain medi8897 manufacturing activities .Sanofi Pasteur will lead commercialization activities for medi8897.  Full Article

Sanofi Genzyme says kevzara now available in Canada for treatment of adult patients with moderately to severely active rheumatoid arthritis
Tuesday, 28 Feb 2017 08:00am EST 

Sanofi SA :Sanofi Genzyme - kevzara now available in Canada for treatment of adult patients with moderately to severely active rheumatoid arthritis.  Full Article

FTC approves final order settling charges for Boehringer Ingelheim’s asset swap with Sanofi
Friday, 24 Feb 2017 01:47pm EST 

U.S. Federal Trade Commission (FTC) :U.S. FTC - Approved final order settling charges that Boehringer Ingelheim’s $13.53 billion asset swap with Sanofi would likely be anticompetitive.  Full Article

Ipsen acquires a portfolio of select consumer healthcare products from Sanofi
Monday, 13 Feb 2017 01:52am EST 

Ipsen SA : Ipsen to acquire a portfolio of select consumer healthcare products from Sanofi . Ipsen to pay 83 million euros ($88.24 million) cash upon closing for products . Transaction, which is subject to customary closing conditions, including european commission's approval, is expected to close in Q2 of 2017 .Transaction will be fully financed by Ipsen's existing cash and lines of credit.  Full Article

Regeneron says price increases unrelated from innovation will be pushed back on
Thursday, 9 Feb 2017 09:00am EST 

Regeneron Pharmaceuticals Inc - : Regeneron CEO: "As we further diversify our product related revenue stream, we do not plan to provide eylea guidance after 2017" . Regeneron CEO says Amgen's asserted patent claims on repatha are invalid and we look forward to pursuing our appeal over the coming months: conf call . Regeneron's Bob Terifay says Eylea will continue for co over the years to come . Regeneron: Eylea sales growth has slowed reflecting normal market dynamics for the product that has been around for over 5 yrs with no price hike since launch . Regeneron CEO says changes in pharmaceutical drug pricing will need congressional action . Regeneron CEO "Price increases that are unrelated or uncoupled from innovation will be pushed back on" . Regeneron CEO: Constant price increases & magnitude of them are reflection of tone deafness on those taking hikes & complexities about how rebates work . Regeneron CEO: "There is an opportunity to come up with more responsible pricing", in relation to rheumatoid arthritis drug, sarilumab . Regeneron CEO: "Pharma is running around saying the middleman (PBM) is taking too much; the middleman says prices are too high and patients are wondering what is really going on" . Regeneron CEO: "price increases are nice but if you cannot get them you better be able to innovate and that is our sweet spot" Further company coverage: [AMGN.O] ((bangalore.newsroom@thomsonreuters.com;)).  Full Article

Regeneron posts Q4 adj. profit $3.04/shr
Thursday, 9 Feb 2017 06:32am EST 

Regeneron Pharmaceuticals Inc : Regeneron reports fourth quarter and full year 2016 financial and operating results . Regeneron Pharmaceuticals Inc - Q4 2016 eylea global net sales increased 17 pct to $1.35 billion versus Q4 2015 . Regeneron Pharmaceuticals Inc - in Q4 of 2016, global net sales of praluent were $41 million, compared to $7 million in Q4 of 2015 . Says net product sales were $863 million in Q4, compared to $750 million . Regeneron Pharmaceuticals Inc - total revenues increased by 12 pct to $1.227 billion in Q4 of 2016 . Regeneron Pharmaceuticals Inc - sees 2017 Sanofi reimbursement of Regeneron commercialization-related expenses of $400 million - $450 million . Regeneron Pharmaceuticals Inc qtrly non-GAAP net income per share $3.04 . Qtrly GAAP net income per share $2.19 . Q4 earnings per share view $3.03, revenue view $1.30 billion -- Thomson Reuters I/B/E/S . Regeneron Pharmaceuticals Inc - sees single digit percentage growth over 2016 for eylea U.S. net product sales in 2017 . Regeneron Pharmaceuticals Inc - "also studying dupixent in patients with nasal polyps and pediatric patients with asthma or atopic dermatitis" . Regeneron - dupixent may have potential to help additional patients with serious allergic diseases, Phase 3 data in adult asthma patients expected later this year . Regeneron Pharmaceuticals Inc - pre-approval inspection for dupixent has been scheduled for Q1 of 2017.  Full Article

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