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Sanofi SA (SASY.PA)

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Latest Key Developments (Source: Significant Developments)

Aimmune Therapeutics collaborates to study AR101 with Regeneron and Sanofi’s dupilumab for peanut allergy
Monday, 16 Oct 2017 07:30am EDT 

Oct 16 (Reuters) - Aimmune Therapeutics Inc : :Aimmune Therapeutics announces clinical collaboration to study AR101 with Regeneron and Sanofi’s dupilumab for peanut allergy.Aimmune Therapeutics Inc - ‍regeneron will sponsor trial, with Aimmune to provide clinical supply of AR101 and food challenge materials​.Aimmune Therapeutics Inc - ‍clinical collaboration will include formation of an Aimmune-Regeneron/Sanofi joint development committee​.Aimmune Therapeutics Inc - ‍planned phase 2 clinical trial to study AR101 is expected to begin in 2018​.Aimmune Therapeutics Inc - ‍trial design will test potential to achieve sustained unresponsiveness to peanut following treatment​.  Full Article

U.S. Appellate Court rules Sanofi, Regeneron can continue manufacturing PRALUENT in U.S.
Thursday, 5 Oct 2017 12:30pm EDT 

Oct 5 (Reuters) - Sanofi SA ::Appellate Court orders a new trial and vacates permanent injunction in ongoing patent case regarding Praluent® (alirocumab).‍Sanofi - co and Regeneron do not anticipate any new trial proceedings to start in 2017.Sanofi says U.S. Court of Appeals ruling means that co, Regeneron will continue marketing, selling, manufacturing Praluent (alirocumab) injection in U.S.‍Sanofi - Court has ordered new trial, vacated permanent injunction in dispute concerning Amgen's asserted patent claims for antibodies targeting PCSK9​.  Full Article

Novo Nordisk gets positive opinion for label update in EU for Tresiba
Friday, 29 Sep 2017 10:06am EDT 

Sept 29 (Reuters) - NOVO NORDISK SAYS:THE COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE UNDER THE EUROPEAN MEDICINES AGENCY (EMA) HAS ENDORSED AN UPDATE OF THE EU LABEL WITH IMMEDIATE EFFECT FOR TRESIBA TO INCLUDE RESULTS FROM THE DEVOTE TRIAL ON SEVERE HYPOGLYCAEMIA.DEVOTE IS A RANDOMISED, MULTINATIONAL AND DOUBLE-BLINDED TRIAL CONDUCTED TO CONFIRM THE CARDIOVASCULAR SAFETY OF TRESIBA COMPARED TO INSULIN GLARGINE U100 WHEN ADDED TO STANDARD OF CARE, IN PEOPLE WITH TYPE 2 DIABETES.IN THE TRIAL, THE PRIMARY ENDPOINT WAS ACHIEVED BY DEMONSTRATING NON-INFERIORITY OF MAJOR ADVERSE CARDIOVASCULAR EVENTS WITH TRESIBA COMPARED TO INSULIN GLARGINE U100.  Full Article

Thermalin collaborates with Sanofi to develop insulin therapies
Thursday, 28 Sep 2017 10:38am EDT 

Sept 28 (Reuters) - Thermalin::Thermalin announces: collaboration with Sanofi to develop next generation insulin therapies.Says worldwide collaboration with Sanofi to discover and develop novel, engineered insulin analogues​.Says Sanofi will assume clinical development costs of insulin programs and pay royalties on commercial sales of products​.  Full Article

Innovation Health announces pilot program with Sanofi to improve care delivery for people living with type 2 diabetes
Monday, 25 Sep 2017 09:00am EDT 

Sept 25 (Reuters) - Innovation Health: :Innovation Health announces pilot program with Sanofi to improve care delivery for people living with type 2 diabetes.Innovation-Program will work to study impact of novel digital health solutions from one drop and gocap to help patient outcomes, medication adherence.  Full Article

Alnylam's genetic disease drug meets main goal in phase 3 study
Wednesday, 20 Sep 2017 06:59am EDT 

Sept 20 (Reuters) - Alnylam Pharmaceuticals Inc :Sanofi and Alnylam report positive topline results from APOLLO phase 3 study of patisiran in Hereditary ATTR (HATTR) amyloidosis patients with polyneuropathy.Alnylam Pharmaceuticals Inc - intends to file new drug application (NDA) in late 2017 and marketing authorisation application (MAA) in early 2018‍​.Alnylam Pharmaceuticals - ‍​investigational RNAI therapeutic patisiran meets primary and all secondary endpoints.Alnylam Pharmaceuticals Inc - "overall safety profile of patisiran was encouraging"‍​.Alnylam Pharmaceuticals- all five other secondary endpoints demonstrated statistically significant favorable differences in patisiran arm versus placebo ‍​.Alnylam Pharmaceuticals - in trial, at 18 months, mean change from baseline in MNIS+7 was significantly lower in patisiran group versus placebo‍​.  Full Article

Daily blood glucose measures in phase 3 clinical trials showed better stability with Sanofi's toujeo vs insulin glargine 100 units/ml
Wednesday, 13 Sep 2017 07:01am EDT 

Sept 13 (Reuters) - Sanofi SA :Daily blood glucose measures in phase 3 clinical trials demonstrated better stability with Sanofi's toujeo versus insulin glargine 100 units/ml.Sanofi - ‍improvements in blood glucose stability were statistically significant in edition 2 and senior, and for night-time measurements in edition 3​.  Full Article

Sanofi says receives tentative FDA approval of Admelog
Friday, 1 Sep 2017 02:00pm EDT 

Sept 1 (Reuters) - Sanofi Sa : :Sanofi receives tentative FDA approval of Admelog® (insulin lispro injection) 100 units/ml.Sanofi - ‍With tentative approval, FDA concluded that Admelog met all necessary regulatory requirements for approval in U.S.​.  Full Article

Sanofi completes the acquisition of Protein Sciences
Monday, 28 Aug 2017 01:20am EDT 

Aug 28 (Reuters) - Sanofi ::* Completed the acquisition of Protein Sciences, a vaccines biotechnology company based in Meriden, Connecticut in the United States.* Sanofi said in July that it would buy Protein Sciences for an initial amount of $650 million nASM000CSF.  Full Article

Paulson & Co cuts share stake in Teva Pharmaceutical, Sanofi
Monday, 14 Aug 2017 05:10pm EDT 

Aug 14 (Reuters) - Paulson & Co:Paulson & Co Inc cuts share stake in Teva Pharmaceutical Industries Ltd by 38.7 percent to 6.7 million sponsored ADR - SEC filing.Paulson & Co Inc cuts share stake in Sanofi by 65.3 percent to 52,000 sponsored ADR.Paulson & Co Inc - Change in holdings are as of June 30, 2017 and compared with the previous quarter ended as of March 31, 2017.  Full Article

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China biotech's 'coming out party' masks long road ahead

LONDON/SHANGHAI Investors are betting on China's potential to feed the global pharmaceutical pipeline, putting a multi-billion-dollar price tag on a handful of stocks, even as the country struggles to close a huge R&D gap with the West.