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Wed, 05 Sep 2018 14:10:19 -0000 Global biopharmaceutical company, Sanofi, has reached a civil settlement with the US Securities and Exchange Commission (SEC), leading to a full resolution of the commission’s investigation into the company https://www.epmmagazine.com/news/sanofi-reaches-civil-settlement-with-the-us-sec/ https://www.epmmagazine.com/news/sanofi-reaches-civil-settlement-with-the-us-sec/ Wed, 05 Sep 2018 14:10:19 -0000 settlement Sanofi Genzyme — specialty care global business unit of French pharma company Sanofi — has launched its multiple sclerosis (MS) drug in India, however, according to GlobalData, it should be cautious of fierce generic competition… https://www.epmmagazine.com/news/sanofi-genzymes-should-be-cautious-about-indian-pricing/ https://www.epmmagazine.com/news/sanofi-genzymes-should-be-cautious-about-indian-pricing/ Tue, 28 Aug 2018 13:52:50 -0000 India Cablivi (caplacizumab) has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for the treatment of a rare blood-clotting disorder, acquired thrombotic thrombocytopenic purpura (aTTP) https://www.epmmagazine.com/news/chmp-gives-positive-opinion-for-treatment-of-rare-blood-clot/ https://www.epmmagazine.com/news/chmp-gives-positive-opinion-for-treatment-of-rare-blood-clot/ Mon, 02 Jul 2018 12:35:54 -0000 Approval Sanofi and Advent International have finalised negotiations for the acquisition of Zentiva — Sanofi’s European generics business — with both companies signing a Share Purchase Agreement worth €1.9 billion. https://www.epmmagazine.com/news/negotiations-finalised-for-acquisition-of-zentiva/ https://www.epmmagazine.com/news/negotiations-finalised-for-acquisition-of-zentiva/ Thu, 28 Jun 2018 11:29:17 -0000 Negotiations Sanofi has acquired all outstanding shares, warrants and convertible bonds of Ablynx, following the expiration of the squeeze-out procedure. https://www.epmmagazine.com/news/sanofi-completes-acquisition-of-ablynx/ https://www.epmmagazine.com/news/sanofi-completes-acquisition-of-ablynx/ Wed, 20 Jun 2018 12:24:39 -0000 Acquisition Felicity Thomas A brief round-up of some of the developments in the industry including a step in the right direction for oral insulin and an overview of Alantra Pharma’s Fast 50 index… https://www.epmmagazine.com/opinion/a-small-dose-june-2018/ https://www.epmmagazine.com/opinion/a-small-dose-june-2018/ Fri, 15 Jun 2018 13:59:09 -0000 A small dose CDMO, Recipharm, has acquired Sanofi’s manufacturing centre and business located in Holmes Chapel, which will provide the company with a platform to take advantage of the growing respiratory drug market. https://www.epmmagazine.com/news/recipharm-acquires-sanofis-holmes-chapel-manufact-centre/ https://www.epmmagazine.com/news/recipharm-acquires-sanofis-holmes-chapel-manufact-centre/ Thu, 14 Jun 2018 11:50:16 -0000 Acquisition Biopharmaceutical companies, Sanofi and Ablynx, have announced the successful results of the initial tender offer period for Sanofi to acquire outstanding shares of Ablynx. https://www.epmmagazine.com/news/sanofi-ablynx-announce-success-of-initial-tender-offer/ https://www.epmmagazine.com/news/sanofi-ablynx-announce-success-of-initial-tender-offer/ Mon, 14 May 2018 12:46:44 -0000 Partnership The US Food and Drug Administration (FDA) has accepted priority review of the biologics licence application (BLA) for cemiplimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC)... https://www.epmmagazine.com/news/fda-accepts-priority-review-of-bla-for-cemiplimab/ https://www.epmmagazine.com/news/fda-accepts-priority-review-of-bla-for-cemiplimab/ Mon, 30 Apr 2018 12:02:57 -0000 Priority review The marketing authorisation application (MAA) for cemiplimab as a potential treatment for advanced cutaneous squamous cell carcinoma (CSCC) has been accepted for review by the European Medicines Agency (EMA). https://www.epmmagazine.com/news/ema-accepts-maa-for-cemiplimab/ https://www.epmmagazine.com/news/ema-accepts-maa-for-cemiplimab/ Wed, 04 Apr 2018 12:42:21 -0000 Review The European Medicines Agency (EMA) has accepted for review an application for an add-on maintenance treatment in certain adults and adolescents (12 years and older) with inadequately controlled moderate-to-severe asthma, Dupixent (dupilumab). https://www.epmmagazine.com/news/dupixent-to-be-reviewed-as-a-potential-treatment-for-asthma/ https://www.epmmagazine.com/news/dupixent-to-be-reviewed-as-a-potential-treatment-for-asthma/ Tue, 03 Apr 2018 12:39:41 -0000 Asthma The European Medicines Agency (EMA) has accepted Sanofi’s regulatory submission for sotagliflozin, a potential treatment for type 1 diabetes, for review. https://www.epmmagazine.com/news/mea-accepts-marketing-authorisation-submission-for-sotagliflozin/ https://www.epmmagazine.com/news/mea-accepts-marketing-authorisation-submission-for-sotagliflozin/ Thu, 29 Mar 2018 12:27:36 -0000 Type I diabetes Plans have been announced by Sanofi and Regeneron to make Praluent (alirocumab) more accessible and affordable for those patients with the greatest health risk and unmet need. https://www.epmmagazine.com/news/praluent-to-be-made-more-accessible-and-affordable/ https://www.epmmagazine.com/news/praluent-to-be-made-more-accessible-and-affordable/ Mon, 12 Mar 2018 10:54:23 -0000 affordable drugs Sanofi has completed its acquisition of Bioverativ for $105 per share in cash. As a result, Bioverativ is now a fully owned subsidiary of Sanofi. https://www.epmmagazine.com/news/sanofi-completes-acquisition-of-bioverativ/ https://www.epmmagazine.com/news/sanofi-completes-acquisition-of-bioverativ/ Fri, 09 Mar 2018 11:27:00 -0000 Dollars The US Food and Drug Administration (FDA) has accepted the supplemental biologics licence application (sBLA) of Dupixent (dupilumab) for review, revealed joint developers of the drug, Regeneron and Sanofi. https://www.epmmagazine.com/news/fda-accepts-sBLA-for-dupixent/ https://www.epmmagazine.com/news/fda-accepts-sBLA-for-dupixent/ Fri, 02 Mar 2018 12:09:48 -0000 FDA approved Here we count down the top five tweets from @EPM_magazine that have gained the most impressions this week, taken from Twitter analytics. https://www.epmmagazine.com/news/the-top-five-tweets-from-alex-azar-to-generics/ https://www.epmmagazine.com/news/the-top-five-tweets-from-alex-azar-to-generics/ Fri, 02 Feb 2018 15:00:00 -0000 Top five Sanofi has requested a review by the European Medicines Agency (EMA) of its treatment for sleeping sickness, fexinidazole, which it is developing in collaboration with the Drugs for Neglected Disease initiative (DNDi). https://www.epmmagazine.com/news/ema-review-of-sleeping-sickness-treatment-requested-by-sanof/ https://www.epmmagazine.com/news/ema-review-of-sleeping-sickness-treatment-requested-by-sanof/ Wed, 31 Jan 2018 12:35:52 -0000 Sleeping sickness Sanofi is to acquire all outstanding ordinary shares of a biopharmaceutical company that is currently focused on the discovery and development of Nanobodies, Ablynx. https://www.epmmagazine.com/news/sanofi-to-acquire-biopharma-company-ablynx/ https://www.epmmagazine.com/news/sanofi-to-acquire-biopharma-company-ablynx/ Mon, 29 Jan 2018 12:34:54 -0000 Acquisition A definitive acquisition agreement has been formed between Sanofi and biopharmaceutical company, Bioverativ, which will see Sanofi acquire all the outstanding shares of Bioverativ for an equity value of approximately $11.6 billion. https://www.epmmagazine.com/news/sanofi-to-acquire-biopharma-company-for-11-6-billion/ https://www.epmmagazine.com/news/sanofi-to-acquire-biopharma-company-for-11-6-billion/ Mon, 22 Jan 2018 09:50:47 -0000 acquisition puzzle Sanofi and Regeneron have revealed that they will accelerate and expand investment for the clinical development programmes of cemiplimab in oncology and dupilumab in type 2 allergic diseases. https://www.epmmagazine.com/news/sanofi-regeneron-accelerate-and-expand-investment-for-cemipl/ https://www.epmmagazine.com/news/sanofi-regeneron-accelerate-and-expand-investment-for-cemipl/ Wed, 10 Jan 2018 12:13:06 -0000 Investment growth Two biotech companies, APEIRON and Evotec, have received the first milestone payment from Sanofi as part of the three-party immune-oncology alliance that was signed in 2015. https://www.epmmagazine.com/news/first-milestone-payment-achieved-in-immune-oncology-alliance/ https://www.epmmagazine.com/news/first-milestone-payment-achieved-in-immune-oncology-alliance/ Tue, 09 Jan 2018 10:46:12 -0000 Milestone payment Sanofi and RNAi therapeutics company, Alnylam Pharmaceuticals, have begun strategic restructuring of their RNAi therapeutics alliance to streamline and optimise development and commercialisation of certain products https://www.epmmagazine.com/news/sanofi-and-alnylam-are-restructuring-rnai-therapeutic-allian/ https://www.epmmagazine.com/news/sanofi-and-alnylam-are-restructuring-rnai-therapeutic-allian/ Mon, 08 Jan 2018 12:55:37 -0000 Restructuring With festivities and holidays galore during the latter part of December we thought it would be a good idea to briefly run through some of the pharma news that came out in the run up to Christmas. https://www.epmmagazine.com/news/pharma-news-round-up-what-might-have-been-missed-in-the-run-/ https://www.epmmagazine.com/news/pharma-news-round-up-what-might-have-been-missed-in-the-run-/ Tue, 02 Jan 2018 12:47:11 -0000 Newspapers round up Here we count down the top five tweets from @EPM_magazine that have gained the most impressions this week, taken from Twitter analytics. https://www.epmmagazine.com/news/the-top-five-tweets-from-brexit-to-huntingtons/ https://www.epmmagazine.com/news/the-top-five-tweets-from-brexit-to-huntingtons/ Fri, 15 Dec 2017 15:00:00 -0000 Top five The US Food and Drug Administration (FDA) has approved Sanofi’s short-acting insulin (Admelog — insulin lispro injection) as a ‘follow on’ product to treat diabetes. https://www.epmmagazine.com/news/fda-approves-sanofi%E2%80%99s-short-acting-insulin-as-%E2%80%98follow-on%E2%80%99-tr/ https://www.epmmagazine.com/news/fda-approves-sanofi%E2%80%99s-short-acting-insulin-as-%E2%80%98follow-on%E2%80%99-tr/ Tue, 12 Dec 2017 12:19:30 -0000 Diabetes Sanofi is requesting that health authorities update information on its dengue vaccine Dengvaxia, as a result of a new analysis of long-term clinical trial data, which found differences in vaccine performance based on prior dengue infection. https://www.epmmagazine.com/news/sanofi-requests-health-authorities-update-information-on-den/ https://www.epmmagazine.com/news/sanofi-requests-health-authorities-update-information-on-den/ Thu, 30 Nov 2017 14:53:51 -0000 Update Lead Pharma has achieved a third milestone under its research collaboration with Sanofi, which has triggered an undisclosed milestone payment. https://www.epmmagazine.com/news/lead-pharma-achieves-third-milestone-under-research-collabor/ https://www.epmmagazine.com/news/lead-pharma-achieves-third-milestone-under-research-collabor/ Wed, 22 Nov 2017 12:34:20 -0000 Milestone Sanofi and Principia Biopharma have entered into an agreement to develop a clinical-stage oral drug candidate as a potential therapy for multiple sclerosis (MS) and other central nervous system (CNS) diseases. https://www.epmmagazine.com/news/sanofi-and-principia-join-forces-to-advance-potential-ms-the/ https://www.epmmagazine.com/news/sanofi-and-principia-join-forces-to-advance-potential-ms-the/ Fri, 10 Nov 2017 09:00:00 -0000 Brain cancer vaccine awarded orphan status by FDA Sanofi and Regeneron Pharmaceuticals have revealed positive results from a Phase II investigational study of dupilumab, for the treatment of adults with moderate-to-severe eosinophilic oesophagitis. https://www.epmmagazine.com/news/dupilumab-improves-ability-to-swallow-according-to-study-res/ https://www.epmmagazine.com/news/dupilumab-improves-ability-to-swallow-according-to-study-res/ Tue, 17 Oct 2017 12:28:30 -0000 Oesophagus Global healthcare company Sanofi has announced it is investing €170 million to expand its vaccine manufacturing site in Val de Reuil, France. https://www.epmmagazine.com/news/sanofi-invests-in-french-vaccine-production-facility/ https://www.epmmagazine.com/news/sanofi-invests-in-french-vaccine-production-facility/ Thu, 12 Oct 2017 12:46:03 -0000 French flag The European Commission (EC) has granted marketing authorisation to Sanofi and Regeneron Pharmaceuticals for dupilumab (Dupixent) for the treatment of adults with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy. https://www.epmmagazine.com/news/targeted-biologic-receives-eu-approval-for-treatment-of-atop/ https://www.epmmagazine.com/news/targeted-biologic-receives-eu-approval-for-treatment-of-atop/ Thu, 28 Sep 2017 12:00:12 -0000 Regulatory approval Sanofi and Regeneron Pharmaceuticals have revealed that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation status to cemiplimab (REGN2810), an investigational human, monoclonal antibody. https://www.epmmagazine.com/news/cemiplimab-receives-breakthrough-therapy-designation/ https://www.epmmagazine.com/news/cemiplimab-receives-breakthrough-therapy-designation/ Mon, 11 Sep 2017 14:30:55 -0000 Breakthrough medicine A research collaboration between Axxam and Sanofi has been announced, which will be aimed at further optimising several small molecules targeted against a range of diseases of the central nervous system (CNS). https://www.epmmagazine.com/news/axxam-sanofi-enter-into-research-collaboration/ https://www.epmmagazine.com/news/axxam-sanofi-enter-into-research-collaboration/ Tue, 05 Sep 2017 12:00:51 -0000 Collaboration Here we count down the top five tweets from @EPM_magazine that have gained the most impressions this week, taken from Twitter analytics. https://www.epmmagazine.com/news/the-top-five-tweets-from-car-t-to-biotech-%E2%80%94-what-did-epm-rea/ https://www.epmmagazine.com/news/the-top-five-tweets-from-car-t-to-biotech-%E2%80%94-what-did-epm-rea/ Fri, 01 Sep 2017 13:58:14 -0000 Top five Sanofi has announced the completion of its acquisition of a privately-held US vaccines biotech company, Protein Sciences, following Federal Trade Commission approval. https://www.epmmagazine.com/news/sanofi-completes-acquisition-of-vaccines-biotech-company/ https://www.epmmagazine.com/news/sanofi-completes-acquisition-of-vaccines-biotech-company/ Tue, 29 Aug 2017 15:37:00 -0000 Acquisition Sanofi and Regeneron Pharmaceuticals have announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion for marketing authorization of Dupixent (dupilumab). https://www.epmmagazine.com/news/treatment-for-atopic-dermatitis-receives-positive-chmp-opini/ https://www.epmmagazine.com/news/treatment-for-atopic-dermatitis-receives-positive-chmp-opini/ Mon, 24 Jul 2017 10:00:00 -0000 Regulatory approval Biopharmaceutical company, Ablynx, and Sanofi have entered into a strategic collaboration for the development of Nanobody based therapeutics for the treatment of immune-mediated inflammatory diseases. https://www.epmmagazine.com/news/strategic-collaboration-announced-to-develop-nanobody-therap/ https://www.epmmagazine.com/news/strategic-collaboration-announced-to-develop-nanobody-therap/ Thu, 20 Jul 2017 12:22:06 -0000 Collaboration Felicity Thomas Here we count down the top five tweets from @EPM_magazine that have gained the most impressions this week, taken from Twitter analytics. https://www.epmmagazine.com/news/the-top-five-tweets-from-fda-approvals-to-a-serialisation-%E2%80%94-/ https://www.epmmagazine.com/news/the-top-five-tweets-from-fda-approvals-to-a-serialisation-%E2%80%94-/ Fri, 14 Jul 2017 15:51:20 -0000 Top five Sanofi has revealed it will acquire Protein Sciences, a privately held vaccines biotechnology company based in Meriden, Connecticut, which will add the only recombinant-based flu vaccine approved by the US Food and Drug Administration (FDA) to its po https://www.epmmagazine.com/news/sanofi-adds-recombinant-based-flu-vaccine-to-portfolio-throu/ https://www.epmmagazine.com/news/sanofi-adds-recombinant-based-flu-vaccine-to-portfolio-throu/ Tue, 11 Jul 2017 12:19:20 -0000 Flu virus Sanofi and Regeneron Pharmaceuticals have announced that the European Commission (EC) has granted marketing authorisation of Kevzara in combination with methotrexate for the treatment of moderately to severely active rheumatoid arthritis in adults https://www.epmmagazine.com/news/kevzara-approved-for-treatment-of-rheumatoid-arthritis-in-th/ https://www.epmmagazine.com/news/kevzara-approved-for-treatment-of-rheumatoid-arthritis-in-th/ Tue, 27 Jun 2017 11:45:53 -0000 Rheumatoid arthritis Felicity Thomas Global biopharmaceutical services organisation, Parexel, and global life sciences company, Sanofi, are collaborating on a pilot study to advance the use of wearable devices in the collection of data and management of clinical trials. https://www.epmmagazine.com/news/collaborative-pilot-study-set-to-validate-the-use-of-wearabl/ https://www.epmmagazine.com/news/collaborative-pilot-study-set-to-validate-the-use-of-wearabl/ Mon, 19 Jun 2017 12:04:33 -0000 Smart clinical trials Felicity Thomas Sanofi and Regeneron Pharmaceuticals have announced positive results from two Phase IIIb/IV ODYSSEY-DM trials evaluating Praluent (alirocumab) in patients with diabetes and hypercholesterolemia. https://www.epmmagazine.com/news/positive-results-from-trials-evaluating-praluent-announced/ https://www.epmmagazine.com/news/positive-results-from-trials-evaluating-praluent-announced/ Mon, 12 Jun 2017 10:39:18 -0000 Results Jean-Marc Bobée Jean-Marc Bobée, former director, industrial anti-counterfeiting strategy at Sanofi, outlines global and local traceability concepts and their individual ‘security to cost’ ratios, highlighting the need for a standardised global serialisation https://www.epmmagazine.com/opinion/serialisation-concepts-why-a-global-strategy-should-be-the-u/ https://www.epmmagazine.com/opinion/serialisation-concepts-why-a-global-strategy-should-be-the-u/ Fri, 26 May 2017 15:44:16 -0000 Global strategy Felicity Thomas Sanofi and Regeneron Pharmaceuticals have announced the FDA’s approval of Kevzara (sarilumab) for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) https://www.epmmagazine.com/news/kevzara-is-now-available-to-us-patients-thanks-to-fda-approv/ https://www.epmmagazine.com/news/kevzara-is-now-available-to-us-patients-thanks-to-fda-approv/ Thu, 25 May 2017 11:44:34 -0000 FDA approval Felicity Thomas Sanofi and Regeneron Pharmaceuticals has announced that the FDA has accepted the resubmission of the biologics licence application for Kevzara (sarilumab) as a Class I response with a two-month review timeline. https://www.epmmagazine.com/news/kevzara-biologics-licence-application-resubmission-accepted/ https://www.epmmagazine.com/news/kevzara-biologics-licence-application-resubmission-accepted/ Fri, 28 Apr 2017 13:35:41 -0000 Accepted tick Felicity Thomas Sanofi and Regeneron have received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for the marketing authorisation of Kevzara (sarilumab). https://www.epmmagazine.com/news/chmp-recommends-use-of-kevzara-to-treat-ra/ https://www.epmmagazine.com/news/chmp-recommends-use-of-kevzara-to-treat-ra/ Tue, 25 Apr 2017 11:50:29 -0000 Rheumatoid arthritis Felicity Thomas Bill Sibold has been appointed as executive vice president of Sanofi Genzyme with effect from 1 July. In this role, he will also be a member of the executive committee. https://www.epmmagazine.com/news/sanofi-appoints-bill-sibold-as-executive-vp/ https://www.epmmagazine.com/news/sanofi-appoints-bill-sibold-as-executive-vp/ Thu, 06 Apr 2017 10:48:47 -0000 Hired Felicity Thomas Sanofi and Regeneron Pharmaceuticals have announced that the US FDA has approved Dupixent (dupilumab) injection, which is the first targeted biologic therapy for adults suffering from moderate-to-severe atopic dermatitis. https://www.epmmagazine.com/news/fda-approve-dupixent-for-moderate-to-severe-ad/ https://www.epmmagazine.com/news/fda-approve-dupixent-for-moderate-to-severe-ad/ Wed, 29 Mar 2017 12:08:35 -0000 AD treatment Sanofi and Sanofi Pasteur have announced an agreement with MedImmune to develop and commercialise a monoclonal antibody for the prevention of Respiratory Syncytial Virus (RSV). https://www.epmmagazine.com/news/sanofi-announce-agreement/ https://www.epmmagazine.com/news/sanofi-announce-agreement/ Fri, 03 Mar 2017 11:10:00 -0000 RSV Pharmaceutical company Sanofi and supplier to the pharma/biotech Lonza have announced a partnership to build and operate a large-scale mammalian cell culture facility for monoclonal antibody production in Visp, Switzerland. https://www.epmmagazine.com/news/sanofi-and-lonza-announce-partnership-to-develop/ https://www.epmmagazine.com/news/sanofi-and-lonza-announce-partnership-to-develop/ Mon, 27 Feb 2017 10:30:00 -0000 New House