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Sanofi’s Sarclisa Wins New Japan Approval for Multiple Myeloma Combination Therapy
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Sanofi (EPA: SAN, NASDAQ: SNY) announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved a new indication for Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for adult patients with newly diagnosed multiple myeloma (NDMM). This marks the fourth treatment regimen approved for Sarclisa in…
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CDE Includes Chiral Tech’s Cerdelga Generic in Rare Disease Care Plan
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China’s Center for Drug Evaluation (CDE) announced the inclusion of Beijing Chiral Tech’s generic version of Sanofi Genzyme’s Cerdelga (eliglustat) in the patient-centered rare disease drug development pilot program, known as the Care Plan. The move aims to accelerate access to affordable treatments for rare diseases. Drug ProfileEliglustat, a glucosylceramide…
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Sanofi and Teva’s Duvakitug Hits Key Milestones in UC and CD Study at ECCO Congress
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Sanofi (EPA: SAN, NASDAQ: SNY) and Teva Pharmaceutical Industries Ltd (NYSE: TEVA) presented Phase IIb data for duvakitug, their experimental monoclonal antibody targeting TL1A, at the 20th European Crohn’s and Colitis Organisation (ECCO) Congress. The RELIEVE UCCD study evaluated the drug in moderate-to-severe ulcerative colitis (UC) and Crohn’s disease (CD),…
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Sanofi’s Dupixent Receives Priority Review from FDA for Bullous Pemphigoid Treatment
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Sanofi (EPA: SAN, NASDAQ: SNY) announced that the US Food and Drug Administration (FDA) has accepted the supplemental biologics license application (sBLA) for Dupixent (dupilumab) for the treatment of adults with bullous pemphigoid (BP) and granted it priority review status. The FDA is expected to make its decision by June…
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Sanofi’s Merilog Biosimilar Wins FDA Approval for Diabetes Treatment
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The U.S. Food and Drug Administration (FDA) has approved Sanofi-Aventis’ (EPA: SAN) Merilog, a biosimilar of Novo Nordisk’s (NYSE: NVO) NovoLog. Merilog, a rapid-acting insulin, is indicated for the improvement of glycemic control in adults and pediatric patients with diabetes mellitus. The approval includes both a 3 milliliter (mL) single-patient-use…
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Sanofi and J&J’s E. coli Vaccine Fails Phase III Study
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France-based Sanofi (NASDAQ: SNY) and US giant Johnson & Johnson’s (J&J, NYSE: JNJ) vaccine candidate for extraintestinal pathogenic E. coli failed to meet expectations in a Phase III study. An independent data monitoring committee (IDMC) determined that the vaccine was insufficiently effective at preventing invasive E. coli disease (IED) compared…
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Sanofi Reports Strong Q4 Growth, Plans EUR 5 Billion Share Buyback
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French pharmaceutical giant Sanofi (NASDAQ: SNY) reported a strong fourth-quarter performance with 10.3% year-on-year (YOY) growth in net sales in constant currency terms, reaching EUR 10.564 billion ($11 billion). The growth was driven by a 56.5% increase in new pharma launches, a 16% rise in sales of Dupixent (dupilumab), and…
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Sanofi’s Sarclisa Approved in EU for Newly Diagnosed Multiple Myeloma
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France-based Sanofi (EPA: SAN, NASDAQ: SNY) has announced receiving marketing approval in the European Union (EU) for its CD38 monoclonal antibody (mAb) Sarclisa (isatuximab) in combination with the standard-of-care regimen of bortezomib, lenalidomide, and dexamethasone (VRd). The approval is for the treatment of adult patients with newly diagnosed multiple myeloma…
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FDA Lifts Clinical Hold on Sanofi’s Cialis Over-the-Counter Trial
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France-based Sanofi’s (NASDAQ: SNY, EPA: SAN) Consumer Healthcare unit Opella has announced that the US FDA has lifted a clinical hold on its planned Actual Use Trial (AUT) for Cialis (tadalafil). This move allows Sanofi to initiate the AUT and potentially switch the PDE5 inhibitor from a prescription to an…
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Sanofi’s Sarclisa Meets Co-Primary Endpoints in Phase III IRAKLIA Study for Multiple Myeloma
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French pharmaceutical giant Sanofi (NASDAQ: SNY, EPA: SAN) has announced that the Phase III IRAKLIA study for its Sarclisa (isatuximab) met its co-primary endpoints when administered subcutaneously (SC) via an on-body delivery system (OBDS) in patients with multiple myeloma (MM). This marks a significant step forward in the treatment of…
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Alloy Therapeutics and Sanofi Collaborate on CNS Drug Development with AntiClastic Antisense Platform
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US-based Alloy Therapeutics Inc. has announced a target-specific collaboration and license agreement with Sanofi (NASDAQ: SNY), the French pharmaceutical giant. The partnership aims to leverage Alloy’s neuroscience expertise to develop a novel drug targeting the central nervous system (CNS) based on Alloy’s proprietary AntiClastic Antisense Platform. This technology, launched by…
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Sanofi’s Sarclisa Gains NMPA Approval for Multiple Myeloma Treatment in China
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French pharmaceutical giant Sanofi (NASDAQ: SNY) has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its Sarclisa (isatuximab) in combination with pomalidomide plus dexamethasone. This approval is for the treatment of adult patients with multiple myeloma who have previously received at least first-line…
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Sanofi and SK bioscience Broaden Partnership to Develop Next-Gen Pneumococcal Vaccines
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French pharmaceutical major Sanofi (NASDAQ: SNY) and South Korea-based SK bioscience (KRX: 302440) have announced an expansion of their partnership to develop, license, and commercialize next-generation pneumococcal conjugate vaccines (PCVs) targeting both pediatric and adult populations. Milestone in Pediatric Vaccine DevelopmentTheir existing agreement, which aimed to develop and commercialize a…
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Hainan Boao Lecheng and Sanofi Partner with Paris-Saclay Cancer Cluster for Advanced Cancer Treatments
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The Hainan Boao Lecheng International Medical Tourism Pilot Zone, in collaboration with France’s major Sanofi’s (NASDAQ: SNY) China unit and the Paris-Saclay Cancer Cluster (PSCC), has established a tripartite collaboration aimed at advancing healthcare solutions. This partnership is designed to combine the strengths of each organization to enhance the treatment…
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Sanofi and Corxel Pharmaceuticals Partner for Aficamten in Greater China Rights
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Global healthcare leader Sanofi (NASDAQ: SNY) and China-based Corxel Pharmaceuticals (CORXEL), formerly known as Ji Xing Pharmaceuticals, have jointly announced an official agreement. Under this partnership, Sanofi is set to acquire exclusive development and commercialization rights to CORXEL’s aficamten in Greater China. The financial details of the deal have not…
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Sanofi’s Tolebrutinib Earns FDA Breakthrough Designation for Non-Relapsing Secondary Progressive MS
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Sanofi (NASDAQ: SNY) has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to its Bruton’s tyrosine kinase (BTK) inhibitor, Tolebrutinib, for the treatment of adults with non-relapsing secondary progressive multiple sclerosis (nrSPMS). Phase III HERCULES Study Results Influence FDA DecisionThe FDA’s decision is supported…
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Sanofi Receives FDA Fast-Track Designation for Influenza and COVID-19 Combo Vaccine Candidates
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Sanofi (NASDAQ: SNY) has announced that it has received Fast-Track Designations from the US Food and Drug Administration (FDA) for its combination vaccine candidates aimed at preventing influenza and COVID-19 infections in individuals aged 50 and older. Details of the Combination Vaccine CandidatesOne of the combination vaccine candidates (NCT06695117) pairs…
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Sanofi Announces EUR 1 Billion Investment for New Beijing Manufacturing Plant
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French pharmaceutical company Sanofi (NASDAQ: SNY) has announced plans to invest EUR 1 billion (USD 1.05 billion) in the construction of a new manufacturing plant in the Beijing Economic-Technological Development Area. This marks the company’s largest investment in China to date. Expanding Local Manufacturing Capacities for InsulinThe new facility will…
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Sanofi Launches Modulus, a Pioneering Manufacturing Facility in Singapore
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Global healthcare company Sanofi (NASDAQ: SNY) has inaugurated Modulus, its state-of-the-art manufacturing facility in Singapore. This facility, which employs an ‘industry first’ modular concept, is designed to offer flexible manufacturing capabilities for the production of next-generation vaccines and biological medicines. Investment and Capabilities of ModulusThe SGD 800 million (USD 558…
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Jiangsu Hengrui Medicine’s SHR-1819 Receives NMPA Approval for Atopic Dermatitis Clinical Trial
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its novel monoclonal antibody, SHR-1819. This injectable treatment can now proceed to Phase Ib/II studies, focusing on atopic dermatitis (AD) in children and adolescents aged 6-17…
