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French pharmaceutical giant Sanofi has announced that the US Food and Drug Administration (FDA) has accepted for review the supplemental biologics license application (sBLA) for Dupixent (dupilumab). The application seeks to expand the monoclonal antibody’s (mAb) indication to treat adults and pediatric patients aged 12 years and older with chronic…
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French pharmaceutical giant Sanofi (NASDAQ: SNY) has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the treatment of adult patients with…
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Canada-based diabetes life sciences company, Zucara Therapeutics Inc., has announced the receipt of a strategic investment totaling USD 20 million from global pharmaceutical leader Sanofi (NASDAQ: SNY) and Perceptive Xontogeny Venture Fund (PXV Fund I). This investment is a significant component of Zucara’s USD 20 million Series B financing round,…
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French pharmaceutical giant Sanofi (NASDAQ: SNY) has signed a partnership deal with Cathay Capital, a global private equity and venture capital investment firm, at the 7th China International Import Expo (CIIE). This collaboration aims to deepen their existing long-term cooperation and serves as a positive step towards promoting Sino-French cooperation…
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At the 7th China International Import Expo (CIIE), China-based Shanghai Pharmaceutical Co., Ltd (SPH, SHA: 601607, HKG: 2607) announced a series of partnerships with prominent pharmaceutical companies, spanning domestic and international entities. Expanding Collaborations in Pharmaceutical InnovationFrance’s Sanofi (NASDAQ: SNY) has agreed to deepen its existing partnership with SPH, initially…
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French pharmaceutical giant Sanofi (NASDAQ: SNY) has announced that it has received marketing approval from the European Medicines Agency (EMA) for its drug Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE) in children aged one to 11 years who weigh at least 15 kg. The approval covers patients who are inadequately…
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The National Medical Products Administration (NMPA) has released the 84th batch of reference drugs for generic quality consistency evaluation (GQCE) work, marking a significant step in the regulation of generic drug quality in China. Concurrently, the NMPA has also announced the first batch of reference drugs that have been stripped…
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Sanofi (NASDAQ: SNY), the French pharmaceutical giant, has announced the presentation of new data from the Phase III LIBERTY-CUPID Study C for its drug Dupixent (dupilumab) in the treatment of chronic spontaneous urticaria (CSU) at the American College of Allergy, Asthma and Immunology (ACAAI) 2024 annual meeting. The LIBERTY-CUPID Study…
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Sanofi (EPA: SAN), a leading French pharmaceutical company, has entered into a strategic agreement with Orano Med, a subsidiary of the French Orano Group, to enhance the development of next-generation radioligand medicines. The collaboration aims to accelerate the growth of radioligand therapies (RLTs) based on lead-212 (212Pb) alpha-emitting isotopes, which…
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Thermo Fisher Scientific’s (NYSE: TMO) Greenville, North Carolina, facility has come under scrutiny after a US Food and Drug Administration (FDA) inspection revealed certain production procedure issues, including the monitoring and measurement of air bubbles within syringes, according to a Form 483 document obtained by Reuters. The inspection was part…
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Regeneron (NASDAQ: REGN), a leading biopharmaceutical company based in the U.S., in collaboration with its French partner Sanofi (NSE: SANOFI), announced on September 27 that Dupixent (dupilumab) has received approvals for the treatment of chronic obstructive pulmonary disorder (COPD) from both the U.S. Food and Drug Administration (FDA) and China’s…
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TJ Biopharma, a biopharmaceutical company based in China, has entered into a licensing agreement with the French pharmaceutical giant Sanofi. This agreement grants Sanofi exclusive rights to develop, manufacture, and commercialize TJ Biopharma’s anti-CD73 antibody, uliledlimab (TJD5), in Greater China. As part of the deal, Sanofi will make an upfront…
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French pharmaceutical giant Sanofi S.A. (EPA: SAN; NASDAQ: SNY) has reportedly received multiple binding offers for its consumer health care (CHC) division, from private equity firms Clayton Dubilier & Rice and PAI Partners, according to sources cited by Bloomberg. The potential deal could value the business at up to EUR…
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Sanofi (EPA: SAN; NASDAQ: SNY) has announced that the US Food and Drug Administration (FDA) has granted a third indication for its CD38 antibody Sarclisa (isatuximab) for the treatment of multiple myeloma (MM). The new approval allows for the first-line use of Sarclisa in combination with standard-of-care treatments, specifically bortezomib,…
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Sanofi (EPA: SAN; NASDAQ: SNY), a leading French pharmaceutical company, has entered into a significant licensing agreement with US biotechnology firm RadioMedix Inc. and French company Orano Med, securing global rights to a radioligand therapy (RLT). The agreement centers on AlphaMexi (212Pb-DOTAMTATE), a targeted alpha therapy (TAT) that utilizes a…
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Sanofi (EPA: SAN; NASDAQ: SNY), a leading French pharmaceutical company, has announced positive results from two Phase III clinical trials for its drug Dupixent (dupilumab), indicating its potential for two distinct indications. The first trial, ADEPT, concentrated on the treatment of the rare skin condition bullous pemphigoid (BP), while the…
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Euroapi (EPA: EAPI), a French company and a spinoff from Sanofi established in 2022, has announced plans to reduce production of 13 active pharmaceutical ingredients (APIs), as reported by Nikkei News. This strategic decision will lead to the divestment of its manufacturing facilities located in Brindisi, Italy, and Haverhill, UK,…
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PARIS—French pharmaceutical giant Sanofi (Nasdaq: SNY; EURONEXT: SAN) has reported mixed outcomes from three Phase III trials for its Bruton’s tyrosine kinase (BTK) inhibitor, tolebrutinib, as a treatment for multiple sclerosis (MS). The drug candidate achieved success in the HERCULES study, where it met the primary endpoint of delaying the…
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Sanofi (NASDAQ: SNY), the French pharmaceutical giant, has reportedly suspended the distribution and sale of its flu vaccines in China following concerns over declining potency identified during routine batch checks. According to FiercePharma.com, which cites an email from a Sanofi spokesperson, the suspension will affect supplies of both Vaxigrip and…
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Sanofi (NASDAQ: SNY; EPA: SAN), the French multinational pharmaceutical company, has reported its financial results for the second quarter of 2024, demonstrating a robust year-on-year growth of 10.2% in global net sales, reaching €10.745 billion (USD 11.64 billion) in constant currency terms. This growth was driven by the company’s Pharma…
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Sanofi (NASDAQ: SNY; EPA: SAN), a leading French multinational pharmaceutical company, has announced plans to significantly expand its global capacity center (GCC) in Hyderabad, India. The company intends to invest EUR 400 million, equivalent to approximately USD 437 million, over a six-year period. This expansion will create an additional 1,600…
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Sanofi (NASDAQ: SNY), a leading French pharmaceutical company, has announced the commercial launch of Beyfortus (nirsevimab), a preventative therapy for Respiratory Syncytial Virus (RSV), in China. Nirsevimab, a long-acting monoclonal antibody (mAb), is the first and only RSV preventative therapy in China that covers a wide range of infants, including…
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Tzield (teplizumab), recognized as the world’s first and only targeted therapy for delaying the onset of type 1 diabetes, has received approval for use in the Boao Lecheng medical tourism pilot zone as a clinically urgently needed import drug. Developed by French pharmaceutical giant Sanofi, Tzield is indicated for use…
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Sanofi (NYSE: SNY) is reportedly inviting bids starting at USD 20 billion for its consumer healthcare division, according to a Bloomberg report citing people familiar with the matter. The French pharmaceutical giant is anticipating initial bids by mid-July. Among the parties showing the most interest are Advent International, a U.S.…
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Sanofi (NASDAQ: SNY; EPA: SAN), a major French pharmaceutical company, has formed a collaboration with U.S.-based Belharra Therapeutics, a chemoproteomics company focused on the development of small-molecule cancer drugs targeting high-value, elusive drug targets. As per the agreement, Belharra will utilize its non-covalent chemoproteomics platform to screen for hits against…
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Sanofi (EPA: SAN), a major French multinational pharmaceutical company, has announced that it has received clinical trial approval from China’s National Medical Products Administration (NMPA) for SP0125, a nasal spray respiratory syncytial virus (RSV) attenuated live vaccine intended for use in infants and young children. RSV is among the most…
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Sanofi (NASDAQ: SNY), a leading French pharmaceutical company, is enhancing its supply chain strategy with artificial intelligence-based technologies provided by Bluecrux, a consulting and technology firm based in Belgium. Bluecrux’s solution consolidates all of Sanofi’s data systems into a unified model, enabling comprehensive end-to-end visibility across the company’s supply chain.…
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Sanofi plc (NYSE: SNY), a leading pharmaceutical company based in France, has announced that the U.S. Food and Drug Administration (FDA) has granted priority review status to a supplemental approval filing for its drug Sarclisa (isatuximab). The priority status is in recognition of the molecule’s potential use in treating adult…
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Sanofi (NASDAQ: SNY), the France-based multinational pharmaceutical company, has announced a cutting-edge collaboration with US firms Formation Bio and OpenAI to develop customized artificial intelligence (AI) models designed to expedite drug development. While the financial specifics of the agreement were not disclosed, the partnership signifies Sanofi’s strategic commitment to leveraging…
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France’s Sanofi (NASDAQ: SNY) has announced a strategic partnership with protein-based vaccines specialist Novavax (NASDAQ: NVAX), aiming to enhance its immunization portfolio. Under the agreement, Sanofi will gain access to Novavax’s Matrix-M adjuvant and secure exclusive rights to combine its influenza vaccines with Novavax’s SARS-CoV-2 vaccine. Sanofi will also co-commercialize…
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AbbVie (NYSE: ABBV) has announced positive results from a head-to-head Phase IIIb/IV clinical trial comparing its JAK inhibitor Rinvoq (upadacitinib) with Sanofi’s (NASDAQ: SNY) interleukin blocker Dupixent (dupilumab) in patients with moderate-to-severe atopic dermatitis. The trial demonstrated that Rinvoq was superior in improving eczema area and severity as well as…
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France-based pharmaceutical giant Sanofi (NASDAQ: SNY) has reported its financial results for the first quarter of 2024, with sales increasing by 6.7% year-on-year (YOY) in constant exchange rate terms to €10.46 billion (USD 11.23 billion). The biopharma segment experienced growth of 6.3%, with pharmaceutical sales rising by 6.4% to €7.76…
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French pharmaceutical company Sanofi (NASDAQ: SNY) has announced that its Phase III trial for rilzabrutinib, a potential best-in-class BTK inhibitor, has successfully met its primary endpoint of durable platelet response in patients with immune thrombocytopenia (ITP). The trial also produced positive results in key secondary endpoints and did not raise…
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Sanofi (NASDAQ: SNY), a French multinational pharmaceutical company, has administered the first dose to a patient in the second part of a Phase I/II clinical trial for the trifunctional NK cell engager SAR443579, targeting blood cancers. The announcement was made by fellow French biotechnology company Innate Pharma (NASDAQ: IPHA) this…
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Sanofi (NASDAQ: SNY), the France-based pharmaceutical giant, is reportedly in talks with potential buyers for Amunix Pharmaceuticals, an immuno-oncology company it acquired in 2021, according to Endpoints News. This move aligns with Sanofi’s 2023 earnings report, which outlined plans to shift resources away from oncology to bolster its immunology pipeline,…
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France’s Sanofi (NASDAQ: SNY) has announced an extension of its 2019 collaboration with Nurix Therapeutics (NASDAQ: NRIX), a leader in targeted protein degradation, focusing on the drug target STAT6 for type 2 inflammation. The partners anticipate identifying a clinical candidate within the next year. As part of the collaboration, Nurix…
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Swiss pharmaceutical giant Novartis (NYSE: NVS) is gearing up for a strategic restructuring that will result in the layoff of up to 680 staff members across its Swiss and US development teams. This move, reported by Endpoints News, comes on the heels of similar announcements from industry peers Bayer (ETR:…
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Paris-based pharmaceutical giant Sanofi (NASDAQ: SNY) is embarking on a comprehensive “full pipeline reprioritization” that will result in significant layoffs and corporate restructuring, according to an internal communication dated April 4, 2024. The strategic shift, led by Sanofi’s R&D head Dr. Houman Ashrafian, follows an extensive review and consultation with…
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Olivier Charmeil, Executive Vice-President for General Medicines at France-based Sanofi S.A. (NASDAQ: SNY), visited China this week to launch KiDS (Kids & Diabetes in Schools), a program aimed at enhancing health literacy in school environments. Charmeil, who previously served as Sanofi’s China region head, also spoke to local media platform…
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Sanofi (NASDAQ: SNY), a leading French pharmaceutical company, has released its guidance for the first quarter of 2024. Despite expectations that its top-selling interleukin blocker Dupixent (dupilumab) will face challenges from a co-pay assistance program in the first quarter, the company projects that the drug’s sales will reach EUR 13…
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Sanofi (NASDAQ: SNY), a French multinational pharmaceutical company, announced last week that the US Food and Drug Administration (FDA) has accepted for priority review an indication extension filing for its interleukin blocker Dupixent (dupilumab). The drug is proposed as an add-on maintenance treatment for uncontrolled chronic obstructive pulmonary disease (COPD),…
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Denali Therapeutics (NASDAQ: DNLI) has announced disappointing results from a Phase II trial of its RIPK1-targeted small-molecule drug for amyotrophic lateral sclerosis (ALS). The drug, developed in partnership with France-based Sanofi Inc. (NASDAQ: SNY), failed to meet the primary endpoint in the Phase II HIMALAYA study, which assessed the change…
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Sanofi (NASDAQ: SNY), a leading French pharmaceutical company, has released its financial report for the fourth quarter and full year of 2023. The company’s global revenues for the 12-month period reached EUR 43.07 billion (USD 47 billion), marking a 5.3% increase year-on-year in constant currency terms. Key drivers of this…
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Sanofi (NASDAQ: SNY), a leading French pharmaceutical company, has made an undisclosed investment in biotechnology firm Graviton Bioscience, securing a right of first negotiation for Graviton’s clinical-stage ROCK2 inhibitor candidates in immunological and metabolic syndrome indications. Graviton’s lead program, GV101, is a potential best-in-class ROCK2 inhibitor capable of crossing the…
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The US Food and Drug Administration (FDA) has concluded a priority review and granted approval to Sanofi (NASDAQ: SNY) and Regeneron (NASDAQ: REGN) for their interleukin blocker Dupixent (dupilumab) as a treatment for eosinophilic esophagitis (EoE) in patients aged 1 to 11 years. This indication expansion makes Dupixent the sole…
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French pharmaceutical giant Sanofi (NASDAQ: SNY) has announced the acquisition of INBRX-101, a promising candidate for rare genetic diseases, from U.S. biotechnology firm Inhibrx (NASDAQ: INBX). INBRX-101, currently in Phase II trials for alpha-1 antitrypsin deficiency (AATD), is a recombinant human AAT-Fc fusion protein designed to restore serum AAT activity,…
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Sanofi (NASDAQ: SNY) has been granted authorization by the US Food and Drug Administration (FDA) to update the label of Dupixent (dupilumab) to include efficacy and safety data for patients aged 12 and older with atopic dermatitis that involves uncontrolled moderate-to-severe hand or foot symptoms. The data from a late-stage…
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Paul Hudson, CEO of Sanofi (NASDAQ: SNY), stated this week that the France-based pharmaceutical company has no plans to develop a competing product in the GLP-1 drug market, dominated by Novo Nordisk (CPH: NOVO-B) and Eli Lilly (NYSE: LLY), despite significant demand. However, Houman Ashrafian, head of R&D, indicated that…
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AstraZeneca (AZ, NASDAQ: AZN) and Sanofi (NASDAQ: SNY), co-development partners in the pharmaceutical industry, have announced that they have received marketing approval from the National Medical Products Administration (NMPA) for their drug Beyfortus (nirsevimab). The antibody is now approved for use in preventing lower respiratory tract infections caused by respiratory…
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Shanghai Pharmaceuticals (SPH; HKG: 2607; SHA: 601607) , a leading pharmaceutical company based in China, has entered into a comprehensive partnership with the French pharmaceutical giant Sanofi (NASDAQ: SNY). The collaboration aims to address major disease areas on a nationwide scale, establishing an end-to-end value chain system that spans from…
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Sanofi (NASDAQ: SNY), the French pharmaceutical giant, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its fixed-dose combination tablets of rosuvastatin and ezetimibe. This therapy is indicated for the treatment of hypercholesterolemia and homozygous familial hypercholesterolemia (HoFH). This product marks the first…
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Sanofi (NASDAQ: SNY) has announced the discontinuation of its antibody-drug conjugate (ADC) tusamitamab ravtansine following disappointing results from a Phase III trial in metastatic non-squamous (NSq) non-small cell lung cancer (NSCLC) patients with high CEACAM5 expression. The trial did not meet its dual primary endpoints, as indicated by an interim…
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French pharmaceutical giant Sanofi (NASDAQ: SNY) has expanded its partnership with UK-based AI-driven precision drug design company Exscientia (NASDAQ: EXAI) by in-licensing a program in an undisclosed therapeutic area. This move builds on a 2022 agreement aimed at developing up to 15 novel small-molecule candidates across oncology and immunology. The…
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Sanofi (NASDAQ: SNY) has in-licensed a natural killer (NK) cell engager candidate for solid tumors from France-based Innate Pharma (NASDAQ: IPHA), as per an agreement reached in 2022. Sanofi will pay an initial fee of EUR 15 million (USD 16.4 million) and is committed to potential milestone payments of up…
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Last week, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion on Sanofi’s (NASDAQ: SNY) Fexinidazole Winthrop (fexinidazole) as a 10-day treatment for acute sleeping sickness caused by Trypanosoma brucei (T.b.) rhodesiense in both adults and children. The EMA is…
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French pharmaceutical giant Sanofi (NASDAQ: SNY) has announced that its drug Rezurock (belumosudil), the world’s first and only ROCK2 inhibitor for the treatment of chronic graft-versus-host disease (cGVHD), has received marketing approval in China. Clinical data indicates that Rezurock achieves a 75% overall response rate (ORR), a 75% 6-month failure-free…
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Sanofi (NASDAQ: SNY) has withdrawn from an agreement announced earlier this year to in-license the glycogen synthase 1 (GYS1) inhibitor MZE001 from Maze Therapeutics, following an administrative complaint by the Federal Trade Commission (FTC), the US antitrust agency. The FTC sought a temporary restraining order and preliminary injunction in federal…
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Sanofi (NASDAQ: SNY) has entered into a partnership with Egyptian biotechnology company Minapharm to locally manufacture and supply its leading anticoagulant, Clexane (enoxaparin). The technology transfer agreement is aimed at enabling the French pharmaceutical giant to navigate “changing market dynamics,” as stated in a press release. Production of the medication…
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Sanofi (NASDAQ: SNY) this week outlined its growth potential for the 2024 to 2025 period, highlighting a pipeline of 12 assets poised to achieve blockbuster status, including three projected to exceed EUR 5 billion in sales. The French pharmaceutical giant anticipates generating over EUR 10 billion in annual pharmaceutical revenues…
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Regeneron Pharmaceuticals (NASDAQ: REGN) and Sanofi (NASDAQ: SNY) have announced that a late-stage replicate trial for their interleukin blocker Dupixent (dupilumab) has successfully met its primary endpoint during an interim analysis. The trial demonstrated a significant reduction in exacerbations over 52 weeks in patients with chronic obstructive pulmonary disease (COPD)…
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BioNova Pharmaceuticals, a Shanghai-based oncology-focused biopharmaceutical company founded in 2018, and Sanofi (NASDAQ: SNY), a leading French pharmaceutical company, have announced a significant agreement. Sanofi has reacquired the exclusive development and commercialization rights to Rezurock (belumosudil), the world’s first ROCK2 inhibitor, in mainland China from BK Pharmaceuticals Ltd and BioNova…
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French pharmaceutical giant Sanofi SA (NASDAQ: SNY) released its Q3 2023 financial results, reporting a net sales decrease of -4.1% year-on-year (YOY) but an increase of 3.2% in constant currency terms, reaching EUR 11.96 billion (USD 12.64 billion). Despite maintaining the forecast for 2023 earnings per share (EPS) growth, Sanofi…
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France-based pharmaceutical giant Sanofi (EPA: SAN) has entered into a strategic partnership with US biotech firm BioMap, an AI-driven drug discovery platform founded by Robin Li, CEO of Chinese internet leader Baidu (NASDAQ: BIDU; HKG: 9888), and Wei Liu, CEO of Baidu Ventures. The collaboration includes an upfront payment of…
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Sanofi (NASDAQ: SNY) has entered into a collaboration agreement with Teva (NYSE: TEVA) for the joint development and commercialization of Teva’s Phase II drug candidate, TEV’574, targeting inflammatory bowel diseases (IBD). This investigational molecule is designed as a potential best-in-class anti-TL1A therapy aimed at treating ulcerative colitis (UC) and Crohn’s…
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Sanofi’s (NASDAQ: SNY) next-generation enzyme replacement therapy (ERT), Nexviazyme (avalglucosidase alfa), has received marketing approval from the National Medical Products Administration (NMPA) as a long-term treatment for Pompe disease. This marks Sanofi’s second drug approved for Pompe disease in China, following the approval of Myozyme (alglucosidase alfa) in October 2015.…
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The Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) has entered into a strategic partnership with Sanofi (NASDAQ: SNY) to develop and commercialize a groundbreaking 9-valent vaccine targeting extraintestinal pathogenic Escherichia coli (ExPEC). Currently in late-stage trials, this vaccine aims to prevent invasive E. coli disease (IED) in adults…
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French pharmaceutical giant Sanofi (NASDAQ: SNY) has announced that it has received marketing approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for its first-in-class drug Altuviiio (Fc-VWF-XTEN fusion protein). This new treatment is indicated for controlling the bleeding tendency in patients with hemophilia A, a genetic disorder that…
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France-based pharmaceutical company Sanofi (NASDAQ: SNY) has announced that it has received another indication approval from the National Medical Products Administration (NMPA) in China for its drug Dupixent (dupilumab), which is now approved to treat prurigo nodosa (PN) in adults. This makes Dupixent the first and only drug approved for…
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The Center for Drug Evaluation has issued a notification concerning the Chemical Generic Drug Reference Preparation Adjustment List, inviting public feedback on the draft proposal before the deadline of October 7, 2023. The list proposes the removal of Ambroxol inhalable solution and four other varieties, totaling nine specifications. Specific Drugs…
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UK-based healthcare company Pharmanovia has announced the expansion of its neurology portfolio through the strategic acquisition of four central nervous system (CNS) products from French pharmaceutical giant Sanofi (NASDAQ: SNY). This move signifies Pharmanovia’s commitment to enhancing its neurology offerings and aligns with Sanofi’s strategy to divest its Consumer Health…