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Sandoz Receives EC Approval for Biosimilar to Eylea for Retinal Diseases
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Switzerland-based pharmaceutical company Sandoz (SWX: SDZ) has announced that it has received marketing approval from the European Commission (EC) for its biosimilar of Bayer/Regeneron’s (ETR: BAYN / NASDAQ: REGN) Eylea (aflibercept). The product is now available in the form of a 2 mg vial kit and pre-filled syringe for intravitreal…
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Regeneron Pharmaceuticals Reports 11% YOY Revenue Growth in Q3 2024
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US-based Regeneron Pharmaceuticals (NASDAQ: REGN) has reported its financial details for the third quarter of 2024, with revenues reaching USD 3.72 billion, marking an 11% increase year-on-year (YOY). Product sales grew by 9% YOY to USD 1.946 billion, while collaboration revenues stood at USD 1.774 billion, up 12.5% YOY. In…
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Dupixent Secures Back-to-Back COPD Approvals from US FDA and China NMPA
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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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Regeneron Secures EU Approval for Ordspono, Its First Bispecific Antibody
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Regeneron Pharmaceuticals Inc. (NASDAQ: REGN) has secured its first global market approval for Ordspono (odronextamab) from the European Commission (EC). This marks a significant milestone as Ordspono becomes the company’s first bispecific antibody (BsAb) to receive approval, designated for the treatment of adult patients with relapsed or refractory (R/R) follicular…
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Regeneron’s Linvoseltamab Faces FDA Complete Response Letter, Awaiting Reinspection of Manufacturer
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Regeneron Pharmaceuticals Inc., a leading biopharmaceutical company based in the US and listed on the Nasdaq (NASDAQ: REGN), has encountered a setback in its pursuit of market approval for the bispecific antibody (BsAb) linvoseltamab. The US FDA has issued a Complete Response Letter (CRL) regarding the company’s filing for this…
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Huadong Medicine’s Arcalyst Filing for Recurrent Pericarditis Accepted by China’s NMPA
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Huadong Medicine Co., Ltd, (SHE: 000963) a Chinese pharmaceutical company, has announced that the National Medical Products Administration (NMPA) in China has accepted for review its market approval filing for the injectable Arcalyst (rionacept). The drug is indicated for the treatment of recurrent pericarditis (RP) in adults and adolescents aged…
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Regeneron Pharmaceuticals Acquires 2seventy Bio to Boost Cell Therapy Capabilities
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Regeneron Pharmaceuticals (NASDAQ: REGN) has announced the acquisition of U.S. biotechnology company 2seventy Bio Inc. (NASDAQ: TSVT), securing all development and commercialization rights to the latter’s drug discovery platform, clinical manufacturing platform, and investigational innovative cell therapies. In conjunction with this acquisition, Regeneron will establish a new unit, Regeneron Cell…
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Dupixent by Sanofi and Regeneron Approved by FDA for Eosinophilic Esophagitis in Younger Pediatric Patients
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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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Dupixent Trial Success Reinforces Potential in Moderate-to-Severe COPD Treatment
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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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Regeneron Pharmaceuticals Acquires Decibel Therapeutics to Advance Hearing Loss Treatments
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Regeneron Pharmaceuticals (NASDAQ: REGN) has completed the acquisition of Decibel Therapeutics, a developer of gene therapies for hearing loss, following an agreement reached last month. This strategic move expands Regeneron’s portfolio in the field of genetic therapies and underscores the company’s commitment to addressing hearing loss conditions. Decibel’s Pipeline and…
