Sagesse Bio’s Post

Sandoz has received marketing authorization from the European Commission for Pyzchiva® (biosimilar ustekinumab), developed by Samsung Bioepis. Pyzchiva® is approved for use in treating chronic inflammatory diseases within gastroenterology, dermatology, and rheumatology. This approval marks a significant advancement in Sandoz's growth strategy, offering European patients an additional treatment option. The regulatory submission included extensive data from analytical, preclinical, and clinical studies. Sandoz entered a development and commercialization agreement with Samsung Bioepis in 2023, granting Sandoz commercialization rights in various regions while Samsung Bioepis retains responsibilities for development, registration, and manufacturing. Pyzchiva® matches the reference medicine, a monoclonal antibody targeting interleukin (IL)-12/23, for treating autoimmune disorders. #marketintelligence #competitiveintelligence #marketsmind #pharmaceutical #sandoz #ustekinumab

𝗡𝗮𝗻𝗼𝘀𝘂𝘀𝗽𝗲𝗻𝘀𝗶𝗼𝗻𝘀 𝗶𝗻 𝗼𝗽𝗵𝘁𝗵𝗮𝗹𝗺𝗼𝗹𝗼𝗴𝘆: 𝗢𝘃𝗲𝗿𝗰𝗼𝗺𝗶𝗻𝗴 𝗰𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗲𝘀 𝗮𝗻𝗱 𝗲𝗻𝗵𝗮𝗻𝗰𝗶𝗻𝗴 𝗱𝗿𝘂𝗴 𝗱𝗲𝗹𝗶𝘃𝗲𝗿𝘆 𝗳𝗼𝗿 𝗲𝘆𝗲 𝗱𝗶𝘀𝗲𝗮𝘀𝗲𝘀 This review article provides a comprehensive overview of the advancements in using nanosuspensions for controlled drug delivery in ophthalmology. It highlights the significance of ophthalmic drug delivery due to the prevalence of eye diseases and delves into various aspects of this field. The article explores molecular mechanisms, drugs used, and physiological factors affecting drug absorption. It also addresses challenges in treating both anterior and posterior eye segments and investigates the role of mucus in obstructing micro- and nanosuspensions. Read more in the article. #pharmaceutical #nanosuspensions #ophthalmology

Biosimilar OPUVIZ™ Receives Positive CHMP Opinion for Aflibercept-Based Treatment in Ophthalmology The European Medicines Agency's CHMP has issued a positive recommendation for OPUVIZ™, a biosimilar of aflibercept (Eylea), developed by Samsung Bioepis and Biogen. OPUVIZ is recommended for treating retinal disorders such as neovascular age-related macular degeneration, diabetic macular edema, and retinal vein occlusion. The CHMP's decision is based on clinical and non-clinical data showing OPUVIZ's equivalence to aflibercept in terms of efficacy, safety, and pharmacokinetics. If approved by the European Commission, OPUVIZ would improve patient access and healthcare savings, marking Samsung Bioepis’ second ophthalmology biosimilar. For more details please click the link! https://lnkd.in/ghBdPETV #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical 

More than half of #dermatomyositis patients are not optimally managed, according to a survey of 102 U.S. #rheumatologists and #dermatologists by Spherix Global Insights. Currently, the standard of care predominantly involves corticosteroids, topical therapies, traditional disease-modifying anti-rheumatic drugs (tDMARDs), and, in more severe or refractory cases, intravenous immunoglobulin (IVIg) or off-label biologics, underscoring the growing unmet need for novel therapeutic options to treat this condition. https://lnkd.in/djDVjBZS

🚨 NEW TODAY: UCB announced today the FDA approval of bimekizumab-bkzx (Bimzelx) for the treatment of adults with moderate to severe hidradenitis suppurativa (HS). The drug is the first dual IL-17 inhibitor indicated for treatment of the condition. “The approval of bimekizumab is a landmark step in the treatment of hidradenitis suppurativa using multi-targeted biologics," said Christopher Bunick, MD, PhD.

Symbio presents a white paper on Psoriasis on #worldpsoriasisday

The global pharmaceutical market is 1475 billion USD in 2022 growing at a CAGR of 5% during the next six years. In comparison the chemical drug market is estimated to increase from 1005 billion in 2018 to 1094 billion U. S. dollars in 2022. #OrthopedicOncology #CancerTreatment #GlobalHealthcare #MedicalAdvancements #PatientCare #Chemotherapy #Surgery #Hospitals #Clinics #PharmaceuticalIndustry

“In clinical studies, investigational once-daily ZORYVE® foam has demonstrated significant improvements in psoriasis signs and symptoms, effectively and reliably improving both scalp and body psoriasis across all efficacy endpoints compared to vehicle, said Jennifer Soung, MD, director of clinical research at Southern California Dermatology, and clinical trial investigator." #DahliaConsulting #BiopharmaceuticalIndustry #CommercialLifeSciences #PMOStrategies #ManagementConsultant #LifeSciencesBusinessStrategy #GlobalPharma #GlobalBioTech #SupplychainOperations #CommercialOperations #CGTcommercialization #Manufacturing #QualityAssurance #OperationalExcellence #FinancialAnalysis #OpModelDesign #LifeScience #BioTechnology #Bioprocessing #StartupSuccess #CompliancewithPharma #OptimizingBusinessPerformance #Consulting #EfficientProjectDelivery #SuccessThroughPMO #PMO #ProjectManagementExcellence #PMOImplementation #Biosimilars #BioPharmaIndustry #BioPharmaceuticalConsulting #Pharmefex #Collaboration #PharmefexConsulting #MedicalResearch #CDMO #GMP #GMPbatch #GMPmanufacturing #GenomeEditing #GeneTherapy #CellTherapy #Car_T #mRNA #cGMP #ClinicalGradeManufacturing #ClinicalGradeProduction #BiologicsLicenseApplication #BLA #Pharma #Pharmaceuticals #RegenerativeMedicine #ArcutisBiotherapeutics #FDA #SupplementalNewDrugApplication #sNDA #ZORYVE® #Roflumilast #Psoriasis #ClinicalTrials

Grupo SOMAR will be participating in PharmaVenue on January 20-21 in Barcelona! As the #3 local player by volume in the Mexican pharma market, they focus on the entire product lifecycle with a diversified portfolio in Rx, BGx, OTC, and PL. They are seeking partnerships for fixed-dose combinations and innovative pharmaceutical forms to expand in Mexico and Brazil through dossier duplication, licensing, and brand purchases. Looking forward to connecting with industry leaders in dermatology, antibiotics, urology, pain management, and primary care. #GrupoSomar #PharmaVenue #Pharma #Healthcare #Mexico #Brazil #Barcelona #Pharmaceuticals

October 29th was World Psoriasis Day, a day dedicated to supporting patients worldwide who suffer from psoriasis and psoriatic arthritis. Presented by Symbio, we are proud to once again, offer our white paper, “The Clinical State of Psoriasis.” This comprehensive paper explores the latest advancements in psoriasis treatment, including the rise of biologics and their impact on traditional therapies. As the psoriasis market expands to include new systemic agents, clinical trials and their enrollment become increasingly complex. Due to the rise of treatment options such as biologics, topical psoriasis drugs have seen slow enrollment over the last decade. This paper aims to explain why biologics have become so popular and why their introduction has been so disruptive to classic topical drug studies. It discusses the complexities of clinical trials and provides insights into the challenges and future directions in psoriasis management. If you would like to receive a copy of this informative paper, please visit our website at https://lnkd.in/euEUKcuM #WorldPsoriasisDay #GlobalCRO #DermatologyResearch