Kathy Fraser’s Post

BREAKING: Upadacitinib (Rinvoq, AbbVie) bested dupilumab (Dupixent, Sanofi and Regeneron Pharmaceuticals, Inc.) in adults and adolescents with moderate-to-severe #atopicdermatitis who had an inadequate response to or couldn’t tolerate systemic therapy, according to LEVEL UP, an open-label, head-to-head Phase 3b/4 study. https://lnkd.in/dGpiuKYK

This cohort study compared the efficacy and safety of interleukin-17 inhibitors with conventional therapy for patients with erythrodermic psoriasis #Erythrodermic #psoriasis #Biologics https://lnkd.in/gSZ8HYnR

#SpineBiologics Industry is projected to witness a CAGR of 4.3% during the period 2023-2032. This growth can be attributed to the increasing prevalence of spine deformities. #Biologics

Check out the first part of my Pharmaceutical Executive video interview, with Brian Hillberdink, EVP, LEO Pharma and President of LEO Pharma's US affiliate, when he discusses how is LEO Pharma positioning itself to capitalize on the unmet needs, patient centric initiatives, and more

This morning there is excitement at Galderma as we announce that the U.S. Food and Drug Administration (FDA) has accepted our Biologics License Applications for nemolizumab in the treatment of prurigo nodularis and for adolescents and adults with moderate to severe atopic dermatitis.   In addition, the FDA has granted nemolizumab Priority Review for the treatment of prurigo nodularis, a designation granted to medicines with the potential to significantly improve the treatment, diagnosis or prevention of serious conditions. This follows nemolizumab’s Breakthrough Therapy classification for the treatment of pruritus associated with prurigo nodularis, granted in December 2019 and confirmed in 2023.   The European Medicines Agency has also accepted Galderma’s Marketing Authorization Applications for nemolizumab in both prurigo nodularis and atopic dermatitis. This is the start of multiple regulatory submissions that are planned for 2024.   Nemolizumab is a first-in-class investigational monoclonal antibody specifically designed to inhibit IL-31 signaling to provide safe and rapid relief from the most burdensome symptom of both skin conditions: itch.   Since 2019, our journey with this molecule has been the result of incredible teamwork and dedication. We feel privileged to be able to contribute to such advances in dermatology and are excited about its potential impact on patients’ lives in the future.   I invite you to read more on Galderma.com: https://lnkd.in/dbpveY5u   #AdvancingDermatology  #SkinSciencebyGalderma 

Thoughts on this? >> Lilly's lebrikizumab, delayed at FDA, clears eczema in people with skin of color >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #biotech #healthcare #competitivemarketing #pharma #pharmaceutical

Thoughts on this? >> Lilly's lebrikizumab, delayed at FDA, clears eczema in people with skin of color >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharmaceutical #competitivemarketing #pharma #healthcare #biotech

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

“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

Alumis, a biotech company, has announced positive results from its phase 2 trial (STRIDE) of ESK-001, an allosteric tyrosine kinase 2 (TYK2) inhibitor, for treating moderate to severe plaque psoriasis. The trial enrolled 228 participants who received varying doses of ESK-001 or a placebo. ESK-001 demonstrated significant efficacy, with the highest dose showing a 64.1% improvement in the Psoriasis Area and Severity Score (PASI 75) at week 12 compared to placebo. Moreover, the treatment response continued to improve over time, with maximum efficacy observed at week 24 and beyond. ESK-001 was generally well tolerated with mild to moderate adverse events. 𝗔𝗹𝘂𝗺𝗶𝘀 𝗽𝗹𝗮𝗻𝘀 𝘁𝗼 𝗹𝗮𝘂𝗻𝗰𝗵 𝗽𝗶𝘃𝗼𝘁𝗮𝗹 𝗽𝗵𝗮𝘀𝗲 𝟯 𝘁𝗿𝗶𝗮𝗹𝘀 𝗹𝗮𝘁𝗲𝗿 𝘁𝗵𝗶𝘀 𝘆𝗲𝗮𝗿, 𝘀𝘂𝗽𝗽𝗼𝗿𝘁𝗲𝗱 𝗯𝘆 𝗮 𝗿𝗲𝗰𝗲𝗻𝘁 $𝟮𝟱𝟵 𝗺𝗶𝗹𝗹𝗶𝗼𝗻 𝗳𝗶𝗻𝗮𝗻𝗰𝗶𝗻𝗴 𝗿𝗼𝘂𝗻𝗱, 𝘄𝗶𝘁𝗵 𝗮𝗱𝗱𝗶𝘁𝗶𝗼𝗻𝗮𝗹 𝘀𝘁𝘂𝗱𝗶𝗲𝘀 𝘂𝗻𝗱𝗲𝗿𝘄𝗮𝘆 𝗳𝗼𝗿 𝗼𝘁𝗵𝗲𝗿 𝗶𝗻𝗱𝗶𝗰𝗮𝘁𝗶𝗼𝗻𝘀 𝘀𝘂𝗰𝗵 𝗮𝘀 𝘀𝘆𝘀𝘁𝗲𝗺𝗶𝗰 𝗹𝘂𝗽𝘂𝘀 𝗲𝗿𝘆𝘁𝗵𝗲𝗺𝗮𝘁𝗼𝘀𝘂𝘀 𝗮𝗻𝗱 𝗻𝗼𝗻-𝗶𝗻𝗳𝗲𝗰𝘁𝗶𝗼𝘂𝘀 𝘂𝘃𝗲𝗶𝘁𝗶𝘀. The company aims to develop a once-daily tablet formulation for ESK-001. 𝗧𝗵𝗲 𝗽𝗼𝘀𝗶𝘁𝗶𝘃𝗲 𝗱𝗮𝘁𝗮 𝗽𝗼𝘀𝗶𝘁𝗶𝗼𝗻𝘀 𝗘𝗦𝗞-𝟬𝟬𝟭 𝗮𝘀 𝗮 𝗽𝗼𝘁𝗲𝗻𝘁𝗶𝗮𝗹 𝗯𝗲𝘀𝘁-𝗶𝗻-𝗰𝗹𝗮𝘀𝘀 𝗼𝗿𝗮𝗹 𝗧𝗬𝗞𝟮 𝗶𝗻𝗵𝗶𝗯𝗶𝘁𝗼𝗿 𝗳𝗼𝗿 𝗽𝘀𝗼𝗿𝗶𝗮𝘀𝗶𝘀 𝘁𝗿𝗲𝗮𝘁𝗺𝗲𝗻𝘁, 𝗽𝗼𝘁𝗲𝗻𝘁𝗶𝗮𝗹𝗹𝘆 𝘀𝗲𝘁𝘁𝗶𝗻𝗴 𝗮 𝗻𝗲𝘄 𝘀𝘁𝗮𝗻𝗱𝗮𝗿𝗱 𝗳𝗼𝗿 𝗲𝗳𝗳𝗶𝗰𝗮𝗰𝘆 𝗮𝗻𝗱 𝘀𝗮𝗳𝗲𝘁𝘆 𝗶𝗻 𝗼𝗿𝗮𝗹 𝘁𝗵𝗲𝗿𝗮𝗽𝗶𝗲𝘀 𝗳𝗼𝗿 𝘁𝗵𝗲 𝗰𝗼𝗻𝗱𝗶𝘁𝗶𝗼𝗻. #marketintelligence #competitiveintelligence #marketsmind #pharmaceutical #psoriasis