Matteo Boemi’s Post

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

Sagesse Bio is an early stage pharmaceutical company utilizing RNAi technology to accelerate the clinical development of novel solutions to destroy or remodel undesirable pockets of fat. The company's lead compound, SGY-101, is IND-enabled and currently in Phase II clinical trials for other indications. Sagesse Bio will promptly begin clinical evaluation of SGY-101 with comprehensive scientific and technical support from Sirnaomics which specializes in the development of RNAi technology. Initial indications of interest include body contouring and fat reduction. The strategic goal of Sagesse Bio is to become the leading provider of therapeutic solutions for targeted fat reduction in both medical dermatology and aesthetic medicine. 

“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

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 

Compounded #bevacizumab has been used for many years, and has generally been utilized without negative outcomes to treat retinal disorders. It costs a fraction of the amount for #Lucentis or #Eylea. As a result, it has dominated the biologic market for these ophthalmologic indications, accounting for more than half of market share. The availability of bevacizumab #biosimilars has raised the next logical question: Are compounded biosimilar versions less expensive and just as effective? And as importantly, will retina specialists use them? A new report from Cardinal Health provides some insights. #biosimilar #maculardegeneration #retinalveinocclusion Samsung Bioepis Formycon AG Amgen Pfizer Sandoz Celltrion Inc Amneal Pharmaceuticals https://wp.me/p7gt6c-7zw

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

🚨 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.

This week in MedNess Care for Rare, Malini Gupta follows up with Part II of the alphabetical series, by bringing latest happenings in Acromegaly treatment innovation on A for Acromegaly, Part II. We learned about Acromegaly to be a Rare Disease occurring from an overproduction of GH & IGF1, usually due to a benign tumor on the pituitary. Surgical removal of tumors, or using radiation to shrink tumors when needed, are usually the first lines of treatment. In terms of medication, reduction of GH or IGF levels is primarily targeted, and Somatostatin analogs or SSAs are a standard first-line pharmaceutical treatment in addition to surgery or when surgery isn’t enough. Seven SSA and two GH receptor antagonists (GHRA) are expected to be approved by the FDA by 2032 with steady support from technological advancements like radiosurgery and radiolabeled imaging techniques. 📁Subscribe to get the weekly free newsletter on MedNess Disease Disrupters, Neuro, Rare Diseases, and Diagnostics delivered directly to your inbox at https://lnkd.in/gBN7dVsD ✍️Care for Rare Team Malini Gupta, Ph.D., Author Shalini Roy Choudhury, PhD & Anusha Jayaraman, PhD, Managing Editors Siftjit Kaur, PhD & Himanshi Agarwal, PhD, Social Media Managers

Dr. Christopher Bunick's group found that among the distinct structural properties and molecular mechanisms of action found in IL-23 inhibitors, the epitope surface area correlates most strongly with the PASI-90 scores in April Armstrong, MD MPH et al's 2020 meta-analysis in JAMA Dermatology, with risankizumab having the largest epitope SA, followed by guselkumab, ustekinumab, and lastly, tildrakizumab. #psoriasis #biologics