Conor Burke’s Post

#News: Samsung Bioepis Co., Ltd. announced today that the FDA has approved the Biologics License Application (BLA) for #PYZCHIVA® (#ustekinumab-ttwe) #subcutaneousinjection and #intravenousinfusion as a #biosimilar to Stelara1 (ustekinumab). PYZCHIVA has been approved for the treatment of moderate to severe #plaquepsoriasis who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderately to severely active Crohn’s disease, and moderately to severely active ulcerative colitis. Additionally, a provisional determination was granted for PYZCHIVA’s interchangeability. “The FDA approval of PYZCHIVA as a biosimilar to Stelara is an important milestone for patients living with inflammatory conditions, as biosimilars can offer more choice and access to biologic treatments,” said @Byoung In Jung, Vice President and Regulatory Affairs Team Leader at Samsung Bioepis. Read more from BioSpace 👇🏽 https://lnkd.in/eQkT-HtF

In a safety update, Apellis Pharmaceuticals said there has been "no indication" that either drug product or manufacturing issues for #Syfovre (pegcetacoplan injection) triggered recently reported "rare events" of #retinalvasculitis. https://lnkd.in/enBeCFDj #AMD #Apellis #biotechnology #clinicalresearch #GeographicAtrophy #medicalaffairs #ophthalmology #pharmaceuticals

"CAP-1002 for the treatment of DMD has received Orphan Drug Designation and the regulatory pathway for CAP-1002 is supported RMAT (Regenerative Medicine Advanced Therapy Designation). In addition, if Capricor were to receive FDA marketing approval for CAP-1002 for the treatment of DMD, Capricor would be eligible to receive a Priority Review Voucher (“PRV”) based on its previous receipt of a rare pediatric disease designation. Capricor retains full rights to the PRV, if received." #DahliaConsulting #BiopharmaceuticalIndustry #CommercialLifeSciences #ManagementConsultant #LifeSciencesBusinessStrategy #GlobalPharma #GlobalBioTech #SupplychainOperations #CommercialOperations #CGTcommercialization #Manufacturing #QualityAssurance #OperationalExcellence #FinancialAnalysis #OpModelDesign #LifeScience #BioTechnology #Bioprocessing #Biosimilars #BioPharmaIndustry #MedicalResearch #CDMO #GMP #GMPbatch #GMPmanufacturing #GenomeEditing #GeneTherapy #CellTherapy #Car_T #mRNA #cGMP #ClinicalGradeManufacturing #ClinicalGradeProduction #BiologicsLicenseApplication #BLA #Pharmaceuticals #RegenerativeMedicine #CapricorTherapeutics #FDA #CAP_1002 #DuchenneMuscularDystrophy #DMD #RMAT ##RegenerativeMedicineAdvancedTherapyDesignation #PriorityReviewVoucher #PRV

Structure Therapeutics reported its oral GLP-1 drug led to #weightloss in two studies. In a 12-week Phase 2a study, the daily capsule formulation led to 6.2% placebo-adjusted weight loss. In a separate 12-week study, a new tablet formulation, called GSBR-1290 led to placebo-adjusted weight loss of up to 6.9%. Results suggest it is competitive with a once-daily GLP-1 drug currently being developed by Eli Lilly, orforglipron, an oral alternative to the company’s injectable Zepbound or to Novo Nordisk’s injectable Wegovy. Structure plans on initiating a 36-week Phase 2b global #obesity study in Q4 of 2024.

Merck’s #sotatercept would be cost effective for pulmonary arterial hypertension (PAH) if priced between $18,700 and $36,200 per year, according to an analysis by the Institute for Clinical and Economic Review (ICER). https://lnkd.in/gWt4vWsN #ICER #marketaccess #Merck #PAH #pharmaceuticals #pulmonaryhypertension #regulatoryaffairs

Check out our newsletter for the latest news, developments, and regulatory updates. This week's issue includes the new £125 million national research facility led by the University of Liverpool, Scottish-based PhaSER Biomedical's long-term partnership with the Sanders Tri-Institutional Therapeutic Discovery Institute and regulatory updates from the MHRA, FDA and EMA. https://lnkd.in/eY5ReV6Z To receive our newsletters directly to your inbox, just send an email to info@towermains.com with the subject “Weekly Newsletter Please” #drugdevelopment #qualityassurance  #pharmaceutical #regulatory #realworlddata

Filspari Falls Short in Confirmatory Trial for Kidney Condition IgAN, but Travere Aims to Retain FDA Approval Travere Therapeutics' drug, Filspari, initially granted accelerated approval for a rare kidney ailment, fell short in its phase 3 PROTECT trial against irbesartan, casting doubt on full FDA endorsement. While not statistically significant in terms of kidney function, Filspari demonstrated a clinically meaningful difference in eGFR slope and maintained long-term kidney function. Analysts express disappointment and note potential regulatory risks but believe Filspari is unlikely to be withdrawn due to its unique position. However, the results may lead to increased scrutiny on pricing and reimbursement, with Travere's stock declining by around 42%. If you're interested in continuing to read the full story and want to stay updated with the Latest Pharma News in USA, visit Pharmtales. #pharma #pharmaceutical #pharmtales #latestnews #pharmanews #pharmaceuticalindustry #fdaapproval #kidney #fda https://lnkd.in/drF7xD4u

The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Outlook Therapeutics, Inc. regarding the Biologics License Application (BLA) for ONS-5010 (bevacizumab-vikg) for the treatment of neovascular age-related macular degeneration (wet AMD). ONS-5010 is an investigational ophthalmic formulation of bevacizumab, a vascular endothelial growth factor inhibitor (VEGF), under development as an intravitreal injection for the treatment of wet AMD and other retinal diseases. Bevacizumab-vikg works by preventing the interaction of VEGF with its receptors on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation in the retina. “We continue to believe in the public health need to provide the retina community with an FDA-approved bevacizumab treatment option for wet AMD. We will request a formal meeting as soon as possible with the FDA to further understand the BLA deficiencies and how best to resolve them. Following this meeting with the FDA, the Company will be able to discuss next steps and the expected timing for resolution,” said Russ Trenary, President and CEO of Outlook Therapeutics. https://brnw.ch/21wCkTE #CompleteResponseLetter #BiologicsLicenseApplication #ONS5010 #BevacizumabVikg #WetAMD #AgeRelatedMacularDegeneration #NeovascularAgeRelatedMacularDegeneration #VEGF #Ophthalmology #IntravitrealInjection #Retina #EyeHealth #EyeCare

Soft Tissue Sarcoma Pipeline Drugs Analysis Report, 2023: FDA Approvals, Clinical Trials, Therapies, Mechanism of Action, Route of Administration by DelveInsight | OncoTherapy Science, Inc., Foghorn: (Las Vegas, Nevada, United States) As per DelveInsight’s assessment, globally, Soft Tissue Sarcoma pipeline constitutes 125+ key companies continuously working towards developing 130+ Soft Tissue Sarcoma treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and … Continue reading → #Business #HealthMedicine #MarketingSales #PharmaceuticalsBiotech