This week's BioPharm Brief highlights City Therapeutics' efforts to advance its RNAi pipeline with a new financing round, positive Phase 3 data for survodutide in obesity and MASLD, and Lilly's oral GLP-1 Foundayo outperforming oral semaglutide in a landmark head-to-head type 2 diabetes trial.
Kyowa Kirin will present new clinical and real-world evidence on mogamulizumab at the World Congress of Cutaneous Lymphomas, including patient-reported outcomes, comparative effectiveness analyses, biomarker findings, and treatment utilization data in relapsed or refractory mycosis fungoides and Sézary syndrome.
According to Eli Lilly and Company, the extended dosing interval reduces maintenance injections to as few as 6 per year without required topical corticosteroids.
Sanofi has discontinued the Phase 3 MOBILIZE trial of riliprubart in treatment-refractory chronic inflammatory demyelinating polyneuropathy after an interim analysis found the study was unlikely to demonstrate sufficient efficacy. No new safety concerns were identified, and the company is evaluating the future of other ongoing riliprubart studies.
In this episode, Ron Lanton draws on insights from the JP Morgan Healthcare Conference to explain how healthcare investment is shifting from backing novel ideas to funding organizations that can scale, survive regulatory and reimbursement pressure, and embed technology into the operational infrastructure of care delivery.
This week's BioPharm Brief highlights City Therapeutics' efforts to advance its RNAi pipeline with a new financing round, positive Phase 3 data for survodutide in obesity and MASLD, and Lilly's oral GLP-1 Foundayo outperforming oral semaglutide in a landmark head-to-head type 2 diabetes trial.
Eli Lilly reported Phase 3 data showing its oral GLP-1 receptor agonist Foundayo (orforglipron) achieved greater reductions in A1C and body weight than oral semaglutide in the first head-to-head trial of two oral GLP-1 therapies for type 2 diabetes.
City Therapeutics has secured $99.5 million in Series B financing to advance its next-generation RNA interference platform and pipeline, including its Phase 1 Factor XI-targeting candidate for thromboembolic diseases and a planned clinical-stage program for Stargardt disease.
Phase 3 data from Boehringer Ingelheim’s SYNCHRONIZE-1 and SYNCHRONIZE-MASLD trials meet their primary endpoints, with glucagon/GLP-1 dual agonism showing targeted metabolic fat reduction beyond body weight loss at 76 and 48 weeks.
Sanofi secured European approval for a subcutaneous formulation of Sarclisa in multiple myeloma, Pfizer expanded HYMPAVZI's FDA-approved use in hemophilia, and Johnson & Johnson agreed to acquire Firefly Bio to strengthen its KRAS-focused oncology pipeline.
Johnson & Johnson has agreed to acquire Firefly Bio in a $1 billion cash deal, gaining access to the company's Firelink degrader antibody conjugate platform for KRAS-driven cancers. The acquisition strengthens J&J's oncology pipeline and reflects continued industry interest in targeted protein degradation approaches for difficult-to-treat solid tumors.
The FDA has expanded the indication for Pfizer's Hympavzi to include pediatric patients ages 6 to 11 years and people with hemophilia A or B who have inhibitors. The approval makes Hympavzi the first subcutaneous non-factor therapy available for children ages 6 to 11 years with hemophilia B.
The approval is based on phase 3 non-inferiority data from the IRAKLIA study, making isatuximab the first anticancer therapy administered via an on-body injector in the EU.
AI-driven protein design, continuous-learning R&D platforms, mechanistic PK/PD modeling, and automated analytical workflows are now foundational tools reshaping how biopharmaceuticals are discovered, characterized, and delivered.
In this episode of The BioPharm Brief, we cover the FDA approval of Lupin's interchangeable ranibizumab biosimilar Ranluspec, a new iPSC cell therapy manufacturing partnership between Made Scientific and Pluristyx, and emerging research on TIGIT as a potential immunotherapy target in pancreatic cancer.
A Journal of Pancreatology review underscores renewed interest in TIGIT, but clinical evidence remains mixed across solid tumors.
The FDA has approved Lupin’s Ranluspec, an interchangeable biosimilar to Lucentis, for wet AMD, diabetic eye disease, and other retinal conditions.
Made Scientific and Pluristyx will integrate iPSC starting materials with CDMO services for cell therapy development.
As the ADC market races toward a projected $32 billion valuation, manufacturers face a precision imperative, as integrated CDMO partnerships, advanced analytics, and emerging technologies like AI and continuous manufacturing may hold the key to unlocking the next wave of oncology breakthroughs.
Today's biopharmaceutical news highlights an FDA breakthrough designation in spinal muscular atrophy, an expanded oncology collaboration focused on tumor activated bispecifics, and a new biosimilar launch for retinal diseases in Europe.
Agilent’s Dr. Ganesh Bala explains how MAM-based LC–MS peptide mapping has become a foundational analytical tool for ADC and bioconjugate CQA monitoring in this Q&A piece.
Teva launches Ahzantive, an EMA-approved aflibercept biosimilar, in select European markets for wet AMD and other retinal diseases.
CytomX and Regeneron aim to deepen their joint effort to develop protease-activated bispecific immunotherapies designed to improve tumor selectivity and widen the therapeutic window in solid tumors.
The FDA has granted Breakthrough Therapy Designation to Biogen's investigational antisense oligonucleotide salanersen for spinal muscular atrophy, supported by Phase 1b data showing motor function improvements and reduced neurodegeneration in children previously treated with gene therapy.
Daily biopharma update covering RNA exon editing licensing, gene therapy clinical data, and preclinical rare disease collaboration advances across the biotech sector.
As ATMP manufacturing capability matures, the limiting constraint has shifted from development to delivery. An analysis of Sweden's uniquely visible ecosystem identifies structural barriers that cannot be resolved through component-level optimization alone.
IDefine and UT Southwestern will assess a preclinical EHMT1 gene replacement strategy for Kleefstra syndrome.
Lilly adds Ascidian’s RNA exon-editing platform for rare inherited kidney disease targets in a deal with no disclosed clinical data.
Interim phase 1b/2 data from Tenaya Therapeutics’ MyPEAK-1 study showed TN-201 gene therapy was generally well-tolerated and associated with improvements in cardiac remodeling, symptom burden, and functional measures in patients with MYBPC3-associated hypertrophic cardiomyopathy.¹
Today’s BioPharm Brief covers FDA draft guidance aimed at streamlining rare disease gene therapy development, Phase 3 trial updates involving dual survival endpoints in oncology programs, and Eli Lilly’s $1.2 billion licensing deal for a GLP-2 therapy in short bowel syndrome.
