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Immunome has dosed the first patient in a Phase 1 clinical trial evaluating IM-1617, a potential first-in-class antibody-drug conjugate incorporating the company's proprietary HC74 topoisomerase I inhibitor payload. The study will assess safety and preliminary anti-tumor activity in patients with advanced solid tumors.

FDA has approved Organon's tocilizumab-bavi (Tofidence) for CAR T-cell–induced CRS and hospitalized COVID-19 in adults and children aged 2 years or older.

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.

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.