Don Tracy, Associate Editor

Dupixent is the first new targeted therapy to receive FDA-approval for chronic spontaneous urticaria in adults and adolescents over 12 years of age in over a decade.

Regulatory action was based on data from the Phase III QUASAR trial, which demonstrated that Eylea HD dosed every eight weeks achieved non-inferior visual acuity outcomes compared to Eylea in patients with macular edema following retinal vein occlusion.

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted to expand access to Pfizer’s respiratory syncytial virus vaccine Abrysvo for high-risk adults in their 50s and voted in favor of GSK’s meningococcal vaccine, Penmenvy, for streamlined adolescent protection.

A new study found that patients with type 2 diabetes treated with GLP-1 receptor agonists and sodium-glucose cotransporter-2 inhibitors demonstrated lower risks of developing Alzheimer disease compared to other glucose-lowering drugs.

Nigel McCracken, chief operating officer, Virax Biolabs, discusses new findings that reveal altered cytokine activity and evidence of T cell exhaustion in long COVID patients, providing deeper insight into post-infection immune disruption.

Ziresovir is the first antiviral to demonstrate significant clinical efficacy and long-term respiratory benefits in hospitalized infants under six months of age with respiratory syncytial virus.

In the Phase III DeLLphi-304 trial, patients with small cell lung cancer administered Imdelltra achieved a statistically significant and clinically meaningful improvement in overall survival compared to standard-of-care chemotherapy.

In the Phase III ODYSSEY-HCM trial, patients treated with Camzyos for symptomatic non-obstructive hypertrophic cardiomyopathy did not show significant improvements based on Kansas City Cardiomyopathy Questionnaire – Clinical Summary Scores and peak oxygen consumption.

Nigel McCracken, chief operating officer, Virax Biolabs, discusses results from new data on the role of T cell dysfunction in post-acute infection syndromes.

Despite meeting key pharmacokinetic goals, a potential case of drug-induced liver injury led Pfizer to conclude that danuglipron’s risk-benefit profile did not support further development for chronic weight management.

Odylia Therapeutics event brings together leaders across biotech, pharma, venture capital, patient advocacy, and research sectors to address the financial and structural barriers that impede rare disease drug development.

Approval of Opdivo plus Yervoy combination was based on results from the Phase III CheckMate-9DW trial, which demonstrated significantly improved overall survival and overall response rate in patients with unresectable or metastatic hepatocellular carcinoma.

Investment is expected to bring approximately 1,000 new jobs at Novartis and 4,000 additional roles across the United States.

Full approval of Vitrakvi was based on results from three clinical trials in patients with unresectable or metastatic NTRK fusion-positive solid tumors.

In the Phase III ICONIC-LEAD trial, 75% of adolescents with moderate-to-severe plaque psoriasis treated with icotrokinra achieved completely clear skin by week 24.

Financing of Merida Biosciences was backed by Bain Capital Life Sciences, BVF Partners and Third Rock Ventures, with participation from multiple other investors.

Davidi Vortman, CEO, UltraSight, discusses how AI-powered heart scan technology can help high-risk cardiovascular disease patients.

PharmaLogic states that the acquisition of Agilera Pharma AS will place the company in a unique global role in radiopharmaceutical production and distribution.

Approval of the Opdivo plus Yervoy combination regimen was based on results from the Phase III CheckMate-8HW trial, which was the largest immunotherapy study in patients with previously untreated, unresectable, or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer.

Brimochol PF, a combination of brimonidine and carbachol, was found to enhance depth of focus and visual acuity in clinical trials among patients with presbyopia.

Results from Phase II studies demonstrated that rilzabrutinib showed clinically meaningful outcomes in patients with warm autoimmune hemolytic anemia and IgG4-related disease.

Results from the Phase III SPACE trial show that Ajovy significantly reduced monthly migraines in pediatric patients between six and 17 years of age.

Enrollment for the Phase II trial follows FDA clearance of SPG302 Investigational New Drug application for schizophrenia.

Approval was based on results from the Phase III ALIGN study, which demonstrated a significant reduction in proteinuria at 36 weeks in patients with primary immunoglobulin A nephropathy.

Results from the Phase III ZENITH trial show that Winrevair lowered the risk of all-cause death, lung transplantation, and pulmonary arterial hypertension-related hospitalization by 76%.

Results from the SOLARIS trial survey showed that over 92% of patients, 87% of nurses, and 72% of physicians expressed satisfaction with TEV-'749’s initiation regimen, dosing schedule, and overall treatment experience.

BIIB080 marks the first antisense oligonucleotide targeting tau to enter clinical development for the treatment of Alzheimer disease.

In the SOUL trial, Rybelsus produced a 14% risk reduction of major adverse cardiovascular events in patients with type 2 diabetes and cardiovascular disease and/or chronic kidney disease.

The trial size adjustment, along with protocol modifications and the addition of higher-enrollment sites, is expected to facilitate completion of the NEPHRO CRRT study of Niyad in patients undergoing renal replacement therapy by the end of 2025.

Qfitlia is the first FDA-approved antithrombin-lowering therapy indicated for routine prophylaxis to prevent or reduce bleeding episodes in patients over 12 years of age with hemophilia A or B.