Eli Lilly Cuts Zepbound Prices for Self-Pay Patients Following White House Deal

Eli Lilly and Company

In a major move to improve affordability and counter the compounded drug market, Eli Lilly has cut the monthly cost of Zepbound to $299 for the starter dose. Available exclusively through LillyDirect, these new single-dose vials offer a significant discount for patients without insurance coverage. Read the full details on the new pricing structure and how it impacts the weight-loss drug market.

Gilead’s Trodelvy Misses Primary Goal in First-Line Breast Cancer Study, But Hope Remains for Overall Survival

Gilead

Gilead Sciences announced its Phase 3 ASCENT-07 trial for Trodelvy® in first-line HR+/HER2-negative metastatic breast cancer did not meet its primary endpoint of progression-free survival (PFS). However, the company reported an “early trend” favoring Trodelvy for the key secondary endpoint of overall survival (OS), and the study will continue to gather more data on this measure.

U.S. FDA Approves KYGEVVI, the First and Only Treatment for Ultra-Rare Mitochondrial Disease TK2d

UCB News

The U.S. FDA granted approval to KYGEVVI for treating adults and children with Thymidine Kinase 2 Deficiency (TK2d), an ultra-rare, life-threatening mitochondrial disease. Developed by UCB, KYGEVVI is the first and only approved therapy for TK2d, demonstrating a profound 86% reduction in the risk of death and significant improvement in motor function for patients with early-onset disease.

U.S. FDA Approves Lilly’s Omvoh (mirikizumab-mrkz) as a Single-Injection Monthly Maintenance Dose for Ulcerative Colitis

Eli Lilly and Company

Eli Lilly has received FDA approval for a new single-injection maintenance dose of Omvoh (mirikizumab-mrkz) for adults with moderately to severely active ulcerative colitis. This approval simplifies the treatment regimen from two monthly injections down to just one, offering the same proven efficacy in a more convenient format. The new 200 mg/2 mL prefilled pens and syringes are expected to be available in the U.S. in early 2026.

Tebipenem HBr Shows Promise as First Oral Carbapenem for Complicated Urinary Tract Infections

GSK - GlaxoSmithKline

Positive data from GSK’s pivotal PIVOT-PO Phase III trial show that oral tebipenem HBr is a promising new treatment for complicated urinary tract infections (cUTIs), including pyelonephritis. The study, which was stopped early for efficacy, demonstrated that the oral antibiotic was non-inferior to the current standard of care, intravenous imipenem-cilastatin. These findings mark a significant step towards the first oral carbapenem for cUTIs, potentially changing the treatment landscape for patients and addressing the challenge of antimicrobial resistance.

Lilly’s Orforglipron, a New Oral Drug, Shows Promise for Type 2 Diabetes and Weight Loss in Late-Stage Trials

Eli Lilly and Company

Eli Lilly has announced positive late-stage trial results for orforglipron, its investigational once-daily oral GLP-1 drug. In Phase 3 studies, orforglipron demonstrated superior blood sugar control and significant weight loss in adults with type 2 diabetes, outperforming other existing medications. These results position it as a potential new standard of care and a convenient oral alternative to injectable treatments.

Lilly’s Omvoh Shows Sustained, Long-Term Efficacy in Ulcerative Colitis and Crohn’s Disease

Eli Lilly and Company

Eli Lilly and Company announced a significant milestone for Omvoh (mirikizumab-mrkz), which is now the first and only IL-23p19 antagonist to demonstrate four years of sustained, corticosteroid-free comprehensive patient outcomes for individuals living with ulcerative colitis (UC).

FDA Approves Groundbreaking Combination Therapy for Extensive-Stage Small Cell Lung Cancer

Roche

In a major breakthrough for oncology, the U.S. FDA has approved a new combination therapy from Roche for a highly aggressive form of lung cancer. The treatment, which combines Tecentriq® (atezolizumab) and lurbinectedin (Zepzelca®), is the first of its kind for the maintenance treatment of extensive-stage small cell lung cancer (ES-SCLC). Clinical trial results show the regimen significantly reduces the risk of disease progression and death, offering new hope and a pivotal shift in how this challenging disease is managed post-chemotherapy.

European Commission Grants Marketing Authorization for Lilly’s Kisunla (donanemab) for the Treatment of Early Alzheimer’s Disease

Eli Lilly and Company

Eli Lilly and Company announced the European Commission has granted marketing authorization for Kisunla (donanemab) to treat early symptomatic Alzheimer’s disease. The therapy demonstrated a significant slowing of cognitive and functional decline and is unique for supporting a finite treatment course.