Tag: Eli Lilly and Company

Regulatory Approval Healthcare & Pharmaceuticals News Oncology

U.S. FDA Grants Full Approval to Lilly’s Jaypirca® for Expanded Use in Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

Eli Lilly and Company

U.S. FDA has granted full approval to Eli Lilly’s Jaypirca (pirtobrutinib) for adults with relapsed or refractory chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). This expanded indication allows the use of the non-covalent BTK inhibitor immediately following prior covalent BTK inhibitor therapy. The decision is bolstered by data from the Phase 3 BRUIN CLL-321 trial, which demonstrated a statistically significant improvement in progression-free survival compared to standard combinatorial therapies.

Healthcare & Pharmaceuticals Anti-obesity Drugs Business News Weight-loss Drugs

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.

Clinical Trials Healthcare & Pharmaceuticals News

Eli Lilly’s Eloralintide Shows Up to 20.1% Weight Loss in Phase 2 Obesity Study

Eli Lilly and Company

Eli Lilly and Company announced positive Phase 2 trial results for eloralintide, its investigational once-weekly, selective amylin receptor agonist. The study met its primary endpoint, showing that adults with obesity or overweight achieved mean weight reductions of up to 20.1% over 48 weeks, compared to 0.4% with placebo. The drug also demonstrated a favorable tolerability profile, with mild-to-moderate gastrointestinal symptoms being the most common adverse events. Lilly plans to advance eloralintide to Phase 3 trials by the end of 2025.

Business Healthcare & Pharmaceuticals News

Eli Lilly to Invest $3 Billion in New Netherlands Facility to Boost Oral Medicine Production

Eli Lilly and Company

Eli Lilly has announced a $3 billion investment to build a new, state-of-the-art manufacturing facility in Katwijk, Netherlands. Located in the Leiden Bio Science Park, the advanced plant will significantly expand the company’s capacity for its growing portfolio of oral medicines, including the oral GLP-1 drug orforglipron.

Business Healthcare & Pharmaceuticals News

Eli Lilly’s Q3 2025 Results Soar: Revenue Jumps 54% on Blockbuster Demand for GLP-1 Therapies; Full-Year Guidance Raised

Eli Lilly and Company

Eli Lilly reported blockbuster Q3 2025 earnings, with revenue hitting $17.6 billion on 54% year-over-year growth. The financial success was overwhelmingly driven by its incretin portfolio, particularly the high-demand GLP-1 drugs Mounjaro and Zepbound, which saw their sales soar. Following the strong performance and R&D momentum including positive Phase 3 data for the oral obesity drug orforglipron Lilly significantly raised its full-year 2025 revenue and EPS guidance.

Artificial Intelligence Business Healthcare & Pharmaceuticals News Technology

Eli Lilly Partners with NVIDIA to Build Pharma’s Most Powerful AI Supercomputer

Eli Lilly and Company

Eli Lilly is building the pharmaceutical industry’s most powerful supercomputer in collaboration with NVIDIA to create an “AI factory.” This massive system, featuring over 1,000 NVIDIA DGX B300 GPUs, will leverage decades of data to train specialized AI models, dramatically accelerating drug discovery and development while running on 100% renewable electricity.

Regulatory Approval Autoimmune Diseases News Regulatory

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.

Clinical Trials News Oncology

Lilly’s Verzenio® Shows Significant Survival Benefit in High-Risk Early Breast Cancer

Eli Lilly and Company

Eli Lilly and Company announced major findings from the seven-year monarchE trial. Their CDK4/6 inhibitor, Verzenio® (abemaciclib), is the first in its class to demonstrate a statistically significant overall survival benefit for patients with HR+, HER2-, high-risk early breast cancer when added to endocrine therapy.

Clinical Trials News Weight-loss Drugs

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.