Eli Lilly and Co

FDA approves Eli Lilly's Ebglyss (lebrikizumab-lbkz) for moderate-to-severe atopic dermatitis in adults and children aged 12+, based on ADvocate 1, 2, and ADhere studies showing 38% achieved clear or almost-clear skin at 16 weeks versus 12% with placebo, with 77% maintaining results at one year.

Precision medicine uses genetic, environmental, and lifestyle data to tailor treatments, with AI, CRISPR-Cas9, and mRNA as key trends. AI accelerates genomic analysis and drug discovery, CRISPR-Cas9 offers precise gene editing, and mRNA vaccines expand beyond COVID-19, driving personalized healthcare.

A study in The BMJ reviews drug interventions for migraine, emphasizing triptans' efficacy and need for wider access. Experts highlight the importance of comparing new drugs to current treatments and involving patients in research design. The study also notes limitations in trial heterogeneity and individual patient insights.

Pharmaceutical industry inefficiencies stem from high costs per drug approval, frequent C-level executive changes, and strategic R&D restructuring unrelated to science. AI-drug discovery companies should commit to programs until Phase I completion to avoid waste and maximize patient benefit.

The FDA approved Kisunla (donanemab-azbt), an Alzheimer’s drug targeting amyloid plaques in early-stage patients, potentially stabilizing disease progression. Clinical trials showed significant improvement in cognitive and functional assessments, with 47% of patients potentially stopping therapy after one year. Safety concerns include ARIA, a side effect requiring MRI monitoring. Kisunla costs $12,522 for six months, with Medicare and Eli Lilly offering support. The approval marks a shift in Alzheimer’s management, emphasizing early diagnosis and potentially reducing lifelong treatment.

Novartis' Kisqali gains broad FDA approval for early HR+/HER2- breast cancer, reducing recurrence risk by 25% in NATALEE trial, surpassing Eli Lilly's Verzenio in node-negative cases. Kisqali's potential to reach $7 billion in sales is boosted by this approval.

The FDA approved Ebglyss (lebrikizumab-lbkz), a biologic treatment for moderate-to-severe atopic dermatitis in adults and children 12 years and older. Ebglyss, a once-a-month injectable IL-13 inhibitor, showed significant skin clearance and itch relief in phase 3 trials, with 38% achieving clear or almost-clear skin at 16 weeks. Notably, it proved effective in people of color, addressing a gap in dermatologic treatment data. The drug's cost is $3,500 per pen, with potential copay assistance.

Kyverna appoints Warner Biddle as CEO, Christi Shaw to board. Regenxbio welcomes Mitchell Chan as CFO. Mirador Therapeutics appoints Gregg Gilbert as CFO.

Novartis' Kisqali gets FDA approval for early-stage breast cancer; GSK's vaccines for RSV and shingles co-administered effectively; Novo Nordisk partners with NanoVation for genetic therapies; AstraZeneca's Mene Pangalos joins Omega Funds; Serán Biosciences secures $200M for new facility; Boehringer Ingelheim's nerandomilast shows success in Phase 3 IPF trial.