--- title: 'Life Sciences Daily Summary: What Happened on October 5, 2026' headline: Tozorakimab cuts COPD flare-ups in two Phase 3 trials description: The FDA expanded Lilly’s Jaypirca label as drug tariffs took effect and companies announced manufacturing and licensing plans. url: https://thebench.bio/news/summaries/2026-10-05 topic: all date: '2026-10-05' covers: - '2026-10-05' date_published: '2026-10-05T12:03:56Z' date_modified: '2026-10-05T12:03:56Z' sources: 8 publisher: The Bench (thebench.bio) --- # Life Sciences Daily Summary: What Happened on October 5, 2026 **Tozorakimab cuts COPD flare-ups in two Phase 3 trials** The FDA expanded Lilly’s Jaypirca label as drug tariffs took effect and companies announced manufacturing and licensing plans. ## Today in brief AstraZeneca said tozorakimab reduced COPD exacerbations in two Phase 3 trials, with the strongest effects among patients with high eosinophil counts. [1] [2] The FDA approved Lilly’s Jaypirca as an initial treatment for some adults with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma who lack a 17p deletion. [3] Since September 29, tariffs of up to 100% have applied to patented medicines and their ingredients, leaving companies uncertain about compliance and exemptions. [4] Bayer plans a $2.2 billion Ohio manufacturing site, while Shionogi bought IntraBio in a deal valued at $2 billion. [5] [6] ## Tozorakimab lowered COPD exacerbations in two Phase 3 trials The OBERON and TITANIA trials found that tozorakimab reduced moderate or severe COPD exacerbations compared with placebo, alongside standard inhaled treatment. [1] [2] Among former smokers in the primary efficacy group, annual exacerbation rates ranged from 1.34 to 1.37 with tozorakimab and from 1.90 to 2.07 with placebo. [1] Across current and former smokers, AstraZeneca said exacerbations fell by as much as 30% in the two trials. [1] [2] Tozorakimab appeared to have its strongest effect in participants with blood eosinophil counts of at least 300 cells per microliter, with smaller reductions at lower counts. [1] [2] Side effects were broadly similar between groups, apart from more injection-site reactions with tozorakimab. [1] Investigators did not consider the deaths and cardiovascular events observed in the trials to be related to the drug. The tozorakimab group had 13 serious cardiovascular events or adverse events resulting in death, compared with five in the placebo group. [1] Tozorakimab did not significantly improve lung function or quality-of-life measures, which dupilumab has improved in COPD studies. [1] AstraZeneca has submitted tozorakimab for FDA review and expects a decision in the first quarter of 2027. [1] ## FDA approves Jaypirca for initial treatment of some CLL and SLL The FDA approved Lilly’s oral drug Jaypirca for adults with untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who lack a 17p deletion. [3] The decision rested on the Phase 3 BRUIN CLL-313 trial, which compared pirtobrutinib, Jaypirca’s generic-name drug, with bendamustine plus rituximab. [3] After a median 28 months of follow-up, median progression-free survival had not been reached with pirtobrutinib, versus 33.5 months with the comparison regimen. [3] Overall response rates were 94% with Jaypirca and 81% with the comparator. [3] Serious adverse reactions included pneumonia among patients taking Jaypirca. [3] Adverse events led to dose reductions in 3.6% of patients and treatment discontinuations in 4.3%. [3] ## Drug tariffs are in force, but companies still face compliance questions Patented medicines and their ingredients have faced tariffs of up to 100% since September 29. [4] On October 5, biotechnology companies and industry experts described uncertainty about which products qualify and how to seek exemptions. [4] Department of Commerce guidance says exemption reviews may consider the disease treated, alternative therapies, the number of U.S. patients, and availability in other countries. [4] Officials will review each request individually, with no deadline for decisions. [4] Experts warn that tariffs and reporting costs could divert money from research and make medicines harder to access. [4] A Wall Street Journal editorial cited one small company’s estimate that compliance could use 2% to 4% of its working capital before its first medicine reaches the market. [4] ## Bayer plans a $2.2 billion Ohio manufacturing site Bayer plans to invest $2.2 billion in a pharmaceutical manufacturing facility at New Albany International Business Park in Ohio. [5] The planned site would make drug substances and finished medicines for cardiovascular, cancer, and kidney treatments. [5] Bayer expects the first drug-substance module to open in 2031 and a drug-product unit in 2034. [5] Construction is expected to create nearly 1,500 jobs, and the operating facility is projected to support about 600 roles. [5] ## CSL pays Alentis $355 million upfront for claudin-1 drug rights CSL will fund development of lixudebart, Alentis Therapeutics’ claudin-1 drug, through an exclusive global partnership. [7] Alentis will receive $355 million upfront and could earn up to another $1.2 billion in commercial milestone payments. [7] If lixudebart reaches the market, CSL would receive 55% of global profits and Alentis 45%. [7] The companies plan Phase 2 studies in focal segmental glomerulosclerosis and primary sclerosing cholangitis. [7] ## Also worth knowing - The FDA approved a gene therapy for a rare lysosomal storage disorder. [8] ## The day in numbers - **1.34–1.37 vs. 1.90–2.07**: Annual moderate or severe COPD exacerbations among former smokers in the tozorakimab and placebo groups, respectively. [1] - **100%**: Maximum tariff rate on patented medicines and their ingredients, in effect since September 29. [4] - **$2.2 billion**: Bayer’s planned investment in its Ohio manufacturing site. [5] - **$355 million**: Upfront payment to Alentis in its partnership with CSL for lixudebart. [7] ## Sources 1. [COPD trial wins spur broad respiratory hopes](), Nature Reviews Drug Discovery, 2026-10-05 2. [AstraZeneca’s tozorakimab cuts COPD exacerbations by up to 34% in phase 3 trials](), Pharmafile, 2026-10-04 3. [FDA approves expanded indication for Lilly’s Jaypirca](), Pharmaceutical Technology, 2026-10-05 4. [Tariffs’ drag on innovation compounded by lack of guidance, experts say](), Bio.News, 2026-10-05 5. [Bayer plans $2.2bn pharmaceutical manufacturing facility in Ohio, US](), Pharmaceutical Technology, 2026-10-05 6. [Shionogi's diversification continues with $2bn IntraBio buy](), pharmaphorum, 2026-10-05 7. [CSL backs Swiss Alentis’ claudin-1 bet with up to $1.6bn deal](), European Biotechnology, 2026-10-05 8. [Gene therapy for rare lysosomal storage disorder nabs FDA approval](), Nature Reviews Drug Discovery, 2026-10-05 --- The Bench wrote this from the reporting cited above, with a language model drafting and editing. [1]: [2]: [3]: [4]: [5]: [6]: [7]: [8]: