Boehringer Ingelheim USA Corporation

The Nasal Drug Delivery Technology Market is projected to grow from USD 4.4 billion in 2024 to USD 7.8 billion by 2031, driven by non-invasive drug administration, technological advancements, and rising respiratory disease prevalence.

Biopharma layoffs continue into 4Q 2024, affecting companies like Thermo Fisher, Charles River, Pfizer, Evonik, Johnson & Johnson, Bayer, Bristol Myers Squibb, AGC Biologics, and others. These layoffs are part of restructuring initiatives, site closures, and focus shifts in strategic core growth areas.

Zongertinib (BI 1810631; Boehringer) received breakthrough therapy designation for NSCLC with HER2 mutation. It may be the first TKI for metastatic, advanced, or unresectable NSCLC with HER2 mutations. Phase 1b Beamion LUNG-1 trial showed 66.7% ORR and tolerability, with ongoing phase 3 Beamion LUNG-2 study comparing it to standard-of-care treatment.

Liposarcoma, a common subtype of soft tissue sarcoma, includes dedifferentiated liposarcoma (DDLPS) with high MDM2 amplification. Brigimadlin, an MDM2-p53 antagonist, showed stable disease in 75% of patients in a phase 1a/1b study. A phase 2/3 Brightline-1 trial compares brigimadlin to doxorubicin in advanced DDLPS, aiming to identify optimal dosing and assess progression-free survival.

J.P.-G. consults for Lilly, Roche, Eisai, Daiichi Sankyo, AstraZeneca, Seattle Genetics, Gilead, MSD; receives travel compensation from Roche; employed by MEDSIR. G.A. receives honoraria from MEDSIR. M.G. receives travel support and honoraria from AstraZeneca, Gilead Sciences, Roche, Pfizer. A.L.-C. receives research support, consults, speaks, and travels for Roche, Lilly, Pfizer, Novartis, Merck Sharp & Dohme, Gilead, Daiichi Sankyo; owns MEDSIR, Initia-Research. J.C. consults, receives honoraria, research funding, stock, travel expenses, and patents for Roche, Celgene, Cellestia, AstraZeneca, Seattle Genetics, Daiichi Sankyo, Erytech, Athenex, Polyphor, Lilly, Merck Sharp & Dohme, GSK, Leuko, Bioasis, Clovis Oncology, Boehringer Ingelheim, Ellipses, HiberCell, BioInvent, GEMoaB, Gilead, Menarini, Zymeworks, Reveal Genomics, Expres2ion Biotechnologies; holds patents for pharmaceutical combinations.

Digital health startups Aignostics, TCC, Yazen Health, Nema Health, Alimetry, and Research Grid secure significant funding. Aignostics raises $34M for AI in digital pathology, TCC gets €20M for ICU telemedicine, Yazen Health secures €19.5M for obesity care platform, Alimetry receives $18M for GI disorder diagnostics, Nema Health raises $14.5M for PTSD treatment, and Research Grid collects £5M for clinical trial automation.

The digitization of pharma pipelines, integrating digital therapeutics with traditional pharmacotherapy, is set to revolutionize drug treatments. This shift will enable personalized, adaptive therapies, enhancing patient outcomes and creating new market pathways. Recent FDA guidance supports 'added benefit claims' for software-enhanced drugs, fostering partnerships between pharma and tech-bio companies. Clinical data validates the efficacy of digital therapeutics, suggesting they could become standard care, offering significant value beyond traditional drugs.

Experts discuss tirzepatide's safety and benefits after a UK death linked to the drug, highlighting the need for high-quality trials and the importance of the 'yellow card scheme' for reporting side effects.