Boehringer Ingelheim USA Corporation

Biologic drugs for asthma can be used during conception, pregnancy, and breastfeeding with shared decision-making. Use should be recorded in registries, and restarting after birth is recommended if halted. Inactivated vaccinations for infants are safe even if mothers received biologics. Concerns remain due to limited clinical trial data, especially for newer biologics like tezepelumab.

OrsoBio raises $67M to advance weight loss drugs; Vor Bio's CRISPR-edited stem cells show success in AML therapy; Boehringer Ingelheim to test eye drug for geographic atrophy; Novartis licenses capsid from Voyager for gene therapy; Vaxcyte raises $1.3B on positive pneumococcal vaccine data.

Boehringer Ingelheim and CDR-Life report positive Phase I results for BI 771716, an antibody fragment targeting geographic atrophy (GA), meeting safety endpoints. The companies plan to initiate Phase II trials in early 2025, aiming to preserve vision in GA patients, a severe form of AMD leading to irreversible vision loss. BI 771716's design allows optimized retinal penetration and efficacy potential.

M.J.D. has consulted, advised, and spoken for Boehringer Ingelheim, Eli Lilly, Novo Nordisk, Sanofi, Pfizer, AstraZeneca, Zealand Pharma, Carmot/Roche, and Amgen. She has also received grants from AstraZeneca, Novo Nordisk, Boehringer Ingelheim, Janssen, Sanofi-Aventis, and Eli Lilly. J.G. has no competing interests.

Evernorth Health Services will offer a private-label biosimilar of Stelara (ustekinumab) starting in early 2025, with a price over 80% lower than Stelara's list price. The biosimilar will be available for $0 out of pocket for eligible patients through Accredo, potentially saving individual patients around $4,000 per year. Evernorth has already seen strong interest in its private-label Humira biosimilar, with over 25% of eligible Accredo patients using it.

September 1 marked the beginning of Suicide Prevention Awareness Month. For the veterinary profession, the suicide rate is high. This week on dvm360.com: clinical trials for canine cardiac tumors, a wellbeing guide for healthcare workers, Boehringer Ingelheim's acquisition of Saiba Animal Health, a podcast on suicide awareness, and updates on veterinary practices in Australia.

JFK, PL, CCW, TYW, XZ, PMW, SL, LB, ZH, SF, KWC, KR, and SS have various consulting roles, advisory board memberships, or research support from numerous pharmaceutical and medical technology companies.

Incretin-modulating therapies, including Wegovy and Zepbound, are transforming obesity treatment, impacting vital organs and offering a holistic approach to metabolic dysfunction-associated steatohepatitis (MASH). Despite early challenges, therapies like Novo Nordisk's semaglutide show promise in MASH Phase III trials. Dual agonism approaches, such as Zepbound and Boehringer Ingelheim's survodutide, demonstrate significant fibrosis improvement in Phase IIb results. Distinctions in receptor agonism effectiveness for MASH treatment are noted, with GLP-1/glucagon receptor agonists potentially more effective. Multiple companies, including Eli Lilly and Altimmune, are advancing their MASH therapies, with Phase III trials planned for 2024. The competitive MASH treatment pipeline emphasizes diverse mechanisms of action, with incretin-modulating treatments expected to be pivotal in future MASH management.

Viva Biotech's portfolio companies achieve significant milestones: Nerio Therapeutics acquired by Boehringer Ingelheim for $1.3B; Apeiron expands investment in synthetic lethality pipeline; Full-Life Technologies licenses FL-091 to SK Biopharmaceuticals; Arthrosi doses first patient in Phase 3 trial for AR882; VivaVision enrolls first subject in VVN001 Phase III trial.

In 2023, systemic sclerosis market size was USD 1,850M in 7MM, with the US leading. Italy had the largest market in EU4 and UK. The US also had the highest diagnosed cases. Treatments like OFEV and ACTEMRA are approved, but Rituximab showed significant improvements. Emerging therapies, including CAR-T cell therapies, are in development, promising future growth. The disease's severity varies by organ involvement, with lung disease being a major concern.