ABBVIE

BRCA1/2 genes are crucial for DNA repair, with mutations increasing cancer risk. PARP inhibitors (PARPi) target these mutations, showing efficacy in BRCA1/2 mutated cancers and some BRCA wildtype tumors with HRD. FDA-approved PARPi include olaparib, rucaparib, and niraparib, used in ovarian, breast, and other cancers, despite potential hematologic toxicities.

The EU and US show similar biosimilar distribution trends, with the EU having a broader portfolio. Biosimilars are most developed for inflammatory diseases, immunology, and oncology due to high costs and prevalence. The EMA leads in biosimilar approvals, but the FDA's approval rate is faster. Regulatory strategies and patent protections significantly impact biosimilar market access, with the EU benefiting earlier than the US. The FDA's Biosimilar Action Plan aims to improve biosimilar development, approval, and market competition.

LRRC15-targeted antibody-drug conjugates (ADCs) show promise in treating osteosarcoma (OS), with LRRC15-PNU demonstrating superior efficacy over LRRC15-MMAE in inhibiting OS growth in vitro and in vivo. LRRC15 expression, regulated by TGFβ, offers a therapeutic target, especially for high-expressing OS cells, suggesting potential for sensitizing low-expressing cells to ADC treatment.

AbbVie takes over development of Morphic Therapeutic's αvβ6 integrin inhibitors for treating idiopathic pulmonary fibrosis and other fibrotic diseases, exercising a licensing option from a 2018 partnership. Morphic receives a $20M license fee, with potential for more payments upon regulatory approval and commercialization.

Recent developments in biosimilars include Biocon Biologics and Sandoz launching biosimilar competitors, legal settlements affecting biosimilar launches, and legislative efforts to increase biosimilar access. Key events involve adalimumab, ustekinumab, and aflibercept biosimilars, with companies like Amgen, Johnson & Johnson, and Regeneron at the center of legal and market activities.

Bill Maris, founder of Google Ventures and Calico, now leads Section 32, investing in tech, healthcare, and life sciences. He's disappointed with Calico's lack of progress in aging research. Section 32 recently hired ex-Googlers, including Claire Stapleton, known for leading a 2018 Google walkout over sexual-misconduct handling.

Christopher Ma, Brian Feagan, Vipul Jairath, Reena Khanna, Parambir S. Dulai, and William J Sandborn disclose various financial relationships with pharmaceutical companies and research organizations, including grants, personal fees, and other forms of compensation, outside their submitted work. Robert Battat and Parambir S. Dulai report no conflict of interest.

Google's Calico, launched in 2013, aims to combat aging and associated diseases through advanced technologies and drug development, partnering with AbbVie. With a focus on extending human life, Calico's research includes mouse models and yeast cells to understand aging. Despite secrecy, the project reflects Google's interest in radical life extension and technological singularity.

TRIGR Therapeutics expands its immuno-oncology pipeline by licensing TR009, a bispecific antibody targeting VEGF and DLL4, from ABL Bio. TR009 shows promising clinical activity in heavily pre-treated cancer patients. TRIGR plans global development and commercialization, with ABL receiving upfront payments and milestones. The collaboration aims to advance cancer therapy, leveraging both companies' expertise.

The article reviews drugs and medical devices for glioblastoma (GBM) treatment, analyzing their modes of action, including radiation, targeting glioma cells, and immunotherapy. Most treatments are in early development stages, with Optune showing some efficacy. Early diagnosis and improved preclinical studies are emphasized for better treatment outcomes. The article also discusses drug delivery challenges, societal and economic aspects, and the importance of the orphan drug status in accelerating GBM therapy development.