NOVARTIS

Novartis invests $40M in Carlsbad facility for radioligand therapy, creating 30 jobs. Candid Therapeutics launches with $370M for autoimmune disease treatments. Illumina wins EU court challenge over Grail acquisition. Dermtech sold for $1.5M after bankruptcy, continues as private company.

Nivolumab plus gemcitabine/cisplatin chemotherapy significantly improved response rates, overall survival, and progression-free survival in patients with lymph node–only metastatic urothelial carcinoma, according to a post hoc analysis of the CheckMate 901 trial presented at the 2024 ASCO Annual Meeting.

FDA approved Novartis’s Kisqali for early breast cancer, expanding its use to HR+/HER2- stage II and III patients at high recurrence risk. Supported by NATALEE trial data, Kisqali with endocrine therapy reduces recurrence risk by 28.5% after three years. Kisqali, a top-selling therapy, faces competition from Eli Lilly’s Verzenio, both projected to exceed $8bn in sales by 2030.

Global Monoclonal Antibodies Market to reach USD 804.7 billion by 2033, growing at a CAGR of 12.5% from USD 279.8 billion in 2024. Dominated by North America, human-derived antibodies, and oncology applications, with key players including Roche, Novartis, and Johnson & Johnson.

The global mRNA vaccine market is projected to decline at a CAGR of -4.3% from 2024 to 2034, reaching US$ 9.6 billion by 2034. Factors driving market growth include streamlined approval processes, innovations in logistics, increasing public trust, and ongoing research into long-term efficacy. Key players include Pfizer-BioNTech, Moderna, and Novartis, with North America leading in market share.

FDA grants full approval to Travere Therapeutics’ Filspari (sparsentan) for slowing kidney function decline in adults with primary IgA nephropathy (IgAN), supported by phase 3 PROTECT study results showing significant kidney function preservation over two years compared to irbesartan.

JuneBrain secures $300,000 grant from MDIC to modernize its quality management system, partnering with Compliance Group and Siemens to implement Siemens’ Polarion technology, aiming for FDA clearance and enhanced patient safety.

AAVantgarde Bio appoints Jayashree Sahni, MD, FRCOphth, EMBA as Chief Medical Officer, bringing over 25 years of ophthalmology and drug development experience. Sahni will lead gene therapy programs for inherited retinal disorders, leveraging AAVantgarde's two AAV vector platforms for large gene delivery.

ESMO 2024 in Barcelona will feature discussions on cancer therapeutics, including anticipated presentations on bispecific antibodies and anti-TIGIT therapies. Other topics include radioligand therapies and synthetic lethality assets. Experts are optimistic about the potential of these therapeutic classes, despite past challenges.

The Orphan Drugs Market is projected to grow from USD 225.9 Billion in 2023 to USD 493.21 Billion by 2031, driven by rising prevalence of rare diseases, unmet medical needs, favorable regulatory policies, technological advancements, and growing public and patient advocacy. Key challenges include high R&D costs, limited patient populations, pricing and reimbursement issues, and lack of long-term data. Trends include focus on gene therapies, personalized medicine, stakeholder collaboration, and expansion into emerging markets. North America leads the market, followed by Europe and Asia Pacific.