NOVARTIS

The oral proteins and peptides market is projected to grow to $2.86 billion by 2028 at a CAGR of 22.4%, driven by factors like rising chronic diseases, biotechnology investments, and non-invasive treatments. Key advancements include novel oral peptides, AI in drug discovery, and oral insulin formulations.

The inMIND trial showed Monjuvi + Rituxan + Revlimid improved progression-free survival (PFS) to 22.4 months vs. 13.9 months for placebo in R/R follicular lymphoma. Key secondary endpoints also favored the experimental arm. Monjuvi aims to become a new standard-of-care option, with potential competition from other therapies.

Kisqali (ribociclib) in combination with endocrine therapy showed a 28.5% reduction in distant recurrence in HR+/HER2- early breast cancer patients, with benefits extending beyond 3-year treatment. Data presented at SABCS reinforced the importance of adding CDK4/6 inhibitors to endocrine therapy for high-risk patients, regardless of nodal status.

U.S. appeals court upheld a Delaware judge's decision, allowing MSN Pharmaceuticals to launch the first U.S. generic of Novartis' Entresto. Novartis disagrees with the ruling and is considering further appellate options.

Gene therapies offer potential for curing diseases but face hurdles due to high costs, estimated at $20.4 billion annually. Innovative payment models and pharmacist involvement are crucial for equitable access and sustainability.

At the 2024 San Antonio Breast Cancer Symposium, experts discussed FDA approvals for ribociclib and inavolisib in HR+/HER2- BC, emphasizing treatment optimization, clinical trial design, and addressing ovarian/reproductive toxicities. Ribociclib's approval was based on NATALEE trial data showing improved invasive disease-free survival (iDFS) with safety concerns. Inavolisib, targeting PIK3CA mutations, showed improved progression-free survival (PFS) with post-marketing commitments for further evaluation. The session highlighted the need for comprehensive data analysis and monitoring of fertility impacts.

The Parkinson's disease market is expected to grow significantly, reaching USD 6.2 billion by 2034, driven by advancements in diagnostics, disease awareness, and emerging therapies. Key therapies in development include ND0612, tavapadon, P2B001, BIIB122/DNL151, Buntanetap, Solengepras, and Minzasolmin. These therapies aim to improve motor function, manage symptoms, and potentially slow disease progression.

Clinical trials are crucial in India's patent framework for demonstrating inventive step and enhanced efficacy under Sections 2(1)(j) and 3(d) of the Patents Act. They help address objections during patent prosecution, as seen in landmark cases like Novartis AG v. Union of India and Ischemix LLC v. Controller of Patents. Applicants should submit additional clinical data, align it with patent specifications, and engage with patent controllers to navigate objections effectively.