NOVARTIS

Firefly Neuroscience announced advancements in its AI-powered Brain Network Analytics (BNA™) technology, following successful collaborations with Takeda and Novartis. BNA™ aims to accelerate drug development by providing objective measures of brain activity, enhancing trial design, and reducing costs. Firefly plans to expand partnerships with neuroscience pharmaceutical companies.

The global Biotechnology Market is projected to reach USD 6.24 trillion by 2032, driven by R&D investments, healthcare demand, and advancements in pharmaceuticals, agriculture, and environmental management.

The Outsourcing In Clinical Trials New England Conference, held on 23–24 October in Boston, will address biotech layoffs, regulatory changes, and AI advancements in drug development. Panels will discuss layoffs, economic shifts, FDA measures, and AI's impact on clinical trials, including patient recruitment and drug discovery.

Recent cancer research breakthroughs include Oncolytics Biotech's BRACELET-1 study showing promising results for pelareorep in HR+/HER2- breast cancer, Novartis AG's FDA approval of Kisqali for early-stage breast cancer, Lantheus Holdings' positive Phase 3 SPLASH trial results for 177Lu-PNT2002 in prostate cancer, Sutro Biopharma's encouraging Phase 1b study data for Luvelta in ovarian cancer, and Zymeworks' upcoming presentation of preclinical data on its antibody-drug conjugate programs.

DelveInsight's 'Adrenoleukodystrophy Pipeline Insight, 2024' report details 11+ treatment therapies by 10+ companies, including Autobahn Therapeutics, Viking Therapeutics, and SwanBio Therapeutics. Emerging therapies like ABX-002, VK0214, and SBT101 are expected to impact the market. Minoryx Therapeutics plans to re-examine Nezglyal's approval after CHMP's refusal.

AI revolutionizes drug discovery by enhancing efficiency and accuracy in identifying drug candidates and predicting pharmacological properties. It integrates machine learning and deep learning to optimize decision-making and accelerate drug design, despite challenges like data privacy and model interpretability. AI's potential in uncovering therapeutic targets and repurposing drugs is significant, with applications in target identification, lead optimization, and predictive modeling.

Regulatory snapshots: global drug submissions, approvals, clinical trial approvals, and other decisions involving Accord, Applied, Astrazeneca, Azitra, Briacell, Glycomine, Imcheck, Merck, Moderna, Nicox, Novartis, Valneva.

FDA approves Kisqali (ribociclib) with aromatase inhibitor for HR+/HER2- stage II/III early breast cancer, reducing recurrence risk by 25.1% in NATALEE trial. Kisqali, a CDK4/6 inhibitor, is taken orally for three years, showing a well-tolerated safety profile. The approval broadens treatment options for high-risk patients, including those with N0 disease.

FDA expands approval of Kisqali for early-stage breast cancer, reducing recurrence risk by 25% after 3 years and 28.5% after 4 years. The drug is now available for HR-positive, HER2-negative breast cancer patients in stages 2 and 3, with potential long-term benefits and high costs.