NOVARTIS

DPHARM 2024 focused on innovations in clinical trials, featuring keynotes on ROI, DCTs, AI, and patient perspectives. Panels discussed efficiency, AI use, and ecosystem approaches. Outside-industry speakers offered insights on decision-making and innovation mindset. Technologists and sponsors highlighted patient-centric services and strategic collaborations. DPHARM Idol Disrupt showcased new technologies, with Power winning for a patient-matching platform. The event aimed to improve trial efficiency and deliver life-changing medicines.

Cybin Inc. appoints Dr. Mirza Rahman as SVP, Patient Safety & Pharmacovigilance, and Dr. Marcelo Gutierrez as VP, Clinical Pharmacology, in preparation for Phase 3 trial of CYB003 for MDD.

The global organoids and spheroids market was valued at US$ 905.14 million in 2023 and is projected to reach US$ 5,581.47 million by 2032 at a CAGR of 22.42%. Key drivers include the increasing demand for 3D cell models in drug discovery, technological advancements, and the growing emphasis on alternatives to animal testing. Emerging trends such as personalized medicine and high-throughput screening are revolutionizing treatment paradigms. The market is poised for transformative impacts, with significant government funding and collaborative efforts fueling advancements.

Breakthrough Therapy Designation Market to double by 2032, driven by 13.5% CAGR, fueled by pharmaceutical companies seeking faster FDA approval for serious condition treatments. Key players include AbbVie, Amgen, AstraZeneca, and others. Market challenges include high clinical trial costs and stringent regulatory requirements.

FDA approves Novartis' Kisqali for HR+/HER2- early breast cancer, reducing recurrence risk by 25.1% in NATALEE trial. Kisqali, combined with aromatase inhibitor, targets high-risk stage II and III patients, including those with node-negative disease. Treatment involves 400 mg daily for 3 weeks, followed by 1 week off, over 3 years.

Siemens Healthineers received FDA premarket approval for 3D technology in its Mammomat B.brilliant mammography system, featuring PlatinumTomo for clearer 3D imaging and UltraHD for better calcification visualization, enhancing diagnostic capabilities and patient comfort.

Genentech to acquire Regor Therapeutics Group's next-gen CDK 4/6 inhibitors, including Phase I candidate RGT-419B for breast cancer treatment, aiming to compete with blockbuster drugs Ibrance, Verzenio, and Kisqali. Regor to receive $850m upfront and potential milestone payments. Genentech to handle global development, manufacturing, and commercialization; Regor to manage ongoing Phase I trials. Transaction expected to close Q4 2024.

Teva Pharmaceutical Industries launched its generic Sandostatin LAR, an acromegaly treatment, with potential $200 million annual revenue. BofA Securities reaffirmed its Buy rating and $22.00 price target. Teva's generic is the first to market, facing competition from Viatris. The launch is expected to boost Teva's financials in 2024-25, supported by other positive portfolio results. Teva also settled an $80 million opioid litigation and saw a 11% revenue growth in Q2 2024.

S.B., A.D., T.J.F., I.M.G., L.G., R.K.J., G.K., J.M.L., G.V.L., K.P.-J., H.I.S., J.T., R.R.W., M.W., Y.L.W. have disclosed various financial interests, including funding, advisory roles, patents, and equity. C.M.B., E.B., M.W.B., and K.P. declare no competing interests.