NOVARTIS

The FDA approved Roche's subcutaneous formulation of Tecentriq, branded as Tecentriq Hybreza, making it the first SC anti-PD-(L)1 cancer immunotherapy in the U.S. The SC option reduces treatment time to about 7 minutes compared to 30-60 minutes for IV infusion and is available for all Tecentriq indications.

Roche's injectable Ocrevus, approved by FDA, shortens MS treatment time from hours to 10 minutes, available from October, reducing need for specialized infusion centers and potentially aiding competition defense.

AI significantly aids in identifying suitable patients for clinical trials, especially in rare diseases, by leveraging global registries and natural history studies to match patient cohorts with trial criteria, expediting recruitment and optimizing trial outcomes.

Personalized medicine market to reach $900.67 Bn by 2030, driven by cancer therapies and genetic tech. North America leads, emphasizing personalized nutrition and expanding therapeutic applications.

A.A. (UCSF, NIH T32 grant, past consulting income from LeMaitre and MIS Technologies) and D.R. (FDA) have no conflicts of interest. L.H.C. (Duke, FDA, past consulting income from Regeneron, NFLPA, Boehringer, institutional grants from GSK, Novartis) also has no conflicts. R.M.C. (FDA, former Verily Life Sciences, Google Health employee, held equity, served on boards of Cytokinetics, Centessa, Clinetic, Keystone Symposia, C-Path, Clinical Research Forum, One Fifteen) discloses no conflicts related to this manuscript.

The FDA approved Roche's subcutaneous injection, Tecentriq Hybreza, for treating multiple sclerosis, expanding use to centers without IV capabilities. The 7-minute injection, given twice yearly, is non-inferior to the IV version Ocrevus, targeting CD20-positive B cells. Ocrevus IV sales reached 6.38 billion Swiss francs in 2023.

Large drug-maker stocks surged, driven by FDA approvals and pipeline innovations. Eli Lilly, Roche, Novartis, and Pfizer are top picks for long-term gains. Eli Lilly's tirzepatide drugs and Novo Nordisk's semaglutide drugs are top sellers. Despite M&A scrutiny, activities remained strong. Large drug-makers offer robust revenue streams and profitability.

Psychiatry faces a high-stakes experiment with psychedelics, which could revolutionize treatments but risks damaging credibility if unsuccessful. The field nearly faced extinction in the 1960s due to anti-psychiatry movements and Freudian disenchantment, but was saved by scientific method. Now, psychedelics, once banned, are being reconsidered for their therapeutic potential, though concerns remain about scientific rigor and commercial opportunism.

AI in pharma could boost global operating profits by $254 billion by 2030, revolutionizing drug discovery, clinical trials, and personalized medicine. Key benefits include accelerated drug discovery, personalized care, enhanced clinical trials, optimized manufacturing, and advanced biomarker discovery. Real-world examples from companies like AstraZeneca, GSK, Novartis, and Sanofi highlight AI's transformative impact. Challenges include reproducibility, data quality, privacy, bias, and regulatory compliance, but solutions involve standardized datasets, data-sharing, encryption, diverse data sources, and proactive regulatory engagement.

Ractigen Therapeutics receives FDA orphan drug designation for RAG-18, a saRNA for DMD/Becker muscular dystrophy. Biogen's nusinersen shows higher dose efficacy in SMA. Cartesian Therapeutics initiates Descartes-15 CAR-T phase 1 trial for r/r multiple myeloma. Imugene's azer-cel CAR-T produces complete responses in r/r diffuse large B cell lymphoma. Novartis licenses Voyager Therapeutics' capsid for neurological target. BridgeBio Pharma's BBP-812 receives FDA RMAT designation for Canavan disease. Genprex plans to spin off its diabetes program into NewCo. NCI awards TransCode $2 million for TTX-MC138 RNA therapy in advanced solid tumors.