NOVARTIS

Curocell appoints Lee Seung-won as managing director to lead domestic commercialization of next-gen CAR-T treatment CRC01 (Anbal-cel). Lee, with 20+ years in hematologic cancers and CAR-T therapeutics, aims to expedite Anbal-cel's approval and global expansion.

Mereo BioPharma's Q3 2024 report shows no revenue, $9.4M operating loss, and $15M net loss. Focus on rare disease therapeutics with setrusumab and alvelestat in development. Expects significant operating losses and needs additional funding for R&D and potential commercialization.

The FDA's approval of the first CRISPR therapeutic, Casgevy, marks a milestone in gene-editing therapies, with over 300 CRISPR-based treatments in development. Innovations in drug-delivery vectors, such as nonviral options like lipid nanoparticles (LNPs), polymer-based nanoparticles, and extracellular vesicles (EVs), are crucial for enhancing specificity, efficiency, and safety. These advancements could reduce healthcare costs and improve patient access, potentially leading to cures for chronic diseases. Flow cytometry and analytical ultracentrifugation are key tools in vector development, aiding in the characterization and optimization of these delivery systems.

The Nasal Drug Delivery Technology Market is projected to grow from USD 4.4 billion in 2024 to USD 7.8 billion by 2031, driven by non-invasive drug administration, technological advancements, and rising respiratory disease prevalence.

Novartis presented NVP-IWY357, a novel antimalarial with no cross-resistance to current drugs and potential for single-dose cure, at ACS Fall 2024 conference in Denver.

Biopharma layoffs continue into 4Q 2024, affecting companies like Thermo Fisher, Charles River, Pfizer, Evonik, Johnson & Johnson, Bayer, Bristol Myers Squibb, AGC Biologics, and others. These layoffs are part of restructuring initiatives, site closures, and focus shifts in strategic core growth areas.

Google DeepMind releases AlphaFold 3 for academic use, predicting protein structures 50% more accurately. Linked to Isomorphic Labs aiming to revolutionize drug discovery, it has formed partnerships with Eli Lilly & Co. and Novartis AG. Google DeepMind, in collaboration with Isomorphic Labs, has predicted over 200 million protein structures using AlphaFold and introduced AlphaProteo for novel protein generation.

FDA approves Autolus Therapeutics' Aucatzyl, a CAR-T therapy for relapsed/refractory B-cell acute lymphoblastic leukemia, priced at $525,000, 11% higher than Gilead's Tecartus. Aucatzyl aims to reduce side effects and is the first CAR-T approved without a risk mitigation plan, with 63% complete remission rate in clinical trial.

Liposarcoma, a common subtype of soft tissue sarcoma, includes dedifferentiated liposarcoma (DDLPS) with high MDM2 amplification. Brigimadlin, an MDM2-p53 antagonist, showed stable disease in 75% of patients in a phase 1a/1b study. A phase 2/3 Brightline-1 trial compares brigimadlin to doxorubicin in advanced DDLPS, aiming to identify optimal dosing and assess progression-free survival.

The global biotechnology market is projected to reach $550.83 billion in 2024 and $2667.36 billion by 2034, driven by advancements in synthetic biology, CRISPR, and genomic sequencing. North America is expected to lead, with a revenue of $231.68 billion in 2024, due to established agricultural biotechnology and a robust GMO framework. Key players include Johnson & Johnson, Roche, Pfizer, and Novartis.