Biogen

Drug development is lengthy, costly, and complex, typically taking 14 years and $1-2 billion. The process involves discovery, pre-clinical testing, and clinical trials (Phases 1-3), followed by FDA approval and Phase 4 monitoring. Key challenges include limited diverse genetic data, slow vendor selection, site saturation, patient recruitment, and data accuracy. Digital innovations aim to streamline these processes, accelerating therapy delivery.

DelveInsight's 'Graft versus host disease Pipeline Insight 2024' covers 60+ companies and 65+ pipeline drugs, including clinical and nonclinical stage products, with a focus on therapeutics assessment by product type, stage, route of administration, and molecule type. Key companies and promising therapies in development are highlighted.

Eisai launched Leqembi in South Korea for mild cognitive impairment due to Alzheimer’s disease or mild AD dementia. Leqembi selectively binds to amyloid-beta aggregates, reducing disease progression and cognitive decline. Developed by BioArctic and Eisai, it is approved in multiple countries and under review in others. BioArctic and Eisai are preparing for joint commercialization in the Nordic region.

Mirikizumab (Omvoh) showed improved outcomes in Crohn's disease patients with previous standard therapy failure, with 38% meeting composite endpoint of PRO clinical response at week 12 and endoscopic response at week 52 vs. 9% on placebo (P<0.0001). Mirikizumab also met primary endpoint of PRO clinical response at week 12 and CDAI clinical remission at week 52 in 45.4% vs. 19.6% on placebo (P<0.0001). The study highlights IL-23's role in Crohn's disease pathogenesis and suggests mirikizumab's favorable benefit-risk profile.

The biotech sector is advancing with AI, gene editing, precision medicine, and biomanufacturing, driving drug development and treatment options. Key stocks like Amgen Inc. (AMGN), Gilead Sciences (GILD), and Biogen Inc. (BIIB) are capitalizing on these trends, focusing on oncology, neurological disorders, and infectious diseases. The global biotechnology market is expected to grow at a CAGR of 11.5% to $4.61 billion by 2033. AMGN, BIIB, and GILD are highlighted for their innovations, financial performance, and market prospects.

Propionic acid deficiency may contribute to multiple sclerosis (MS) pathology. Propionate shows beneficial effects on immune, peripheral, and central nervous systems in MS patients, potentially improving outcomes when used with immune-modulating therapy. Further large clinical trials are necessary to evaluate its efficacy and safety.

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Eisai and Biogen launch LEQEMBI, a humanized anti-amyloid-beta monoclonal antibody, in South Korea for treating Alzheimer's disease, targeting soluble and insoluble Abeta aggregates to reduce cognitive decline.

Eisai and Biogen launch Leqembi in South Korea for mild cognitive impairment or early Alzheimer’s disease.

Eisai and Biogen launch LEQEMBI, a humanized anti-soluble aggregated amyloid-beta monoclonal antibody, in South Korea for treating mild cognitive impairment due to Alzheimer's disease or mild AD dementia. LEQEMBI selectively binds to soluble and insoluble Aβ aggregates, reducing both protofibrils and plaques in the brain, and is the first treatment shown to slow cognitive and functional decline through this mechanism.