Biogen

Lilly’s Alzheimer’s drug Kisunla gets MHRA approval but NICE rejects it, citing lack of value for NHS.

The global digital health in neurology market is projected to grow from USD 39.82 billion in 2024 to USD 303.23 billion by 2034, driven by remote patient monitoring for long-term neurological disorders. North America dominated the market in 2023, while Asia Pacific is expected to grow the fastest. The services segment led the market in 2023, with the software segment projected to grow at the highest CAGR. Patients accounted for the largest market share in 2023, with providers expected to grow rapidly. Technological advancements, including AI and telehealth, are key growth factors.

Amgen plans to launch biosimilar Pavblu of Regeneron's Eylea 'as quickly as possible' after appeals court lifts injunction. Regeneron disappointed, vows to continue fighting, believing Amgen infringes its patent rights. Analysts surprised by Amgen's 'at risk' launch, considering potential damages.

Eisai anticipates a Q2 EU decision on Bioarctic's lecanemab, with the EMA's Scientific Advisory Board meeting in Q1 to discuss the marketing authorization application. Bioarctic and Eisai plan joint Nordic commercialization post-approval, with global collaboration involving Biogen.

The gene therapy market is rapidly expanding, with over 180 companies developing more than 200 gene therapies. Key players include Ultragenyx Pharmaceutical Inc, Rocket Pharmaceuticals, and Adverum Biotechnologies. Prominent therapies in the pipeline include DTX401, RP-L102, and ADVM-022. Gene therapy aims to treat diseases by modifying genes, offering potential long-lasting effects with fewer side effects. Challenges include immune reactions, long-term effects, and high costs.

Gene therapy clinical trials gain momentum with over 180 companies advancing treatments, leveraging technologies like CRISPR/Cas9 for precision. Key therapies include ZOLGENSMA for spinal muscular atrophy and LUXTURNA for inherited retinal diseases. Challenges include immune reactions, long-term effects, and high costs, necessitating ethical oversight and equitable access.

Roche ends partnership with UCB in Alzheimer’s disease, returning rights to Phase IIa prospect bepranemab, marking Roche’s second Alzheimer’s partnership cut this year. UCB announced the partnership termination as it prepares to present Phase IIa study results at the 2024 Clinical Trials on Alzheimer’s Disease Meeting. Roche, lagging in Alzheimer’s treatment development, continues to explore early-stage assets like RG6289 and trontinemab.

The AI in Biotechnology Market is projected to grow from USD 2.10 Bn in 2024 to USD 7.11 Bn by 2031, at a CAGR of 19%. Key opportunities include increased diagnostic accuracy, personalized therapies, revolutionized drug discovery, advanced genomic analytics, and integrated healthcare systems. Major players analyzed include AstraZeneca, Bristol-Myers Squibb, and Gilead Sciences Inc.

CROs are shifting from full-service outsourcing (FSO) to functional service provider (FSP) models driven by cost reduction, efficiency, and strategic control needs. FSP models offer specific services like clinical monitoring and data management, allowing sponsors greater control. Despite lower gross margins, FSPs provide long-term, predictable revenue streams. The shift is reshaping the CRO industry through consolidation and innovation, with FSP growth projected at over 8.68% annually.

Pharma companies are shifting from FSO to FSP models, with CROs adapting to PAOs and site networks. These networks improve trial efficiency and patient engagement, challenging CRO roles. CROs are forming alliances with PAOs and site networks, potentially evolving into 'on-site CROs' with direct site services, leveraging private equity investments in trial sites.