Biogen

CVS Caremark adjusts diabetes drug coverage for 2025, removing older therapies like V-go Infusion Pump and Merck's Janumet/Janumet XR, in favor of newer products and generics. Notable additions include Twiist infusion system, Zituvimet, and biosimilars to Lantus. CVS also adds HIV, cancer, and mental health treatments to its formulary.

The global biopharmaceuticals market is projected to reach USD 566 billion by 2032, driven by innovations in treating previously untreatable diseases. North America led in 2022 with a 43% share. Key players like Pfizer and InflaRx are advancing therapies, but challenges include high costs and regulatory complexities. The industry is also focusing on sustainability and digital transformation.

Sage Therapeutics' lead therapeutic asset, dalzanemdor, failed a Phase II trial for Huntington's disease, leading to discontinuation of its development. This marks the third mid-stage failure for the company, which has seen its stock value drop by over 90% in the past year and a half. Sage's pipeline is now limited, with only one commercial product, Zurzuvae, generating revenue. The company has undergone significant restructuring and layoffs to focus on Zurzuvae's commercialization, but its path to profitability remains uncertain.

The neurodegenerative disorder therapeutics market is projected to grow from $18.53 billion in 2023 to $28.33 billion in 2028 at a CAGR of 9.0%, driven by factors like aging population, rising prevalence of neurodegenerative disorders, and strategic collaborations among pharmaceutical companies.

Dapirolizumab pegol, a therapy developed by UCB and Biogen, showed significant improvement in controlling disease activity in systemic lupus erythematosus (SLE) patients in a Phase 3 trial. The therapy met its primary goal of achieving a British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) response, with 49.5% of patients on dapirolizumab pegol achieving this response compared to 34.6% on placebo. Additionally, patients experienced 50% fewer severe disease flares and were able to reduce corticosteroid doses. The therapy is generally well-tolerated, and the developers plan to further test it in a second Phase 3 trial, PHOENYCS FLY.

Cybin's CYB003, a deuterated psilocin drug for MDD, showed 12-month efficacy with 100% response rate and 71% sustained remission. The FDA's Breakthrough Therapy Designation supports its potential over existing therapies, with no new adverse events reported. Cybin plans to launch Phase 3 PARADIGM program for global efficacy and safety assessment.

The European Commission approved Samsung Bioepis' biosimilar OPUVIZ (SB15, aflibercept) for treating neovascular AMD, RVO, DME, and myopic CNV. Developed in partnership with Biogen, OPUVIZ aims to reduce treatment costs for retinal disorders, marking Samsung Bioepis' fifth biosimilar approval in Europe.

Sage Therapeutics halts development of SAGE-718 after failing mid-stage study for Huntington's disease, leaving a bare research pipeline. The company plans restructuring, including layoffs and reprioritization of early-stage projects, following setbacks with SAGE-324 and Zurzuvae. Shares have plummeted, and future profitability remains uncertain.

Lupus Therapeutics, affiliated with Lupus Research Alliance, is encouraged by the positive Phase 3 PHOENYCS GO data for dapirolizumab pegol (DZP) in treating moderate-to-severe systemic lupus erythematosus (SLE), showing significant improvement in disease activity. UCB and Biogen are initiating a second Phase 3 trial, PHOENYCS FLY, in 2024.

Biotechnology Market to grow at 13.9% CAGR from 2024-2031, driven by health, agriculture, and industrial applications. Valued at USD 1.21 Trillion in 2022, it is expected to reach USD 3.90 Trillion by 2031.