Biogen

UCB and Biogen announce positive Phase 3 PHOENYCS GO study results for dapirolizumab pegol in moderate-to-severe systemic lupus erythematosus (SLE), meeting primary endpoint with greater improvement in disease activity after 48 weeks compared to placebo.

UCB and Biogen's lupus drug met primary endpoint in Phase III PHOENYCS GO trial, showing greater improvement in moderate-to-severe SLE activity. The drug also improved secondary endpoints and maintained a consistent safety profile. UCB's stock rose 2.57% post-announcement. A new Phase III trial, PHOENYCS FLY, will start before year-end.

Biogen and UCB report positive late-stage trial results for experimental lupus drug dapirolizumab pegol, planning a second Phase 3 trial. The drug showed significant improvement over placebo when combined with standard care, with detailed results to be presented at a medical meeting. This could lead to a new therapy for systemic lupus erythematosus (SLE), a challenging autoimmune disease with limited treatment options.

UCB and Biogen report positive Phase 3 PHOENYCS GO study results for dapirolizumab pegol in treating moderate-to-severe systemic lupus erythematosus (SLE), meeting primary endpoint of improved disease activity after 48 weeks. The safety profile aligns with previous studies, and a second Phase 3 trial, PHOENYCS FLY, is planned for 2024.

Samsung Bioepis received a positive scientific opinion from the EMA’s CHMP for Opuviz (SB15), a biosimilar referencing Eylea, after reviewing its MAA. A positive CHMP opinion typically leads to EC approval within 2-3 months. Opuviz targets ophthalmic diseases like wet AMD, inhibiting VEGF to prevent new blood vessel formation. Biogen, Samsung Bioepis’ partner, will manage European marketing and distribution post-approval.

Biogen CEO Chris Viehbacher praises PM Modi's vision of making India central to 21st-century tech progress, highlighting India's talented, youthful population. Viehbacher emphasizes technology's role in inclusive healthcare and India's potential as a global tech hub, aligning with Modi's focus on societal benefits from tech advancements.

Biogen CEO Chris Viehbacher supports PM Modi's vision of India as a tech leader, emphasizing the importance of inclusive technology for better healthcare, leveraging India's talented and youthful population.

Samsung Bioepis and Biogen announce EMA's CHMP positive opinion for Opuviz, a biosimilar referencing Eylea, recommended for approval in adult patients for treating neovascular AMD, RVO, DME, and myopic CNV. The CHMP's decision is based on clinical data showing equivalent efficacy and comparable safety profiles between Opuviz and reference aflibercept. The positive opinion will be referred to the EC for a marketing authorization decision.

PM Modi held a 'fruitful' roundtable with US tech CEOs in NY, discussing AI, quantum, biotech, computing, and semiconductors. He emphasized India's growth prospects, IP protection, and fostering tech innovation, aiming to make India a global hub for semiconductor manufacturing and a biotech powerhouse.

OpenAI's ChatGPT release in 2022 boosted AI euphoria, benefiting Nvidia. Eli Lilly, the 'Nvidia of the GLP-1 and weight loss space,' is poised for growth with its GLP-1 medicines, Mounjaro and Zepbound, and its Alzheimer's candidate, donanemab. Lilly's partnership with OpenAI aims to leverage generative AI for healthcare breakthroughs.