Immunological
The Paris-headquartered giant has put the spotlight on its extensive investments at home.
Following US approval of its first-in-class drug for IgAN sibeprelimab, Otsuka is planning an sNDA for an autoinjector in 2026 and is in talks with regulatory authorities in Japan and Europe.
The growth of China’s biopharma sector has been perhaps the most significant sector trend this year – Scrip outlines five themes that have emerged during 2025 and in discussions at the recent Jefferies conference in London.
Deal Snapshot: The biotech is joining forces with the Versant Ventures-backed startup, paying $50m upfront to apply its macrocycle peptide platform to immunological diseases.
Byterna, Starna, Vivacta and DeliNova ride surging investor sentiment on in vivo CAR-T assets to secure venture funding.
The biopharma plans to advance the PD-1 agonist in rheumatoid arthritis despite its failure in ulcerative colitis.
In a world-first, Beijing Mabworks has scored a Phase III clinical win for its novel anti-CD20 antibody in the treatment of primary membranous nephropathy. However, multiple global contenders including Roche are threatening to come from behind in the race.
A late-stage win in the ALLEGORY study in SLE supports Roche’s push to expand Gazyva beyond oncology and into autoimmune diseases.
The Swiss major plans to submit the positive results from the NEPTUNUS program to health authorities globally in early 2026.
The departing CEO announced improved full-year sales and profit forecasts before handing over to Luke Miels in January; he will then have to deliver on GSK’s upgraded forecast of £40bn revenues in 2031.
With a novel mechanism of action that potentially improves tolerability and retreatment flexibility, and now armed with promising Phase II data, Zenas could be set to take on some massive competition.
Biogen will pay Vanqua $70m up front for global rights to preclinical VQ-201, a potential competitor to Amgen’s C5aR antagonist Tavneos in immunological conditions.
Dupixent revenues were a record €4.16bn but the “negative buzz around vaccines” is hurting flu sales, according to chief financial officer François Roger.
With a mechanism better known for its use in breast cancer, Elevara believes its CDK4/6 inhibitor candidate could help more patients with rheumatoid arthritis reach complete remission.
Bharat Serums showed it’s possible to score a regulatory win with real-world evidence (RWE) studies in India when it ran one leading to a label expansion for its mAb trinbelimab. As cell and gene therapies and rare disease drugs gain currency, sponsors could look at takeaways from the RhYTHM study.
Seeking to compete with GSK’s Benlysta, the Roche unit obtains the first FDA approval of an anti-CD20 agent in lupus nephritis, a complication of lupus that can lead to end-stage kidney disease.
Multiple Chinese biopharma firms reach new deals with major Western and other partners in a spree of licensing deals over a one-day period, with ADCs, in vivo CAR and bifunctional fusion protein therapies among the target assets.
Following Pfizer and AstraZeneca’s US drug-pricing deals with the Trump Administration, the CEO said J&J continually has sought common ground with the White House.
More deals could be on the way as the US giant is rumored to be eyeing the acquisition of its icotrokinra development partner.
The drugmaker is joining the rush to acquire an in vivo CAR-T therapy developer as concerns mount about whether the health care system can accommodate cell therapies’ dramatic growth.