Gaining full rights to a bispecific antibody to treat atopic dermatitis, Johnson & Johnson is paying $1.25 billion to acquire Yellow Jersey Therapeutics, a wholly owned subsidiary of Numab Therapeutics AG. The subsidiary houses all assets related to NM-26, which targets IL-4Ra (type I and II receptors) and IL-31, and was designed with Numab’s MATCH (Multispecific Antibody-based Therapeutics by Cognate Heterodimerization) technology platform. It is ready for phase II development for atopic dermatitis, although J&J intends to develop, manufacture and commercialize the drug globally for follow-on indications as well. Read More
Japanese industrial conglomerate Asahi Kasei Corp. has made an offer to acquire Swedish rare diseases specialist Calliditas Therapeutics AB for SEK11.8 billion (US$1.1 billion). The offer, at an 83% premium to the closing share price of SEK113.60 on Monday, May 27, is recommended by the three biggest shareholders and the board of Calliditas, which said the company would benefit from “being part of a larger platform.” Read More
Insmed Inc.’s phase III study of brensocatib in treating noncystic fibrosis bronchiectasis hit its primary and multiple secondary endpoints, impressing investors with statistically significant results. The positive data could lead to the first drug approval for the treating the deadly lung disease. Read More
Innovent Biologics Inc.’s picankibart (IBI-112) met all primary endpoints and key secondary endpoints in the phase III registrational Clear-1 trial in Chinese subjects with moderate to severe plaque psoriasis. Read More
Treatment with indoleamine dioxygenase-1 (IDO1) inhibitors reduced both viremia and B cell transformation in animal models of post-transplant lymphoproliferative disorder (PTLD), while IDO1 up-regulation occurred in patients who would go on to develop PTLD. The findings, which were reported in the May 24, 2024, issue of Science by researchers from the University of Basel and the University Hospital Basel, point to new ways to predict, prevent and treat complications of Epstein-Barr virus (EBV) infection. Read More
A recent hearing in the U.S. House of Representatives highlighted some of the issues Congress has with the agency’s performance, but there were questions as well about the FDA’s statutory authorities. One of these is the lack of statutory authority to require a recall for prescription drugs as well as the deadline for notifying the agency of device recalls, both of which are areas of legislative interest on the part of Congress. Read More
Vorasidenib, a glioma candidate under U.S. FDA review, may bring in additional cash for Agios Pharmaceuticals Inc., this time via a deal with Royalty Pharma, which agreed to pay $905 million to Agios in exchange for the 15% royalty arrangement stemming from an earlier collaboration with Servier Pharmaceuticals LLC. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alligator, Cogent, Coherus, Cullinan, Elicio, I-Mab, Iovance, Sensei, Supernus, Tyligand, Zealand. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Henlius, Organon, Summit, Verastem. Read More
