Discussing Soft Mist Inhaler Technology with Marcel Baumann (World Vaccine Conference 2023)

Made Scientific's new 85,000-sq.-ft. facility, with 145 prior GMP batches, adds clinical- to commercial-scale cell therapy capacity.

Novo Nordisk reports that CagriSema outperformed tirzepatide with 12.4% weight loss versus 9.1% in a phase 3 trial in adults with type 2 diabetes.

Vironexis Biotherapeutics reported that the first three antibody-naive patients with relapsed/refractory acute lymphoblastic leukemia treated with its one-time in vivo immunotherapy VNX-101 all achieved MRD-negative complete responses, with durability tracked through at least nine months.

Laru-zova helped 31% of high-dose patients gain 15+ letters of vision, representing the first pivotal trial to succeed in treating XLRP.

Telix will acquire ITM for $1.65 billion, gaining a phase 3-validated therapy that cut GEP-NET progression risk versus everolimus.

mAbxience and Sandoz are targeting a $5.7 billion market with a proposed emicizumab biosimilar for hemophilia A.

Fayuvi scored 23.5 points higher than untreated peers on cognitive testing, backing the first-ever approval for a Sanfilippo syndrome A gene therapy.

Panelists from FDA, Genentech, and Minaris discussed raw material risk, supplier oversight, and at-risk release strategies for advanced therapies at the PDA/FDA Joint Regulatory Conference.