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Novo Nordisk reports positive phase 3 CagriSema data, Biocon’s pertuzumab biosimilar gets a positive CHMP opinion under EMA’s new tailored pathway, and Vironexis reports complete responses with its one-time in vivo therapy for relapsed ALL.

Eron Kelly, CEO of ConcertAI, and Dr. Shaalan Beg, CMO, oncology, ConcertAI, discuss how AI can help physicians access the right information at the right time while supporting clinical trials, research, and quality initiatives.

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

Biocon's Pebrilzo, a pertuzumab biosimilar for HER2-positive breast cancer, has become the first monoclonal antibody biosimilar to receive a positive CHMP opinion under EMA's newly adopted tailored clinical approach, which can reduce comparative efficacy trial requirements.

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.

New data show risk-based and centralized monitoring shifts effort across roles, sites, and timelines, reshaping how sponsors plan CRA capacity needs.

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.

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

Athenecia Faggins of Minaris Advanced Therapies discusses raw material qualification, supplier management, testing, and risk control for advanced therapy manufacturing.

FDA compliance officers detailed 2026 guidance updates, online drug sale enforcement, and a first-of-its-kind AI-related warning letter at the PDA/FDA Joint Regulatory Conference.

Sanofi’s Jack Prior discusses how biopharmaceutical manufacturers can assess whether process data is ready for human and AI use, and the role of data quality, accessibility, governance, and AI in manufacturing.