Support for Title 21 CFR Part 11 and Annex 11 Compliance

How early Phase I decisions can shape or compromise the regulatory and financing outcomes that define a biotech program's future.

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.