Considerations and Challenges in Drug Development

FDA's new rule formally recognizes non-animal methods like organoids and AI models as valid ways to support human drug testing.

Dazodalibep hit its phase 3 primary endpoint at week 48, building on phase 2 data showing a 6.3-point ESSDAI reduction versus placebo.

Glycomine's GLM101, an investigational liposomal mannose-1-phosphate substrate replacement therapy, has received FDA Breakthrough Therapy designation for PMM2-CDG, a rare glycosylation disorder with no approved treatments.

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.