FDA approves Kerendia as the first new treatment for kidney disease in type 1 diabetes in decades, Novo, Roche, and Aethlon Medical strike major deals and mergers with Orbis Medicines, Dualitas Therapeutics, and North Immunology, and Thani Jambulingam of Saint Joseph's University examines the fight to control the GLP-1 patient journey.

Novo teams up with Anthropic on AI-driven drug discovery, Sling Therapeutics and Circle Pharma close major financing rounds, and IQVIA's Phil Ford makes the case for reimagining medical content as a loop rather than a pipeline.

GSK is acquiring a trispecific T-cell engager from Chimagen Biosciences and Sanofi expanding its manufacturing partnership with Cheplapharm, Stewart Gandolf discusses why pharma marketing now has to write for both people and AI, and Dr. Elena Christofides explains why cortisol dysregulation may be the hidden reason some diabetes patients fail to respond to incretin therapies.

Cellectis pivots from CAR-T to in vivo gene editing, Novo Nordisk rebrands as "Novo" to sharpen its competitive edge in obesity and diabetes care, and Wendy Short Bartie of Bristol Myers Squibb makes the case for reputation as a strategic currency.

Novartis investors intensify pressure on the company's M&A strategy after a string of trial failures, Michelle Carnahan argues health care needs an orchestration layer rather than more point solutions, and Nacho Quinones and Aisling O'Loughlin make the case for synthetic advisory boards in biopharma decision-making.

In this episode of Pricing & Policy with Model N, Jesse Mendelsohn, senior vice president at Model N, joins host Mike Christel to examine the growing stakes surrounding the 340B Drug Pricing Program — and how claims data, rebate models and legal challenges are shaping manufacturers’ response. Mendelsohn explains drugmaker concerns about overlapping discounts, the gaps in claims visibility that make them difficult to identify and the push to verify dispensing before paying a 340B rebate (all three at the heart of industry revenue leakage issues). Throughout the conversation, Mendelsohn considers what it will take to bring greater accountability and predictability to the program while preserving its underlying purpose. 00:53 - The evolution of 340B  03:39 - Understanding program's growth and impact 07:27 - Manufacturer challenges/complexities in compliance 10:43 - 340B's twisting path: Rebate pilots and more15:44 - Pharma as key stakeholder 18:25 - Claims collection hurdles 20:56 - Lilly and industry strategy shifts 23:19 - Assessing the litigation landscape 25:37 - 340B's role in pricing pie, GTN management29:20 - Fueling future debate? The two drivers

Aptar Pharma and Aceso Therapeutics team up to advance an inhaled cystic fibrosis therapy, Moonwalk Biosciences raises a $70 million Series B for its fat-targeted obesity platform, and Sebastian Arana of MilliporeSigma talks through the real cost of manufacturing flexibility.

Ionis wins FDA approval for Zanvastro, the first disease-modifying treatment for Alexander disease, Pharmaceutical Executive’s weekly biotech roundup gathers analyst reaction to the week's biggest stories, and Nate Hill of Strive Pharmacy talks through the regulatory uncertainty around compounded peptides.

Ultragenyx shares plunge after apazunersen fails its Phase III trial in Angelman syndrome, Mark Cziraky of Carelon Research talks through the mechanics of analyzing linked real-world data sets, and Melanie Whittington joins The Ron Lanton Report to argue biopharma policy needs to stay tethered to patients, not abstractions.