Pharmaceutical Executive

FDA approves Ultragenyx's Fayuvi as the first treatment for Sanfilippo syndrome type A, Lisata Therapeutics acquires Marea Therapeutics as mAbxience partners with Sandoz on a hemophilia A biosimilar, and Joe Cunningham argues that executive drug-pricing deals alone won't fix costs.

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 more 15:44 - 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 management 29:20 - 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.

Melanie Whittington, managing director and head of the Leerink Center for Pharmacoeconomics, joins Ron Lanton to argue that biopharmaceutical policy only makes sense when traced back to its purpose.

Novartis and Bristol Myers Squibb pause autoimmune CAR-T trials over safety concerns, a dealmaking roundup covers Alteogen's licensing deal with Novartis, NewBiologix's gene therapy partnership with Synastra, and RedHill's acquisition of Rebyota and Clenpiq from Ferring, and Lexi Cogswell and Tom Rotolo make the case for real-world insights in obesity medical strategy.

The Trump administration adds nine drugmakers to its Most Favored Nation pricing program, GSK advances its dual-antigen mRNA flu vaccine into Phase III, and Simcere Zaiming licenses its tri-specific antibody Sim0660 to Roche for up to $1.53 billion.

Eli Lilly agrees to acquire Merida Biosciences for up to $2.875 billion, BioNTech halts a Phase II trial of its cancer immunotherapy Cevumeran, and Parth Khanna argues that more competitive data doesn't mean better intelligence in pharma.

FDA approves three new therapies spanning autoimmune disease, HIV, and cardiovascular risk, DualityBio and Teva strike major biopharma deals, and Israel Ortiz makes the case for preventive maintenance in manufacturing.

Osivax and GC Biopharma team up on a next-generation flu vaccine, K2 Therapeutics' Ying Huang talks through why so few drugs make it to market, and the Trump administration opens a new round of Medicaid drug pricing deals.

A new Eli Lilly study links Zepbound to lower healthcare costs in older adults with obesity, Biohaven and Haisco strike major licensing deals with SK Biopharmaceuticals and Sentivera, and Raviv Pryluk makes the case for rethinking clinical trial sample sizing.

FDA approves Imaavy as the first treatment for warm autoimmune hemolytic anemia, McKesson agrees to acquire Precision Medicine Group as Lundbeck partners with Eversana on AI-driven commercialization, and Adam Bartley examines how integrated GMP operating models are reshaping outsourced manufacturing.

Hanmi Pharm licenses its obesity drug candidate HM17321 to Genentech, James LaValle weighs in after FDA advisors back most nominated peptides for the compounding bulks list, and Ivo Carre examines how tau- and microglia-targeted therapies are reshaping the Alzheimer's pipeline beyond amyloid.