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Model N's Jesse Mendelsohn examines the growing stakes surrounding the 340B Drug Pricing Program — and how claims data, rebate models and simmering legal challenges are influencing manufacturer response and strategy today.

HHS confirms permanent directors for CDER and CBER and creates FDA's first-ever Deputy Commissioner for Technology and AI.

Dr. Elena Christofides on why cortisol dysregulation may explain why so many patients fail to respond to GLP-1 and incretin therapies.

Back Bay’s director discusses why IBD remains underserved — JAK inhibitor constraints, emerging oral mechanisms, and the durability gap.

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.

Aptar Pharma and Aceso Therapeutics have partnered to advance ACT-101, an antisense oligonucleotide targeting the underlying mechanisms of cystic fibrosis.

Moonwalk Biosciences has closed a $70 million Series B to advance its adipose-targeted RNAi platform toward first-in-human studies.

Sebastian Arana, head of process solutions at MilliporeSigma, discusses the operational tradeoffs facilities face as they move toward multi-modality production and the persistent cost and scale-up challenges shaping cell and gene therapy, mRNA, and ADC manufacturing.

Back Bay’s director discusses why IBD remains underserved — JAK inhibitor constraints, emerging oral mechanisms, and the durability gap.

Carelon Research's Mark Cziraky on why analyzing RWD in place — rather than licensing it out — is reshaping how evidence gets generated.

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.

FDA has approved Ionis Pharmaceuticals' Zanvastro (zilganersen) as the first disease-modifying treatment for Alexander disease.

CAR-T safety halts, a rare disease trial failure, a China licensing deal, an mRNA flu vaccine advance, and nine new MFN agreements.

Christian Tinel on why Rinvoq succeeds in IBD despite safety concerns — and what a cleaner oral alternative would mean for the market.

Nate Hill, co-founder & CEO, Strive Pharmacy, breaks down looming questions around the completed FDA PCAC hearing on 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.

Ultragenyx shares plunge more than 40% after apazunersen fails to meet both endpoints in a Phase III trial for Angelman syndrome.

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.

Carelon Research's Mark Cziraky on why trusted research environments don't change how analysis is done — just how fast and richly it can begin.

Christian Thienel on why IBD's unmet need comes down to one thing: an oral therapy with biologic-like efficacy and better safety.

Nate Hill, co-founder & CEO, Strive, notes the key milestone to watch for during the remaining step in FDA's formal Category one announcement for peptides.

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.

Novartis suspends eight autoimmune trials of its CAR-T therapy Rap-cel after three cases of fatal outcomes, while Bristol Myers Squibb voluntarily pauses enrollment in its Zola-cel autoimmune studies over transient inflammatory events.

Alteogen grants Novartis options to develop subcutaneous formulations using its ALT-B4 hyaluronidase platform, NewBiologix and Synastra partner to develop a stable producer cell line, and RedHill acquires global commercialization rights to Ferring's Rebyota and Clenpiq.

Real-world evidence tells you what happened. Real-World iNSIGHTS tell you why — and what to do next. A new framework for medical affairs.

Nate Hill, co-founder & CEO, Strive, explains how Strive is managing peptide uncertainty by pre-sourcing API, running stability and testing, and working with legal counsel to calibrate risk.

Carelon Research's Mark Cziraky on why bringing compute to data — not moving data — reduces risk and accelerates real-world evidence generation.

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.