Latest Content

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.

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.