BioSpace

Novartis hits pause on several CAR T trials after three patient deaths, followed by Bristol Myers Squibb after separate safety signals; Revolution Medicines scores early FDA approval for groundbreaking pancreatic cancer drug; BioNTech suspends a mid-stage trial of its mRNA cancer immunotherapy after a futility analysis; and nine mid-sized biopharma companies join their big pharma peers in President Donald Trump’s Most Favored Nation drug pricing scheme.

In this episode of Denatured, you’ll hear from Hilary Rosselot, executive director at the National Fragile X Foundation and Jordi Fàbrega, co-founder & CEO at CONNECTA Therapeutics. From trial endpoints and placebo effects to neuroplasticity modulation, we explore what it will take to build a sustainable path to the first approved therapy.

Host
Jennifer C. Smith-Parker, Director of Insights, BioSpace

Guests
Hilary Rosselot, Executive Director, National Fragile X Foundation
Jordi Fàbrega, Co-Founder & CEO, CONNECTA Therapeutics

Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

FDA extends its review of Capricor Therapeutics’ Duchenne muscular dystrophy cell therapy as an unhappy shareholder advocates for change; Merck and Moderna tout positive data for their mRNA-based cancer vaccine; Trump nominates White House aide Heidi Overton as FDA commissioner; and the oral obesity market heats up with rivals Eli Lilly and Novo Nordisk going head-to-head.

In this episode of Denatured, you’ll hear from Ian McGowan, Chief Medical Officer at Synklino and James Hunter, associate professor of transplantation at Oxford University. We explore transplantation and antiviral innovation and why CMV remains one of the most persistent and consequential challenges facing transplant patients today.

Host
Jennifer C. Smith-Parker, Director of Insights, BioSpace

Guests
Ian McGowan, CMO, Synklino
James Hunter, Associate Professor of Transplantation, Oxford University

Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.
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Amylyx shares good news for its investigational GLP-1 blocker; Definium announces positive data for its LSD-based therapy in anxiety; Summit/Akeso’s ivonescimab shows degrading survival benefits; patients treated with Neurocrine’s Prader-Willi drug experience serious adverse events; and Eli Lilly cracks down on the black market for next-gen obesity asset retatrutide.