BioSpace

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.

In this episode of Denatured, you’ll hear from Diana Saraceni, founder and managing partner at Panakès Partners and Fabrizio Calisti, medical director at Angelini Ventures. We explore how Italy’s life sciences ecosystem has evolved over the last decade—from stronger tech transfer and growing venture capital to the gaps that still keep it from matching the UK, Germany or France in company creation and scale.

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

Guests
Diana Saraceni, Founder and Managing Partner, Panakès Partners
Fabrizio Calisti, Medical Director, Angelini Ventures

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

After two rejections, Replimune has made it across the regulatory finish line with its twice-rejected therapy for advanced melanoma. Meanwhile, the last of the major pharmas, including Eli Lilly and Novo Nordisk, reported second quarter earnings, and psychedelics made headlines once again.