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by BioSpace
Unravel the business of science with BioSpace. We dive into biopharma's top stories and biggest challenges, whether it’s layoffs, pipeline shake-ups, acquisitions, new FDA approvals or how to regulate AI in drug development.
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- 3 days ago21 min
When vision fades: Rethinking wet AMD and the durability gap
In this episode of Denatured, you’ll hear Philip Jacob Rosenfeld, professor of Ophthalmology at the University of Miami Health System and Bascom Palmer Eye Institute, and Wesley Jackson, chief science officer at Valitor. We talk about the eye condition call wet age-related macular degeneration (AMD), the limits of anti‑VEGF therapy and the push for true durability to change a patient’s life.HostJennifer C. Smith-Parker, Director of Insights, BioSpaceGuestsPhilip Jacob Rosenfeld, Professor of Ophthalmology, University of Miami Health System, Bascom Palmer Eye InstituteWesley Jackson, Chief Science Officer, Valitor Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.
- 4 days ago22 min
FDA hears input on psychedelics, PDUFA, lung cancer’s next-gen therapies boost survival
The FDA held a public forum on Monday to discuss the future of psychedelic therapeutics, followed by a meeting on Wednesday regarding recommendations for reauthorizing the Prescription Drug User Fee Act the day after launching its TrialBlazer initiative. Meanwhile, Definium Therapeutics notched another late-stage trial win for its LSD drug, and Novartis continues to reel from the company’s triple asset stumble.
- 1 weeks ago36 min
The supply chain fault lines of modern pharma
In this episode of Denatured, sponsored by SK Pharmteco, Jennifer Smith-Parker speaks to Arvind Singh, vice president and global head of supply chain. In this episode, we discuss how CDMOs are revamping supply‑chain strategy for a new generation of intricate modalities. Topics addressed include moving from smarter raw‑material sourcing and precision cold‑chain logistics to navigating geopolitical and regulatory uncertainty and deploying AI to building sustainable, scalable capabilities from clinical through commercial.This episode is presented in partnership with SK Pharmteco. HostJennifer Smith-Parker, Director of Insights, BioSpaceGuestArvind Singh, VP & Global Head of Supply ChainDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.
- 1 weeks ago20 min
Novo’s canned heart disease trials, Novartis’ clinical fails, first approval for Alexander disease
September has been a rough month already for Novo Nordisk, which canned two more late-stage trials of its embattled IL-6 inhibitor, and Novartis, which took Phase 3 hits in both cardiovascular and muscular dystrophy indications; Ultragenyx’s big bet in Angelman syndrome failed to yield benefit in Phase 3 but Ionis’ Pharmaceuticals nabbed the first targeted approval for Alexander disease; and on the business side, biopharma investment is back in a big way.
- 2 weeks ago18 min
Breaking borders: Building biotech scale in Benelux
In this episode of Denatured, you’ll listen to Christina Takke, managing partner at V-Bio Ventures and Mariette van der Velden-Roesink, founding partner at Curie Capital. We examine why Benelux delivers world‑class science yet remains an investment patchwork, and what it will take to knit the region into a truly unified biotech investment corridor.HostJennifer C. Smith-Parker, Director of Insights, BioSpaceGuestsChristina Takke, Managing Partner, V-Bio VenturesMariette van der Velden-Roesink, Founding Partner, Curie CapitalDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.
- 2 weeks ago20 min
Novartis’ and BMS’ paused CAR T trials, RevMed’s pancreatic cancer approval, more MFN deals
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.
- 3 weeks ago19 min
Fragile X at a turning point: Breaking through the clinical bottleneck
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.HostJennifer C. Smith-Parker, Director of Insights, BioSpaceGuestsHilary Rosselot, Executive Director, National Fragile X FoundationJordi Fàbrega, Co-Founder & CEO, CONNECTA TherapeuticsDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.
- 3 weeks ago23 min
Capricor’s DMD therapy still alive, Merck/Moderna’s cancer vax shines, FDA’s future revealed
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.
About BioSpace
Unravel the business of science with BioSpace. We dive into biopharma's top stories and biggest challenges, whether it’s layoffs, pipeline shake-ups, acquisitions, new FDA approvals or how to regulate AI in drug development.
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Frequently Asked Questions
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It's a free AI-powered email that summarizes new episodes of BioSpace as soon as they're published. You get the key takeaways, notable quotes, and links & mentions — all in a quick read.
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