BioSpace

00:20:28

The race for access: How the FAIR Act could reclaim...

BioSpace ·

2026/10/01

In this episode of Denatured, you’ll hear from Max Bronstein, CEO of Aviva Strategies and Teresa Barnes, Chief Executive Warrior of PF Warriors. We dig into why U.S. patients are losing access to rare disease trials happening abroad and how the FAIR Act’s accelerated, harmonized reviews could help the U.S. keep pace while getting lifesaving studies to patients faster.Host⁠Jennifer C. Smith-Parker, Director of Insights, BioSpaceGuestsMax Bronstein, CEO, Aviva StrategiesTeresa Barnes, Chief Executive

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00:20:09

AstraZeneca buys into Summit, UniQure drops on 4-year...

BioSpace ·

2026/09/30

Summit Therapeutics scores a $2 billion equity investment from AstraZeneca to support ivonescimab’s late-stage development; uniQure crashes after four-year data from its Huntington’s disease gene therapy failed to impress; Kyverna Therapeutics brings new light to a struggling CAR T space in autoimmune disease.

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00:15:38

How radioligand therapy is rewriting cancer care

BioSpace ·

2026/09/24

In this episode of Denatured presented by Curium, Jennifer Smith-Parker speaks to Mike Patterson, CEO North America and Professor Sabine Brookman-May, vice president and head of Global Clinical Development. We examine radioligand therapy’s accelerating momentum and how its diagnostic and therapeutic reach could potentially reshape care for more than 14 million patients worldwide.We also discuss Curium's push to expand US capacity and scale up at pace, and critically what success could mean for

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00:21:21

Novo’s turnaround plan, weight loss wins,...

BioSpace ·

2026/09/23

Novo plans to hit $23B in revenue by 2035, has further reduced its workforce by 4,000 and is boosting manufacturing capacity for its Wegovy pill, but investors are unconvinced it will be enough to turn things around; Viking Therapeutics and Roche report positive results for their weight loss assets; Ultragenyx snags FDA approval for its Sanfilippo syndrome gene therapy; IPOs keep on coming.

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00:21:35

When vision fades: Rethinking wet AMD and the...

BioSpace ·

2026/09/17

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

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00:22:11

FDA hears input on psychedelics, PDUFA, lung cancer’s...

BioSpace ·

2026/09/16

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.

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00:36:20

The supply chain fault lines of modern pharma

BioSpace ·

2026/09/10

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

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00:20:19

Novo’s canned heart disease trials, Novartis’...

BioSpace ·

2026/09/09

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.

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00:18:34

Breaking borders: Building biotech scale in Benelux

BioSpace ·

2026/09/03

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,

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00:20:23

Novartis’ and BMS’ paused CAR T trials, RevMed’s...

BioSpace ·

2026/09/02

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.

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00:19:23

Fragile X at a turning point: Breaking through the...

BioSpace ·

2026/08/27

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

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00:23:27

Capricor’s DMD therapy still alive, Merck/Moderna’s...

BioSpace ·

2026/08/26

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.

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00:19:39

Rewriting the rules of CMV prevention

BioSpace ·

2026/08/20

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.HostJennifer C. Smith-Parker, Director of Insights, BioSpaceGuestsIan McGowan, CMO, SynklinoJames Hunter, Associate Professor of Transplantation, Oxford

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00:19:08

Amylyx’s redemption story, Summit’s survival woes,...

BioSpace ·

2026/08/19

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.

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00:18:54

The Italian inflection point: Clinical strength,...

BioSpace ·

2026/08/13

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.HostJennifer C. Smith-Parker, Director of Insights, BioSpaceGuestsDiana Saraceni, Founder and

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00:19:01

Replimune finally wins approval, Q2 earnings wrap up,...

BioSpace ·

2026/08/12

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.

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00:23:14

Rumors of biggest pharma merger ever drop amid Q2...

BioSpace ·

2026/08/11

The industry has been abuzz since the weekend when talks of a potential mega-merger between Bristol Myers Squibb and AstraZeneca were reported. Meanwhile, Pfizer, Merck and others release second quarter earnings, with some disclosing pipeline discontinuations and cost-cutting measures. Finally, all eyes turn to the FDA in the wake of heated advisory committee meetings for Capricor Therapeutics and Replimune.

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00:20:18

The next treatment-resistant depression paradigm

BioSpace ·

2026/08/06

In this episode of Denatured, you’ll hear from Hans Eriksson, chief medical officer at FundaMental Pharma and Steve Levine, chief patient officer at Compass Pathways. We explore why treatment-resistant depression remains so difficult to address, and how new approaches—from rapid-acting antidepressants to psychedelic therapy—may reshape the treatment paradigm.Host⁠Jennifer C. Smith-Parker, Director of Insights, BioSpaceGuestsHans Eriksson, Chief Medical Officer, FundaMental PharmaSteve Levine, Chief

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00:24:42

Rumors of biggest pharma merger ever drop amid Q2...

BioSpace ·

2026/08/05

The industry has been abuzz since the weekend when talks of a potential mega-merger between Bristol Myers Squibb and AstraZeneca were reported. Meanwhile, Pfizer, Merck and others release second quarter earnings, with some disclosing pipeline discontinuations and cost-cutting measures. Finally, all eyes turn to the FDA in the wake of heated advisory committee meetings for Capricor Therapeutics and Replimune.

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00:24:01

Life after the lead asset: Advancing an early-stage...

BioSpace ·

2026/07/30

In this episode of Denatured presented by Arvinas, Jennifer Smith-Parker speaks to Arvinas President and CEO Randy Teel about the strategic discipline and leadership required to successfully refocus a company on an early-stage pipeline after a lead asset is outlicensed, discontinued or otherwise falls away — an inflection point many biotech and pharma companies face, but few navigate effectively.This episode is presented in partnership with Arvinas. HostJennifer Smith-Parker, Director of Insights,

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