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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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35 episodes
Avg 21 min
English

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Thursday · 21 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. Host Jennifer C. Smith-Parker, Director of Insights, BioSpace Guests Philip Jacob Rosenfeld, Professor of Ophthalmology, University of Miami Health System, Bascom Palmer Eye Institute Wesley 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.
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Wednesday · 22 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.
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September 10 · 36 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. Host Jennifer Smith-Parker, Director of Insights, BioSpace Guest Arvind Singh, VP & Global Head of Supply Chain Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.
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September 9 · 20 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.
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September 3 · 18 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. Host ⁠Jennifer C. Smith-Parker, Director of Insights, BioSpace Guests Christina Takke, Managing Partner, V-Bio Ventures Mariette van der Velden-Roesink, Founding Partner, Curie Capital Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.
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September 2 · 20 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.
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August 27 · 19 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. 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.
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August 26 · 23 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.
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August 20 · 19 min
Rewriting the rules of CMV prevention
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. Custom Fields
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August 19 · 19 min
Amylyx’s redemption story, Summit’s survival woes, Definium’s anxiety win, more
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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August 13 · 18 min
The Italian inflection point: Clinical strength, culture and capital
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.
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August 12 · 19 min
Replimune finally wins approval, Q2 earnings wrap up, psychedelics stay in spotlight
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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August 11 · 23 min
Rumors of biggest pharma merger ever drop amid Q2 earnings, contentious FDA adcomms
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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August 6 · 20 min
The next treatment-resistant depression paradigm
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. Host ⁠Jennifer C. Smith-Parker, Director of Insights, BioSpace Guests Hans Eriksson, Chief Medical Officer, FundaMental Pharma Steve Levine, Chief Patient Officer, Compass Pathways Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.
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August 5 · 24 min
Rumors of biggest pharma merger ever drop amid Q2 earnings, contentious FDA adcomms
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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July 30 · 24 min
Life after the lead asset: Advancing an early-stage pipeline
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. Host Jennifer Smith-Parker, Director of Insights, BioSpace Guest Randy Teel, President and CEO, Arvinas
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July 29 · 17 min
Capricor and Replimune prep for FDA adcomms, Q2 earnings roll on, Sarepta’s new leader, more
The FDA published briefing documents ahead of advisory committee meetings for Capricor Therapeutics’ Duchenne muscular dystrophy therapy and Replimune’s advanced melanoma drug indicating an uphill battle for the biotechs; GSK and AstraZeneca outlined ambitious plans in second quarter presentations; Sarepta tapped Michael Severino as its new CEO; and Amgen launched its official defense of Tavneos.
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July 23 · 20 min
Nordic biotech’s next act: From fragmentation to global force
In this episode of Denatured, you’ll hear from Ester Sklarsky, principal at Sound Bioventures and João Ribas, partner at Novo Holdings Seed Investments. In this episode, we explore the diverging trajectories of Nordic biotech and what it will take for the region, including Norway and Finland, to compete more cohesively on the global stage. Host Jennifer C. Smith-Parker, Director of Insights, BioSpace Guests Ester Sklarsky, Principal, Sound Bioventures João Ribas, Partner, Novo Holdings Seed Investments Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.
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July 22 · 21 min
Q2 earnings underway, FDA’s CRL kerfuffle, IPOs full speed ahead in H2
Second quarter earnings continue to roll with Novartis and Roche reporting this week; Eli Lilly’s AtaiBeckley buy for up to $3.8 billion offers clear “validation” for the fledgling psychedelics space; more drama unfolds at FDA as the agency goes back and forth on its policy of publishing complete response letters in real-time; and IPO fever continues.
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July 16 · 19 min
The future of pain relief: Exploring opioid alternatives
In this episode of Denatured, you’ll hear from Lance Alstodt, chairman and CEO at Biorestorative Therapies, and Paul Mieyal, chief business officer at South Rampart Pharma. We explore why pain has remained such a difficult therapeutic area to tackle and one of the biggest unmet needs today, and how non-opioid mechanisms to regenerative therapies could reshape the future of treatment. Host Jennifer C. Smith-Parker, Director of Insights, BioSpace Guests Lance Alstodt, Chairman & CEO, BioRestorative Therapies Paul Mieyal, Chief Business Officer, South Rampart Pharma Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.
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Showing 1–20 of 35 episodes