ScienceLife Sciences

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.

Play

Open in

50 episodes
Avg 20 min
English

Episodes 50

Newest Oldest Longest

All20 Unplayed20 In progress0 Played0

Counted on this page — what you have heard stays on this device, so it is not something the list can be paged by.

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.
- Transcript
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.
- Transcript
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.
- Transcript
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
- Transcript
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.
- Transcript
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.
- Transcript
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.
- Transcript
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.
- Transcript
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.
- Transcript
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.
- Transcript
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
- Transcript
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.
- Transcript
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.
- Transcript
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.
- Transcript
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.
- Transcript
July 15 · 21 min
Biogen validates anti-tau approach at AAIC, psychedelics full speed ahead, ATTR-CM shakeup
Biogen’s new data, presented at the Alzheimer's Association International Conference, supports a tau-focused approach to the intractable neurodegenerative disease; psychedelics are back in the news with more positive data from Compass Pathways and final guidance from the FDA; and the ATTR-CM space got a major shakeup with the late-stage failure of AstraZeneca and Ionis’ antisense therapeutic.
- Transcript
July 14 · 9 min
Bonus: Q2 2026 Job Market Update
In this bonus episode, BioSpace Managing Editor Jef Akst and Angela Gabriel, content manager, life sciences careers, look at the Q2 job market and discuss encouraging signs for job seekers.
- Transcript
July 10 · 20 min
From sequence to scale: Gene editing’s new era in biologics manufacturing
In this episode of Denatured, you’ll hear from Jack Crawford, CEO of Demetra, and Magnus Gustavsson, chief commercial officer at NorthX Biologics. We unpack the evolution of cell line development — CHO cells, targeted integration, transposases and the collaboration models speeding biologics from sequence to GMP. Host Jennifer C. Smith-Parker, Director of Insights, BioSpace Guests Jack Crawford, CEO, Demeetra Magnus Gustafsson, Chief Commercial Officer, NorthX Biologics Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.
- Transcript
July 8 · 17 min
Vertex carries M&A uptick into H2, IPOs and VC raises also grow, FDA on pace despite turmoil
A surprising deal from Vertex Pharmaceuticals adds to Big Pharma’s acquisitive streak as Crinetics folds into the cystic fibrosis drugmaker. Meanwhile, IPOs and venture capital raises trend upward, but mostly for derisked companies. Plus, FDA decisions slow only slightly as the hunt for a permanent leader drags on.
- Transcript
July 1 · 22 min
Sentiment at BIO soars as FDA resets, dealmaking evolves; Amgen’s Tavneos in hot water
The vibe at BIO 2026 in San Diego last week was overwhelmingly positive, with attendees observing noticeable changes at the FDA and an uptick in dealmaking and IPOs. Plus, a top medical journal this week retracted a pivotal study for Amgen’s rare disease drug Tavneos, which has been in the FDA’s crosshairs since January.
- Transcript

Showing 21–40 of 50 episodes