The decisions behind scientific progress

Novartis confirms that nine patients treated with its spinal muscular atrophy gene therapy Zolgensma have developed tumors; the FDA orders GLP-1 drugmakers to add a warning to their labels about the risk of a rare eye condition that can lead to vision loss; and the agency is set to decide on no fewer than 11 therapies this month, including closely watched applications from Summit Therapeutics, Vertex and Capricor Therapeutics.

In this episode of Denatured, you’ll hear from Lewis Bender, CEO at Intensity Therapeutics and Paul-Peter Tak, president, CEO and board director at Candel Therapeutics. We explore how intratumoral therapies trigger systemic anti-cancer immunity from a local injection, and redefine a foundational platform in immuno-oncology.HostJennifer C. Smith-Parker, Director of Insights, BioSpaceGuestsLewis Bender, President & CEO, Intensity TherapeuticsPaul-Peter Tak, President, CEO and Board Director, Candel TherapeuticsDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

The majority of the large pharmas have now reported third quarter earnings—spoiler alert: Eli Lilly made more money than anyone expected. Plus, the FDA dropped another initiative aimed at accelerating rare disease treatments; HHS greenlights the compounding of six unapproved peptides; and uniQure’s embattled gene therapy for Huntington’s disease has finally been accepted for review.

In this episode of Denatured, you’ll hear from Jerome Barley, commercial director at Avion Medical and Ryan Klein, vice president, business development, US and APAC at Resolian. We discuss why Australia has become a magnet for early clinical development, and whether its speed, regulatory clarity and tax incentives are pushing it toward a more integrated biotech role.HostJennifer C. Smith-Parker, Director of Insights, BioSpaceGuestsJerome Barley, Commercial Director, Avion MedicalRyan Klein, Vice President, Business Development, US and APAC, ResolianDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

Merck stole the show at the European Society for Medical Oncology (ESMO) annual conference, with new data on its Moderna-partnered personalized cancer vaccine leaking prior to the presentation and antibody-drug conjugate sac-TMT making a splash in endometrial cancer; Bristol Myers Squibb revealed the death of a patient with multiple sclerosis in an early-stage trial of zola-cel; and pharma is on track to easily surpass last year’s deal count.

In this episode of Denatured, you’ll hear from Bruce Culleton, CEO at ProKidney and Demetri Maxim, CEO at Nephrogen. We discuss why kidney disease has long been a hard target for cell and gene therapies, and what new delivery strategies, therapeutic approaches and regulatory clarity mean for commercially viable products.HostJennifer C. Smith-Parker, Director of Insights, BioSpaceGuestsBruce Culleton, CEO, ProKidneyDemetri Maxim, CEO, NephrogenDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

China cracks down on some biotechnology ownership transfers—but will the new policy impact licensing deals?; Disc Medicine’s Phase 3 data sweep redeems rejected rare disease therapy, teeing up another FDA run; and the ESMO conference gets underway in Madrid this week, with much-anticipated data from Merck and Summit Therapeutics. 

BioSpace Vice President Chantal Dresner and Angela Gabriel, content manager, life sciences careers, cover what happened in the biopharma job market during the third quarter. They discuss encouraging signs for those looking for their next opportunity, such as improved job postings live on the BioSpace website and a dramatic drop in layoffs. Other topics include signs of industry health, news about job opportunities and advice for the Q4 job hunt. 

In this episode of Denatured, sponsored by Cytiva, Jennifer Smith-Parker speaks to Nicolas Pivet, VP & GM, Manufacturing & Digital Solutions at Cytiva. In this episode, we discuss how biopharma has long invested in more data and visibility, yet many programs still face delays and scale-up surprises. The real challenge isn’t information overload—it’s building confidence in the decisions that steer scientific progress from development through commercialization.This episode is presented in partnership with Cytiva. HostJennifer Smith-Parker, Director of Insights, BioSpaceGuestNicolas Pivet, VP & GM, Manufacturing & Digital Solutions, CytivaDisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations

Johnson & Johnson beat analyst expectations in the third quarter but left Wall Street wanting more; BMS dominated the news cycle on Monday with a Phase 3 win validating its $4.1 billion RayzeBio buy and mixed data in a late-stage pulmonary fibrosis trial; Revolution Medicines’ newly approved pancreatic cancer drug works better for patients with certain mutations; and Caribou Biosciences may be on its way out.