BioSpace

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.
Host
Jennifer C. Smith-Parker, Director of Insights, BioSpace
Guests
Lewis Bender, President & CEO, Intensity Therapeutics
Paul-Peter Tak, President, CEO and Board Director, Candel Therapeutics
Disclaimer: 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.
Host
Jennifer C. Smith-Parker, Director of Insights, BioSpace
Guests
Jerome Barley, Commercial Director, Avion Medical
Ryan Klein, Vice President, Business Development, US and APAC, Resolian
Disclaimer: 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.