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BioSpace - Podcast

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.

Science Life Sciences
Update frequency
every 4 days
Average duration
18 minutes
Episodes
165
Years Active
2023 - 2025
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The mRNA Revolution You Haven't Heard About: From Cystic Fibrosis to Personalized Cancer Vaccines

The mRNA Revolution You Haven't Heard About: From Cystic Fibrosis to Personalized Cancer Vaccines

This discussion focuses on how mRNA and self-replicating RNA (srRNA) technologies are expanding far beyond COVID vaccines into revolutionary therapeutic applications for cancer and rare diseases. It …

00:14:21  |   Thu 10 Jul 2025
Second Half Milestones, KalVista’s Surprise Approval, Another RFK Jr. Lawsuit, More

Second Half Milestones, KalVista’s Surprise Approval, Another RFK Jr. Lawsuit, More

While most of the U.S. was celebrating the 4th of July holiday, President Donald Trump was busy signing the One Big, Beautiful Bill into law. This wide-ranging tax law has a few implications for the …

00:23:15  |   Wed 09 Jul 2025
CAR T Expands, M&A Ticks Up, Two Psychedelics Read Out, and the Supreme Court Rules on PrEP

CAR T Expands, M&A Ticks Up, Two Psychedelics Read Out, and the Supreme Court Rules on PrEP

The U.S. Supreme Court closed out its session before breaking for summer on Friday, ruling that decisions around coverage of HIV PrEP drugs should be left up to the U.S. Preventive Services Task Forc…

00:23:48  |   Wed 02 Jul 2025
Understanding the FDA's AI Guidance in Pharmacovigilance

Understanding the FDA's AI Guidance in Pharmacovigilance

In this episode of Denatured, Archana Hegde from IQVIA discusses the practical challenges faced by pharmacovigilance (PV) professionals as they navigate the FDA's first draft guidance for AI in drug …

00:24:30  |   Tue 01 Jul 2025
FDA Churn Continues, RFK Faces Congress, Obesity Insights at ADA, BIO2025 Recap

FDA Churn Continues, RFK Faces Congress, Obesity Insights at ADA, BIO2025 Recap

Robert F. Kennedy Jr. testified in front of the House Committee on Energy and Commerce Tuesday, where Democrats confronted the health secretary on hot button issues ranging from his recent overhaul o…

00:33:16  |   Wed 25 Jun 2025
Navigating Funding Freezes and AI Frontiers

Navigating Funding Freezes and AI Frontiers

Lori Ellis, head of insights at BioSpace, discusses some of the recent events and topics that are buzzing around BIO and DIA in 2025 with Rich Daly, CEO of Catalyst Pharmaceuticals, Peter Ronco, CEO …

00:27:26  |   Thu 19 Jun 2025
Another Gene Therapy Death; Biopharma M&A Picks Up; a Vaccine Board of Vaccine Skeptics

Another Gene Therapy Death; Biopharma M&A Picks Up; a Vaccine Board of Vaccine Skeptics

This week, BioSpace is at 50% power as Heather McKenzie and Jef Akst are off attending this year’s BIO Conference in Boston. The half-team discusses this week’s biggest news: the death of another pat…

00:20:02  |   Wed 18 Jun 2025
RFK Axes CDC Vaccine Advisors ; Metsera’s Weight Loss Win; FDA Supports CGT

RFK Axes CDC Vaccine Advisors ; Metsera’s Weight Loss Win; FDA Supports CGT

This week the BioSpace team was sent into an after-hours scramble by the news that Health and Human Services Secretary Robert F. Kennedy Jr. had fired the remaining members of the CDC’s Advisory Comm…

00:20:58  |   Wed 11 Jun 2025
AI's Role in Decoding the FDA's New Regulatory Communications

AI's Role in Decoding the FDA's New Regulatory Communications

In a dynamic regulatory environment, IQVIA’s Michelle Gyzen suggests that AI may be the best and only way to keep with changes that are happening daily–and sometimes hourly.

In this discussion Lori an…

00:15:09  |   Thu 05 Jun 2025
M&A Ticks Up, ASCO Excites and Vaccines Cause More Drama

M&A Ticks Up, ASCO Excites and Vaccines Cause More Drama

The words of the week so far in biopharma are “deals” and “cancer”—or, more specifically, money being invested in cancer and other key therapeutic areas. With the American Society of Clinical Oncolog…

00:20:52  |   Wed 04 Jun 2025
COVID-19 Vaccine Overhaul, Rocket Grounded, ‘One Tough Hombre’ on MFN

COVID-19 Vaccine Overhaul, Rocket Grounded, ‘One Tough Hombre’ on MFN

The name of the biopharma game this season is vaccines—and RFK Jr. wasted no time returning from Memorial Day Weekend before making news on this front, removing the COVID-19 vaccine from the list of …

00:20:13  |   Wed 28 May 2025
How Target Product Profiles Guide the Industry Through Uncertain Times

How Target Product Profiles Guide the Industry Through Uncertain Times

Lori Ellis, head of insights and Ian Fisher, head of development of analytics at IQVIA, discusses the critical importance of Target Product Profiles (TPPs) for life sciences companies, especially dur…

00:29:14  |   Thu 22 May 2025
Pfizer’s $6B China Deal, Drug Pricing and FDA’s New COVID Vaccine Plan

Pfizer’s $6B China Deal, Drug Pricing and FDA’s New COVID Vaccine Plan

Pfizer stole the headlines this week with a pact worth up to $6 billion with Chinese biotech 3SBio for a PD-1/VEGF candidate just three months after inking a clinical trials collab for a similar drug…

00:22:39  |   Wed 21 May 2025
Trump’s Drug Pricing Policy, Prasad’s CBER Nod, Bayer’s Layoffs and Galapagos’ Next Chapter

Trump’s Drug Pricing Policy, Prasad’s CBER Nod, Bayer’s Layoffs and Galapagos’ Next Chapter

President Donald Trump unveiled a sweeping drug pricing policy this week, seeking to lower drug prices in the U.S. by up to 80% through a reprisal of the Most Favored Nation rule he attempted to intr…

00:31:06  |   Wed 14 May 2025
Eroding Immunity: Vaccine Hesitancy and Cynicism

Eroding Immunity: Vaccine Hesitancy and Cynicism

Paul Offit, MD, Director of the Vaccine Education Center at the Children's Hospital of Philadelphia and the Maurice R. Hilleman Professor of Vaccinology, Professor of Pediatrics at the Perelman Schoo…

00:28:11  |   Thu 08 May 2025
Trump’s US Manufacturing Push, New Vaccine Policy, Novo’s Weight Loss Pill up for FDA Review

Trump’s US Manufacturing Push, New Vaccine Policy, Novo’s Weight Loss Pill up for FDA Review

In his effort to onshore manufacturing, President Donald Trump issued an executive order on Monday afternoon ordering the FDA to ease permitting processes for new and expanded U.S. facilities. The an…

00:24:16  |   Wed 07 May 2025
Tariffs Continue to Dominate Q1 Earnings, AACR Excites Cancer Space, CEO Pay Gaps, More

Tariffs Continue to Dominate Q1 Earnings, AACR Excites Cancer Space, CEO Pay Gaps, More

Policy issues—particularly tariffs—loom large as Q1 2025 earnings season rolls on, with Pfizer , Novartis, AstraZeneca and many more all reporting this week. On Pfizer’s call, CEO Albert Bourla calle…

00:24:09  |   Wed 30 Apr 2025
Economic Challenges, Strategic Investments: Reshaping the Women's Health Landscape

Economic Challenges, Strategic Investments: Reshaping the Women's Health Landscape

This discussion features BioSpace's head of insights Lori Ellis, Kearney partner Martin Hadosi, and Melissa Laitner, director of strategic initiatives at the National Academy of Medicine emphasizing …

00:10:34  |   Thu 24 Apr 2025
Makary’s First Interview, US Manufacturing Push and Lilly vs. Novo in Obesity Pill Race

Makary’s First Interview, US Manufacturing Push and Lilly vs. Novo in Obesity Pill Race

While much of the country was off celebrating Easter and Passover this weekend, the FDA—and its new leader Marty Makary—were busy making news. Makary, who was confirmed as FDA commissioner last month…

00:18:16  |   Wed 23 Apr 2025
Tariff Turmoil, FDA’s Future, Pfizer’s Obesity Setback and CEO Salaries Revealed

Tariff Turmoil, FDA’s Future, Pfizer’s Obesity Setback and CEO Salaries Revealed

It’s all about tariffs again this week. No sooner had Donald Trump announced that “major” tariffs on the pharmaceutical industry would be coming “very shortly”—sending stocks spiraling—the president …

00:21:00  |   Wed 16 Apr 2025
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