x

75% of people globally want unbiased news (Pew Research) but are concerned they're not getting that.

Get balanced coverage with Symby. See how stories are covered across diverse outlets and spot when one side covers a story the other skips.

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

All Episodes

00:19:17

Sarepta Gets Reprieve, RFK Jr.’s New Changes, Roche’s...

BioSpace ·

2025/07/30

The Sarepta saga continued into another week as the FDA recommended that the voluntary hold on the company’s Duchenne muscular dystrophy gene therapy be lifted for ambulatory patients, after determining that the death of an 8-year-old Brazilian Duchenne patient who had received Elevidys’ was not caused by the drug. Sarepta’s stock has swung wildly and its transparency questioned after it elected not to reveal the death of a third patient—a participant in a trial of a gene therapy for limb girdle

en

00:24:12

Sarepta’s Wild Week, CDER’s New Leader, FDA...

BioSpace ·

2025/07/23

Just a few weeks ago, it seemed like Sarepta had weathered a spate of bad news, after two patients died from liver injuries from its Duchenne muscular dystrophy gene therapy Elevidys. Then came news of a third patient death. Last Wednesday, the company announced a major restructuring and 500-person layoff. Then, in just a few days time, Sarepta Therapeutics went from enjoying a notable stock bump in response to that corporate update to its lowest price in nearly 10 years as it halts shipments of

en

00:15:19

Why Countries Are Racing to Build mRNA Factories...

BioSpace ·

2025/07/22

This episode continues the discussion regarding the rapid evolution of mRNA technologies since COVID-19. Guests discuss the improvements that have occurred within just a few years, which are making these therapies more reliable, cost-effective and viable for personalized cancer, rare disease chronic disease treatment.Today’s episode is sponsored by Eclipsebio. From AI-ready datasets to sequencing validation, they drive RNA success.Explore their solutions at ⁠https://eclipsebio.com/⁠.Host⁠⁠⁠⁠⁠⁠Lori

en

00:13:07

AI Is Taking Over Drug Safety Monitoring–But There's...

BioSpace ·

2025/07/17

This episode focuses on how AI is transforming pharmacovigilance (PV) on a global scale, particularly focusing on the evolving role of local qualified persons for pharmacovigilance in the EU.This episode is presented in partnership with IQVIA.Host⁠⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠⁠, Head of Insights, BioSpaceGuestAna Pedro Jesuíno, Global Head Local QPPV Network, IQVIADisclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

en

00:25:46

FDA Layoffs, 200 Rejection Letters, User Fees and...

BioSpace ·

2025/07/16

Up to 3,500 FDA staffers received their final walking papers Monday after the U.S. Supreme Court found last week that the government is “likely to succeed” in arguing that its overhaul of HHS is “lawful.” Meanwhile, FDA Commissioner Marty Makary floated policy changes for the agency, including a proposal to lower prescription drug user fees for the next iteration of the program, and one to offer speedier reviews to companies willing to lower the cost of their drugs. Last week, the regulator opened

en

00:08:35

Bonus Episode: Q2 2025 Job Market Update

BioSpace ·

2025/07/15

In this discussion, BioSpace’s vice president of marketing ⁠⁠Chantal Dresner⁠⁠ and careers editor ⁠⁠Angela Gabriel⁠⁠ take a look at job market performance in the second quarter of 2025. They discuss job posting trends, application rates and the most significant layoffs of 2025 so far, plus wider trends impacting biopharma including Massachusetts’ $30M tax incentives and factors affecting California’s success. Want to receive our latest quarterly job market reports as soon as they’re

en

00:14:21

The mRNA Revolution You Haven't Heard About: From...

BioSpace ·

2025/07/10

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 is clear that mRNA therapeutics offer three major application areas: infectious disease vaccines, therapeutic vaccines for oncology, and protein replacement for monogenic rare diseases.Today’s episode is sponsored by Eclipsebio. From AI-ready datasets to sequencing validation, they drive RNA success

en

00:23:15

Second Half Milestones, KalVista’s Surprise Approval,...

BioSpace ·

2025/07/09

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 biopharma industry, including expanded IRA exemptions for orphan drugs. Looking ahead to the second half of 2025, BioSpace reviews some of the upcoming catalysts highlighted by Jefferies’ “Halftime Show” report,including a highly anticipated Phase III readout for Eli Lilly’s oral obesity candidate

en

00:23:48

CAR T Expands, M&A Ticks Up, Two Psychedelics Read...

BioSpace ·

2025/07/02

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 Force. The ruling thwarted a lawsuit brought by a group of insurance providers who challenged the Affordable Care Act’s requirement that they cover preventive medicines, such as HIV drugs, recommended by the task force. The high court also determined that members of this task force can be removed at will by

en

00:24:30

Understanding the FDA's AI Guidance in Pharmacovigilance

BioSpace ·

2025/07/01

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 development, published in January 2025. Hegde explains that the vagueness of the current framework is like “a recipe with no pictures and mystery ingredients." During the discussion, she highlights areas of existing confusion.This episode is presented in partnership with IQVIA.Host⁠⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠⁠,

en

00:33:16

FDA Churn Continues, RFK Faces Congress, Obesity...

BioSpace ·

2025/06/25

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 over the CDC’s Advisory Committee on Immunization Practices (ACIP) committee, Kennedy’s recently published—and error-ridden—MAHA report, and his threat to ban government scientists from publishing in certain medical journals. Meanwhile, at the FDA, the mass exodus of senior leadership continues. On

en

00:27:26

Navigating Funding Freezes and AI Frontiers

BioSpace ·

2025/06/19

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 of Emmes Corporation, and Phil Vanek, founder of Redline Bio Advisors. They address funding, the partnering market, AI, and also the recent FDA and CGT roundtable discussion.HostLori Ellis, Head of Insights, BioSpaceGuests⁠⁠Peter Ronco⁠⁠, CEO, Emmes⁠Phil Vanek⁠⁠, Founder, Redline Bio Advisors; Chief

en

00:20:02

Another Gene Therapy Death; Biopharma M&A Picks Up; a...

BioSpace ·

2025/06/18

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 patient who took Sarepta’s Duchenne muscular dystrophy gene therapy Elevidys. The patient was a non-ambulatory teenager who experienced acute liver failure after receiving the gene therapy, which is the same cause of death for an Elevidys patient reported in March. Sarepta announced that it was halting

en

00:20:58

RFK Axes CDC Vaccine Advisors ; Metsera’s Weight Loss...

BioSpace ·

2025/06/11

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 Committee on Immunization Practices. The secretary argued in an op-ed that accompanied the announcement that the “clean sweep” was necessary to “reestablish public confidence in vaccine science.” The move came amid heightening rhetoric from Kennedy about the safety of vaccines and sparked concerns that the

en

00:15:09

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

BioSpace ·

2025/06/05

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 and Michelle touch on the governance frameworks for cybersecurity, risk, and how AI transformation and integration is evolving to help regulatory professionals navigate the speed and complexity of global requirements.Host⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠, Head of Insights, BioSpaceGuestMichelle Gyzen, Sr. Director,

en

00:20:52

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

BioSpace ·

2025/06/04

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 Oncology’s annual conference underway in Chicago, Bristol Myers Squibb got in the PD-1/PD-L1xVEGF game, paying potentially more than $11 billion to co-develop BioNTech’s solid tumor bispecific BNT327. Elsewhere, Sanofi nabbed the year’s second-biggest buyout, picking up Blueprint for $9.5 billion, expanding its

en

00:20:13

COVID-19 Vaccine Overhaul, Rocket Grounded, ‘One...

BioSpace ·

2025/05/28

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 recommended immunizations for healthy kids and pregnant women on Tuesday. This follows a rash of recent moves, including a new risk-based strategy for the approval of new COVID vaccines focused on adults over 65 and high-risk individuals six months to 64 years of age and a request that Moderna and

en

00:29:14

How Target Product Profiles Guide the Industry...

BioSpace ·

2025/05/22

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 during uncertain times with funding challenges. Fisher emphasizes that TPPs serve as strategic guiding light which help companies articulate their development goals and demonstrate value to potential investors and partners.This episode is presented in partnership with IQVIA.Host⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠, Head of

en

00:22:39

Pfizer’s $6B China Deal, Drug Pricing and FDA’s New...

BioSpace ·

2025/05/21

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 with Summit Therapeutics. It’s the largest Chinese licensing deal in recent memory, as pharmas continue to turn to the country to fill their pipelines. Also on Tuesday, the Department of Health and Human Services offered a smidge more detail on President Donald Trump’s Most Favored Nation executive

en

00:31:06

Trump’s Drug Pricing Policy, Prasad’s CBER Nod,...

BioSpace ·

2025/05/14

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 introduce in his first term. The rule would essentially link U.S. prices to those paid in other nations where medications are cheaper. Biopharma reaction was one of tentative relief, with BMO Capital Markets analysts suggesting the executive order had “more bark than bite.” Meanwhile, the Centers for

en

191 results

Similar Podcasts

Classic Radio Science Fiction

solgoodmedia.com

Mission to Mars

Inception Point Ai

The 365 Days of Astronomy

365DaysOfAstronomy.org

Creek Devil

william Jevning

UFO Chronicles Podcast

Nik Hunter