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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

00:32:12

FDA’s Autism Endeavor, Pfizer’s Obesity Comeback Bid,...

BioSpace ·

2025/09/24

The FDA is working to reapprove GSK’s long-dormant drug Wellcovorin (leucovorin) for cerebral folate deficiency, which the agency linked to “developmental delays with autistic features.” This immediately followed a much-anticipated press conference in which President Donald Trump, flanked by Health Secretary Robert F. Kennedy Jr and other healthcare administrators, linked the use of Tylenol during pregnancy to rising rates of autism. Meanwhile, Pfizer woke us all up Monday with the news that it had

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00:22:20

What Do AI and Hammers Have in Common?

BioSpace ·

2025/09/18

In this episode, Lori Ellis and Colin Zick spend a little time further discussing some of the points brought up in the Bioprocessing Summit last month. AI is a tool, a powerful one but a tool. Understanding this, they explore the connections between hammers, AI, The Planet of the Apes and monoliths.In the end, it is all about compliance.Host⁠⁠⁠⁠⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠⁠⁠⁠⁠, Head of Insights, BioSpaceGuestColin Zick, Partner, Foley Hoag LLP Disclaimer: The views expressed in this discussion by guests are

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00:27:02

China Crackdown, UK Exit, Novo Layoffs, Adcomm Flip...

BioSpace ·

2025/09/17

A global shift may be underway in biopharma as the White House prepares legislation that would would place restrictions on drugs brought to the U.S. from China, and pharma companies exit the U.K. in droves. President Donald Trump is reportedly writing an executive order that would clamp down on the pharmaceutical industry’s ability to buy new molecules from biotechs based in China, while Sanofi, Merck and more have canceled or suspended investments in the U.K. following a sizeable increase in a

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00:32:05

Unpacking the Latest MAHA Report, RFK’s Senate...

BioSpace ·

2025/09/10

The Make America Healthy Again Commission released itssecond report Tuesday, recommending, among other efforts, an investigation into a possible link between vaccines and the uptick in chronic disease. At a livestreamed MAHA commission meeting, Health Secretary Robert F. Kennedy painted a dire picture of the country’s health, saying the U.S. now has “the highest chronic disease burden of any country in the world.” Looking back to last week, all eyes were on HealthSecretary Robert F. Kennedy Jr.’s

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00:17:08

The 'Research Safety Net' Saving Scientists from...

BioSpace ·

2025/09/04

In this episode, Mike Garrett, CEO of Taconic Biosciences, discusses how preclinical research companies are helping drug developers navigate the current challenging funding environment. He explains that investors now demand more robust translational data showing real potential to impact human health, rather than just basic in vitro results, forcing researchers to generate better evidence packages earlier in development.This episode is presented in partnership with ⁠⁠Taconic

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00:31:29

CDC Faces Critical Meetings Amid COVID Vaccine...

BioSpace ·

2025/09/03

We returned from the Labor Day holiday to a spate of intriguing deals, including two that could surpass $2 billion: Vertex’s new pact with Enlaza for autoimmune disease—which the Casgevy maker hopes could ease conditioning for the sickle cell/beta thalassemia gene therapy—and Novartis’ agreement with Arrowhead for neurodegenerative diseases such as Parkinson’s. But as we look ahead, Thursday’s Senate Finance Committee will be the focus this week, as Health and Human Services Secretary Robert F

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00:22:40

Lilly’s Obesity Pill Heads to the FDA, AbbVie Bets on...

BioSpace ·

2025/08/27

Eli Lilly posted data Tuesday from a second Phase III trial of its oral weight loss therapy orforglipron, providing the company with all it needs to head to the FDA with a new drug application. For more in-depth discussion on the oral weight-loss space, check out a special episode of The Weekly. And stay tuned to BioSpace for more unique coverage of this market as we learn which investigational assets will make it across the regulatory finish line and which will join the weight-loss wasteland. On

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00:17:54

Oral Weight-Loss Race Heats Up as New Data From...

BioSpace ·

2025/08/26

Oral therapies are projected to account for 25% of the anti-obesity medication market by 2030—but first returns have largely disappointed. This month, shares of both Eli Lilly and Viking Therapeutics took a hit as investors reacted negatively to highly anticipated Phase III and Phase II results for their respective candidates.While the 9.1% placebo-adjusted weight loss generated by Lilly’s orforglipron over 72 weeks was an efficacy miss by most analyst accounts, tolerability tripped up oral VK2735’s

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00:24:09

Why AI Won't Save the 90% of Clinical Trials That...

BioSpace ·

2025/08/21

While AI represents a significant advancement in efficiency for early-stage drug discovery, it won't dramatically change the 90% clinical trial failure rate. Most failures stem from fundamental gaps in biological understanding rather then the processes where AI is able to have the most impact.The discussion highlights AI's strengths and ability to reduce preclinical costs. However, they caution that AI faces significant limitations in predicting complex biological properties like toxicity

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00:29:14

MAHA Report Emphasizes Vaccines, Safety Vexes...

BioSpace ·

2025/08/20

Three months after taking heat over an error-riddled first report, Health Secretary Robert F. Kennedy’s Make America Healthy Again Commission was due to submit a new strategy report to President Donald Trump last week. While the report is delayed—for disputed reasons— Politico obtained a draft copy, which homes in on creating a new vaccine framework and streamlining access to investigational drugs, specifically for children. The new strategy also touches on pharma lobbying, with plans to address

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00:25:32

The Hidden Patent Crisis That Could Break Biotech:...

BioSpace ·

2025/08/14

In this Denatured discussion, the conversation revolves around unpacking the patent policy changes that could make or break biotech companies. Guests Aaron Cummings and Anne Li of Brownstein Hyatt Farber Schreck highlight critical issues posed by the Patent Office including recent changes to the Inter Partes Review (IPR) such as discretionary denial and a proposed patent property tax.Cummings and Li also discuss how biopharma can work with the administration as changes are being proposed and

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00:22:50

Prasad Returns, Delany Departs, Lilly’s Weight Loss...

BioSpace ·

2025/08/13

Vinay Prasad is back at the FDA as chief of the FDA’s Center for Biologics Evaluation and Research. Prasad’s return—which hit the news wires Saturday morning—came just 10 days after his unexpected exit on July 29, following blowback over the saga involving Sarepta Therapeutics’ Duchenne muscular dystrophy gene therapy Elevidys, and a campaign by conversative personalities to oust the outspoken physician.Elsewhere in the government, Gray Delany, former head of HHS’ and President Donald Trump’s Make

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00:20:12

From Chat Bots to World Order: The Race for the 21st...

BioSpace ·

2025/08/07

In this thought-provoking episode, Cresset Group’s CSO, Mark Mackey, and VP of AI, Mutlu Dogruel, dissect the emerging geopolitical battle for AI supremacy, revealing how China's DeepSeek model fundamentally disrupted the AI landscape by achieving GPT-4 level performance for just $6 million versus OpenAI's reported $100+ million investment. The discussion exposes a critical divide in global AI governance: Europe's "regulatory fortress" approach with the AI Act creates strict but vague rules that

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00:26:29

FDA In Flux, Pfizer Talks to Trump on MFN, Merck Cuts...

BioSpace ·

2025/08/06

Center for Drug Evaluation and Research Head George Tidmarsh will oversee the Center for Biologics Evaluation and Research on an acting basis after Vinay Prasad’s abrupt departure hours after the recording of last week’s episode of The Weekly. While the situation is being billed as temporary, rumors are swirling that structural changes may be afoot at the FDA with Commissioner Marty Makary looking for better drug, biologic alignment.Meanwhile, the agency has come under criticism for another recent

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00:22:59

We Don't Own Patient Data–We're Just Babysitting It

BioSpace ·

2025/07/31

While AI excels at repetitive tasks like triaging medical information calls, document retrieval, and adverse event detection, the industry must address valid concerns from physicians (41% are excited but concerned, according to AMA studies) and patients who distrust AI systems. In this episode, IQVIA’s Louise Molloy advocates for complete transparency, including clear disclaimers when AI generates or supports responses, arguing that the industry serves as "custodians, not owners" of patient data

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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

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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

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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

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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.

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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

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166 results

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