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.
- Update frequency
- every 4 days
- Average duration
- 18 minutes
- Episodes
- 165
- Years Active
- 2023 - 2025
What Do AI and Hammers Have in Common?
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. Unders…
China Crackdown, UK Exit, Novo Layoffs, Adcomm Flip Flop, More
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 …
Unpacking the Latest MAHA Report, RFK’s Senate Appearance, FDA’s CRL Drop and More
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 diseas…
The 'Research Safety Net' Saving Scientists from Funding Crisis
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 t…
CDC Faces Critical Meetings Amid COVID Vaccine Uncertainty, Plus Deals, FDA Approvals, More
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 …
Lilly’s Obesity Pill Heads to the FDA, AbbVie Bets on Psychedelics, HHS Unveils More Change
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 m…
Oral Weight-Loss Race Heats Up as New Data From Lilly, Viking Reset Expectations
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…
Why AI Won't Save the 90% of Clinical Trials That Still Fail
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 …
MAHA Report Emphasizes Vaccines, Safety Vexes Viking’s Obesity Win, Novo Gains Momentum
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 Dona…
The Hidden Patent Crisis That Could Break Biotech: What Every CEO Needs to Know
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 Fa…
Prasad Returns, Delany Departs, Lilly’s Weight Loss Pill Disappoints and Sarepta’s Fallout Continues
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 ex…
From Chat Bots to World Order: The Race for the 21st Century's Operating System
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 funda…
FDA In Flux, Pfizer Talks to Trump on MFN, Merck Cuts 6K Jobs, More
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 rec…
We Don't Own Patient Data–We're Just Babysitting It
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…
Sarepta Gets Reprieve, RFK Jr.’s New Changes, Roche’s Alzheimer’s Comeback and Q2 Earnings
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 determin…
Sarepta’s Wild Week, CDER’s New Leader, FDA Rejections, Manufacturing Billions
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 …
Why Countries Are Racing to Build mRNA Factories While America Hesitates on Next-Gen Vaccines
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 t…
AI Is Taking Over Drug Safety Monitoring–But There's One Thing It Can't Replace
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 epi…
FDA Layoffs, 200 Rejection Letters, User Fees and Priority Vouchers, Bad Week for Rare Disease
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 “law…
Bonus Episode: Q2 2025 Job Market Update
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 …