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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…
10 months, 3 weeks ago
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…
10 months, 3 weeks ago
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 sup…
11 months ago
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 V…
11 months ago
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 addre…
11 months, 1 week ago
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…
11 months, 1 week ago
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 muscula…
11 months, 2 weeks ago
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 oc…
11 months, 2 weeks ago
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 qualifie…
11 months, 3 weeks ago
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 su…
11 months, 3 weeks ago