Post-Hoc Live

The biotech and pharma industry might be reaching breaking point with the FDA. Moderna said on Tuesday that the agency won’t review its mRNA-based flu vaccine — and through unusually public disclosures, accused the FDA of changing agreed-upon standards for its trial. And in responses to Endpoints’ Q1 Biopharma Sentiment Index, industry insiders unloaded their frustrations and fury with US officials and the regulatory system. Today on Post-Hoc Live, the Endpoints team unpacks the many, many straws that could have broken this camel’s back.

It’s only been a month since the FDA signed off on Novo Nordisk’s pill version of its weight-loss drug Wegovy, and the telehealth company Hims & Hers already says it’s going to sell a cheaper, compounded version of the pills. Novo is not happy — to say the least. Today on the show, we’ll dig into this new front in the compounding wars.

How existential are the current threats to US science? Noubar Afeyan, founder and CEO at Flagship Pioneering, joined us to point out the various landmines dotting the landscape during a live taping of Post-Hoc Live out at the JP Morgan Healthcare Conference.

It was a chaotic first year for this Trump administration’s FDA. The agency is down thousands of staff. Leadership was unstable. Industry insiders say they worry about the regulatory environment. What’s next? We’re joined by Holly Fernandez Lynch, an assistant professor of medical ethics at University of Pennsylvania's medical school and an FDA expert, to take stock of the past year at the FDA and look ahead to what we might see in year two.

The Endpoints newsroom has spent the past few weeks taking stock of the year and picking our 2025 biopharma winners and losers. Who (or what) was up, down, or on the rebound in 2025? We’ll reveal our picks and send you off into the holidays in style.

Derek Lowe is one of the biopharma industry’s most prolific commentators — in just the past month, he’s written about generic drug manufacturing, Sarepta, and the TrkB receptor in his column, In the Pipeline. He joins Post-Hoc Live to talk about the state of drug discovery, being a skeptic, and what he has his eye on next.

The relationship between big pharma and the UK turned south this year. Companies like Eli Lilly and Bristol Myers Squibb want the NHS to pay more for drugs, and others are playing hardball by pulling investments and sharply criticizing the government. And every action is wrapped up in the companies' “most favored nation” negotiations with the Trump administration. Ahead of the Financial Times’ Global Pharma and Biotech Summit, held in partnership with Endpoints, Financial Times global pharmaceutical editor Hannah Kuchler joins Post Hoc Live to offer the view from her side of the pond on how the UK and Europe are reacting to pharma's shifting global politics.

In February, a team of scientists achieved a long-held scientific goal — creating a bespoke CRISPR editing therapy to treat a single patient with a unique genetic mutation. “Baby KJ” got his own custom treatment only six months after he was born. Now, Rebecca Ahrens-Nicklas, a pediatrician and gene therapy scientist at CHOP, and Kiran Musunuru, a UPenn gene editing scientist, have a plan to replicate that success. They’re joining Post-Hoc Live to talk about what’s next.

The obesity wars just got spicier. Today, a month after Pfizer said it would buy Metsera, Novo Nordisk swooped in with its own bid for the cardiometabolic drug developer. Metsera says Novo’s offer is “superior.” Pfizer says it’s breaking their terms. We’ll tell you what comes next on Post-Hoc Live with BMO Capital Markets Head of Healthcare Research Evan Seigerman.

Don’t look now, but there are signs of life in the biotech market. The XBI has been ticking up. There were 22 M&A deals in Q3, according to John Carroll’s analysis with DealForma, and deal values are already close to the totals from all of 2024. Is it a mirage, or is the worst really over? And how much will we jinx things by saying it out loud? John and Tim Opler, Managing Director at Stifel's Global Healthcare Group, will join the show to break it all down.