When you see whooping cough in the headlines, you probably imagine the Roaring 20s, the Great Depression, or maybe even the Oregon Trail. Side note, all of the 90’s kids out there know you most likely died from dysentery on the Oregon Trail, not whooping cough. But if we’re talking the real Oregon Trail and not the floppy disk version, whooping cough was a real threat.

But here we are in 2025. Jazz has been replaced by TikTok remixes and pertussis is suddenly pulling a full-on comeback tour.

Roche just scored clearance in both the US and Europe for a new point-of-care test that nails Bordetella infections fast. The timing couldn’t be more on-the-nose: cases are climbing across multiple countries, and clinicians need quick diagnostics yesterday.

So yes, while everything old becomes new again. From vintage clothes, to vinyls, to mushroom lamps. We probably could’ve left this retro trend in the archives.

⚖️ CDC Vaccine Vote Sparks a Firestorm. The CDC’s vaccine advisers voted to revise long-standing hepatitis B guidance for newborns, and the backlash arrived almost instantly. Critics say the change muddies what was once a clear standard of care, and some public health groups worry it could create gaps in protection for high-risk infants. ACIP is already under pressure on other vaccine decisions, and this one isn’t helping the optics. Stay tuned, because this debate isn’t cooling off.

💰 Wuxi Back in Washington’s Crosshairs. After dodging the BioSecure Act’s harshest penalties, Wuxi AppTec is now facing renewed scrutiny from the Pentagon. Officials are eyeing potential national security risks tied to the company’s global footprint and sensitive manufacturing capabilities. The concern: supply chain exposure, data handling, and how much US biotech relies on China-based partners. Expect more hearings, more headlines, and fewer sighs of relief from Wuxi.

⚖️ Lawmakers Push New Biomanufacturing Bill. Congress is floating a bill to establish a US biopharma manufacturing “center of excellence.” Think of it as a federal training gym for domestic production. Part policy, part industrial pep rally. Proponents say it’s the only way the US stays competitive as Europe and Asia build out billions in capacity. Critics say it’s unclear how this solves real-world bottlenecks. Either way, everyone seems to agree: manufacturing is having a moment.

🧪 Breyanzi Scores Another FDA Win. BMS just landed its fifth approval for CAR-T therapy Breyanzi, this time for adults with relapsed or refractory marginal zone lymphoma. It’s the first and only CAR-T option for this patient group, expanding access and strengthening BMS’s leadership in cell therapy. With competition heating up in hematologic cancers, every new label matters, and this one arrived with impeccable timing.

💰 FDA Floats New User Fee Tweaks. The FDA is proposing a fee cut for early-stage trials conducted in the US, paired with higher fees for companies running Phase I studies overseas. The intended message: invest at home. The unintended message: US-based biotech wins again. Industry watchers are waiting to see how smaller global biotechs respond, especially as early clinical work becomes increasingly international.

Imagine spending years climbing the ladder, earning a top federal role, stepping into the job… and then pulling a Forrest Gump: “I think I’ll go home now.”

That’s pretty much the vibe coming out of the FDA lately.

Between abrupt exits, interim leaders stepping in at warp speed, and coalitions sounding alarms, the agency is giving off the energy of a biotech startup where the head of R&D quits during orientation. Except this time it’s the agency that oversees the nation’s drug supply, vaccine policy, and clinical trial standards. No pressure.

🔥 The Departures Keep Stacking Up

Richard Pazdur, one of the most influential figures in oncology drug approvals, is stepping away, triggering warnings from industry leaders who say the FDA is hitting a tipping point. Meanwhile, long-tenured veterans are heading for the exits, leaving only a handful of senior leaders with deep institutional memory.

Other directors are shifting roles or exiting entirely, including the head of the nonprescription drug office. And as leadership thins, the agency keeps appointing acting heads, like Tracy Beth Hoeg, to plug sudden gaps.

⚡ The Policy Turbulence Isn’t Helping

The churn isn’t just personnel. Policy fights are adding fuel.

A dozen former FDA commissioners blasted newly proposed vaccine policy changes, calling them destabilizing and politically charged. Industry groups say the turmoil is starting to spill into regulatory consistency, especially around clinical trial expectations. Some insiders believe the internal push to revise trial standards (one of the rumored triggers behind Pazdur’s departure) could ripple across oncology development for years.

🧨 Why It Matters for Biotech

When biotech investors say the market is “fragile,” they’re not being dramatic. Regulatory predictability is the backbone of early-stage funding, and right now predictability is… not the word anyone would use.

mRNA groups, patient coalitions, and policy analysts are all flagging the same thing: this level of instability is unprecedented. Even the rumor mill is exhausted.

If the FDA were a biotech company, the comment section would be asking when the CEO is getting replaced. Except the CEO already left.

🫠 The Real Question

At this point, biotech founders are keeping one eye on trial data and the other on LinkedIn to see who updates their job title next. The only thing more volatile than small-cap biotech stocks might be the FDA’s org chart.

Pharma companies have committed an eye-popping $370B to US manufacturing investments during the ongoing onshoring boom. The scramble to build domestic capacity isn’t slowing down, and policy proposals surfacing in Congress suggest that even more federal incentives could be on the way.

Reddit had some feelings this week. And they did not hold back.

• “Contractor life is rough.” One Genentech contractor recapped the usual hits: treated like a second-class citizen, excluded from team events, grueling interviews, and promises of FTE conversion that age like milk.

• “FDA? Downward spiral.” Users reacting to leadership exits say the agency looks less like a regulator and more like a sinking ship with too many lifeboats already deployed.

• “Biotech’s instability is next-level.” With FDA turmoil and shaky markets, one commenter joked it might be time to open that hot dog stand they’ve been daydreaming about. Honestly? Could be more stable than biotech right now.

🤖 Medtronic’s Hugo surgical robot gets US clearance. More robotic arms entering the OR, fewer excuses for shaky hands.

🧲 Triana scores $120M to advance molecular glue degraders. Pfizer-backed, clinic-bound, and officially buzzworthy.

🙈 FDA floats guidance to reduce primate testing for certain antibodies. A shift researchers have been calling for.

📉 Janux stock cratered 48% overnight. This was in reaction to disappointing PSMA x CD3 immunotherapy data. Analysts still think it could be best-in-class someday, just not today.

“Somewhere, something incredible is waiting to be known.”

— Carl Sagan

🧬 Why do biologists look forward to casual Fridays?
Because they’re finally allowed to wear genes to work.

That’s all for this week. See you next time 👋

And honestly, at the pace things are going, we’re genuinely curious which FDA official will quit before the next issue hits your inbox.

Reply anytime. We are always happy to hear what’s happening in your corner of biotech.

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