👋 Good morning! Albert Bourla did not show up to the TD Cowen conference to speak in corporate riddles.

The Pfizer CEO looked straight at the FDA’s Center for Biologics Evaluation and Research and said what most executives have only whispered: “We have a problem with the leadership of CBER.”

The target was CBER Director Vinay Prasad. Bourla accused him of not following staff recommendations and drew a bright line between political leadership and the career scientists Pfizer has worked with for decades. The regulators? Still world class. The leadership? “An anomaly that will correct itself.”

That is not exactly how most pharma CEOs handle Washington.

While others have stayed quiet under the new administration, Bourla has repeatedly criticized HHS Secretary Robert F. Kennedy Jr. and now openly challenged vaccine oversight. He insists Pfizer is not changing strategy and vaccines are not going anywhere. “We are not going back to before Pasteur,” he said.

Translation: call it a disagreement, not a retreat.

💰 Sanofi Drops $1.5B on First-in-Class JAK/ROCK Play
Sanofi is paying $135 million upfront and up to $1.395 billion in milestones to secure global rights to rovadicitinib from Sino Biopharm’s subsidiary Chia Tai Tianqing. The oral drug is the first dual JAK/ROCK inhibitor, already approved in China for certain myelofibrosis patients. Sanofi sees bigger potential in chronic graft-versus-host disease, where a Phase 3 trial is underway in China and the FDA has cleared Phase 2 in the U.S. Specialty care shopping spree: still active.

✍️ UCB Enters TCE Arena With $1.1B Autoimmune Bet
UCB is paying $80 million upfront to license ATG-201, a CD19/CD3 bispecific T-cell engager from Shanghai-based Antengene. The preclinical candidate is heading into Phase 1 in China and Australia before transitioning to UCB. Total deal value could reach $1.1 billion plus royalties. Oncology’s favorite modality just found a new autoimmune address.

❌ HHS Bans Claude AI Across Agency Systems
The Department of Health and Human Services has blocked use of Anthropic’s Claude AI tool following White House tensions with the company. ChatGPT Enterprise and Google Gemini remain approved. The twist: the FDA’s internal AI tool Elsa was reportedly built on Claude. Faster reviews meet federal politics.

💸 Moderna Writes $950M Check to End mRNA Patent Fight
Moderna will pay $950 million upfront to settle long-running litigation with Genevant and Arbutus over lipid nanoparticle tech used in Spikevax. Up to $1.3 billion more could follow depending on government contract exposure. No future royalties. Expensive peace treaty.

🫁 United Therapeutics Cuts PAH Risk 55% in Phase 3
Ralinepag reduced the risk of clinical worsening by 55% in a 687-patient Phase 3 pulmonary arterial hypertension study. United plans to file for FDA approval in the second half of the year. The company believes once-daily dosing gives it an edge over Johnson & Johnson’s Uptravi, which pulled in $1.9 billion last year.

📩 FDA Fires Off 30 GLP-1 Warning Letters. The agency targeted telehealth companies for misleading marketing around compounded obesity drugs as the crackdown intensifies.

🇰🇷 Roche Pledges $480M to South Korea. The pharma giant signed an MOU to boost clinical trials and talent development in the country.

🧬 Regenxbio CRL Details Released. The FDA cited trial design, external controls, and surrogate endpoints in rejecting its Hunter syndrome gene therapy.

💰 Teva Secures $400M From Blackstone. The capital will fund development of its Sanofi-partnered anti-TL1A antibody duvakitug in IBD.

📉 Disc Cuts 20% of Staff After FDA Rejection. The rare disease biotech is trimming staff following a knockback of bitopertin.

🧬 Intellia Phase 3 Hold Lifted. The FDA removed the clinical hold on its ATTR-CM CRISPR trial after a prior liver toxicity concern.

✂️ BioAtla Slashes Workforce 70%. The antibody biotech is exploring strategic options, including potential asset sales.

Boston. San Diego. The Bay Area.

And… Holly Springs, North Carolina?

A town of about 50,000 residents is quietly becoming a front line in the obesity drug wars. Amgen and Roche are pouring more than $3.5 billion into manufacturing facilities there to challenge Eli Lilly and Novo Nordisk. Yes, the next GLP-1 battlefield might come with Southern humidity.

This did not happen overnight. Nearly 20 years ago, Holly Springs made a risky bet to attract Novartis with land, roads, water systems and serious infrastructure upgrades. It stretched finances thin. It also put the town on the biomanufacturing map.

Now the payoff is visible. Amgen is running seven Phase 3 trials of MariTide and scaling toward hundreds of jobs. Roche’s Genentech unit is advancing its dual GLP-1/GIP candidate CT-388 and expects its site online by 2029. Fujifilm just opened one of North America’s largest commercial-scale cell culture sites nearby, with capacity for 16 massive bioreactors at full buildout.

Why North Carolina? Talent and timing.

The Research Triangle draws from Duke, UNC, and NC State. The region now supports more than 75,000 life science workers, up from 35,000 fifteen years ago. Cost of living undercuts Boston and San Francisco. And in an era of reshoring pressure, U.S. manufacturing capacity is strategic currency.

But growth has side effects. Water, wastewater, and energy demands are rising. A proposed 300-megawatt data center nearby is already stirring debate about infrastructure strain. Biomanufacturing may be booming, but utilities still run on physics.

The bigger takeaway: biotech clusters are not just about discovery anymore. They are about pipes, power grids, and people who know how to run a 20,000-liter bioreactor at 2 a.m.

Holly Springs bet on infrastructure before it was cool. Now obesity drugs are lining up at the loading dock.

That is how far uniQure shares fell after the FDA rejected its plan to seek early approval for Huntington’s gene therapy AMT-130 using Phase 1/2 data and external controls. The agency is demanding a randomized, sham-controlled Phase 3 trial instead. For patients hoping for an expedited path, the timeline just stretched by years. For investors, the reaction was immediate.

The biotech job market continues to humble.

🫤 Lower your expectations… to zero.
One Redditor said they have stopped expecting callbacks altogether. If a company responds, great. If not, move on. Commenters agreed that employers are hunting unicorns and perfection has replaced potential. Apply, interview, rinse, repeat. Do not wait by the phone.

👨‍🍳 From Michelin Kitchen to Lab Bench?
Another biotech professional currently working as a station chef asked whether to hide the restaurant experience on their resume. The overwhelming response: absolutely include it. Michelin kitchens run tighter than most labs and it makes you memorable. In a sea of similar CVs, being “the chef candidate” might be your differentiator.

❤️ GLP-1s Aid Heart Recovery in Rodents. New data suggest the drugs help blood vessels relax after heart attack, adding another layer to their cardiovascular story.

🧑‍🔬 ARPA-H Launches $158M Lymphatic Push. The GLIDE program aims to develop the first medicines specifically targeting the lymphatic system.

🤖 Quest Diagnostics Debuts AI Chatbot. Patients can now query five years of their lab data through a Google-powered chatbot.

📺 FDA Flags Another Novo Ad. Regulators say an Ozempic campaign misrepresented efficacy, marking the second GLP-1 marketing warning in weeks.

🥜 Poplar Therapeutics Raises $95M to Rethink Food Allergy
Led by former 2seventy CEO Chip Baird, Poplar is advancing PHB-050, a next-generation anti-IgE antibody targeting food allergy and other atopic diseases. The company has raised $95 million to date, including a $45 million Series A extension. Phase 1 data are expected in the second half of this year. With an estimated 7 million high-risk food allergy patients in the U.S., Poplar is betting that IgE still has room for reinvention.

👩‍🔬 March 5, 1938 — Lynn Margulis Is Born.
The evolutionary biologist championed the theory that mitochondria and chloroplasts were once free-living bacteria that merged with early cells. Her ideas were rejected by roughly fifteen journals before publication. Today, endosymbiosis is textbook biology. Sometimes the boldest ideas just need better reviewers.

Every workplace needs that one person willing to say what everyone else is thinking out loud.

This week, that was Bourla.

You might not want him running your group chat. But you probably want someone like him in your meeting when things start drifting.

That’s all for today. See you Tuesday for the next issue. 👋

And if you are going to call out leadership, at least bring data to the mic. 🎤

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