👋 Hey, let’s get into it. The FDA is officially done politely asking pharma companies to clean up their ads.

After a wave of warning letters to companies like Eli Lilly, Novartis, and Bristol Myers Squibb, the agency is now going a step further, asking Congress for real enforcement power. The goal is simple. If a drug ad is misleading, the FDA wants the authority to call it what it is: misbranding.

This comes after last year’s push to make sure direct-to-consumer ads actually present a balanced view of risks and benefits. Apparently, “may cause sudden death” buried in size 6 font is no longer cutting it.

Meanwhile, supplement companies are still out here selling magic beans with a free bottle of snake oil if you act fast.

We go deeper into the FDA’s latest power grab, including faster trial pathways and transparency pushes, in today’s Deep Dive.

💰 Gilead Drops $3.15B on Tubulis
Gilead is continuing its acquisition spree, scooping up ADC biotech Tubulis for $3.15 billion upfront with up to $1.85 billion in milestones. The deal adds a next-gen antibody-drug conjugate platform and a lead candidate heading toward pivotal trials. This marks Gilead’s third major deal in six weeks, following Arcellx and Ouro Medicines, as CEO Daniel O’Day aggressively rebuilds the company’s oncology pipeline. After years of slower dealmaking, Gilead is now firmly back in buy mode, though management says it may finally pause to digest.

🤺 Novavax Shareholder Revolt Heats Up
One of Novavax’s largest shareholders is going straight for the jugular, calling out CEO John Jacobs for “destruction of shareholder value” and planning to vote against his pay package. Despite partnerships with Sanofi and Pfizer, the company’s stock has cratered 95% over five years, and its COVID vaccine is barely gaining traction. The activist investor is pushing for aggressive cost cuts, leadership reductions, and a full strategic overhaul. Translation: even good science cannot save you from bad execution forever.

🤝 Shionogi Lands $119M BARDA Deal for Antibiotic
Shionogi secured an initial $119 million contract from BARDA to build a U.S. manufacturing site for its antibiotic Fetroja. The deal could expand to $482 million and positions the drug as a key defense against drug-resistant infections and biothreat pathogens. It is the latest example of governments prioritizing domestic manufacturing, especially for critical medicines tied to national security. Antibiotics may not be flashy, but when things go sideways, they suddenly become very important.

💉 Merck’s Vaccine Demand Collapse in China
Merck is ditching fixed purchase commitments for its Gardasil vaccine in China after demand collapsed. Its partner Zhifei saw procurement drop from 34.8 billion yuan in 2023 to under 2.2 billion last year. The companies are now shifting to a demand-based model, signaling a major reset in expectations. It is a reminder that even blockbuster vaccines are not immune to shifting market dynamics, especially in complex international markets.

🧠 Lilly Expands Alzheimer’s Pact
Lilly paid $12.5 million upfront to expand its Alzheimer’s collaboration with AC Immune as a tau-targeting candidate moves closer to clinical testing.

💰 Merck Lowered Terns Bid
Merck cut roughly $1 billion from its Terns acquisition offer after underwhelming leukemia data, dropping its bid from $61 to $50 per share.

💸 Vertex Taps Halozyme Tech
Vertex will pay $15 million upfront to use Halozyme’s drug delivery platform, aiming to enable smaller injections and more at-home treatments.

🌍 Jeito Closes $1.2B Biopharma Fund
Jeito Capital raised $1.2 billion for its second fund, marking the largest independent European biopharma-focused investment fund to date.

🤝 Akari Partners With WuXi
Akari Therapeutics teamed up with WuXi XDC to accelerate development and manufacturing of its RNA-splicing ADC cancer therapy.

🫁 Sanofi Immune Drug Shows Mixed Results
Sanofi’s bispecific drug succeeded in asthma and nasal polyps trials but failed to hit endpoints in eczema, creating a mixed clinical picture.

❌ Insmed Scraps Brinsupri
Insmed is discontinuing its Brinsupri program after a second failed mid-stage trial, ending hopes for expansion into additional indications.

One year into his tenure, FDA Commissioner Marty Makary is not asking for small tweaks. He is asking for a full system upgrade.

At the center of the proposal is a new clinical trial pathway designed to move faster than the traditional IND process. The idea is simple. If you already have strong preclinical data, especially using modern non-animal methods, why wait nearly a year to start a Phase 1 trial? The FDA wants a faster, risk-based option to get those studies moving.

And there is a bigger reason behind the urgency. China is moving faster. A lot faster. Makary pointed out that China is initiating significantly more early-stage trials, fueled by streamlined processes and alternative pathways like investigator-initiated trials. The U.S., meanwhile, is getting stuck in regulatory and institutional bottlenecks.

But speed is only half the story.

The FDA is also pushing for what it calls “radical transparency.” That includes publishing more details from complete response letters so companies can learn from each other’s failures instead of repeating them. It is a subtle but meaningful shift from closed-door feedback to something closer to shared industry learning.

Then there is enforcement. The agency wants stronger authority to crack down on misleading drug ads, require clearer supply chain disclosures, and even pull products if manufacturing data is incomplete. That ties directly back to the opener, where the FDA is clearly tired of playing referee without a whistle.

On top of that, the proposal touches everything from boosting domestic generic manufacturing to simplifying biosimilar adoption by removing the confusing “interchangeability” label altogether.

Big picture, this is not just a policy update. It is the FDA trying to reposition itself for a world where speed, transparency, and global competition matter more than ever.

That is the projected 2026 revenue for AI-powered telehealth startup Medvi, which reportedly operates with just two employees. The company built its platform using AI tools, but red flags are piling up, including lawsuits, fake testimonials, and an FDA warning over misleading claims. The one-person unicorn era might be here, but so are the compliance headaches.

Here’s what biotech Redditors are talking about:

👎 Private Equity Playbook Hits Again
One Reddit user shared how their company shrank from nearly 500 employees to under 100 after a private equity acquisition. Others piled on, describing a familiar pattern of asset stripping, layoffs, and leadership cash-outs. The harsh consensus: PE is not here to operate your company, it is here to extract value, and employees are rarely part of that equation.

😬 PIP = Paid Interview Period?
A biotech professional facing a Performance Improvement Plan (PIP) turned to Reddit for advice, already assuming the outcome was inevitable. The response was blunt: start job hunting immediately, because most PIPs are designed to document an exit, not prevent one. The more strategic take was to control the narrative early and leave on your own terms before the paperwork defines it for you.

🤑 Amgen CEO Pay Climbs
Amgen CEO Robert Bradway earned $24.7 million in 2025, bringing the company’s CEO pay ratio to roughly 160 to 1.

🍟 Healthy Fries Are Here
Researchers (yes, actual scientists) developed a hybrid frying method using microwaves that keeps fries crispy with less oil, quietly attacking GLP-1 demand.

🤖 Fortrea Launches AI Trial Suite
Fortrea unveiled an AI-powered platform designed to streamline clinical trials, improve predictability, and automate operational workflows.

📺 Omnipod Lands in Scrubs
Insulet’s Omnipod insulin device made a cameo in the Scrubs revival, blending diabetes care with primetime product placement.

🎯 Stipple Bio Raises $100M to Target Cancer More Precisely
Stipple Bio emerged from stealth with a $100 million Series A to advance its precision oncology pipeline. Its lead ADC, STP-100, uses a proprietary platform to identify tumor-specific epitopes, aiming to avoid the toxicity issues that plague many cancer therapies. With clinical entry expected next year and funding through 2029, the company is betting that better targeting can unlock safer, more effective treatments.

💻 April 9, 1919 — The Birth of a Computing Pioneer
J. Presper Eckert, co-inventor of ENIAC, was born on this day. ENIAC became the first general-purpose electronic digital computer, capable of solving complex numerical problems at unprecedented speed. It filled entire rooms, used 18,000 vacuum tubes, and consumed massive power, but it laid the foundation for modern computing. Every biotech model, AI tool, and simulation today traces back to machines like this.

The FDA rolled out a 91-page plan pushing for faster trials, better data, and less misleading advertising. Pharma companies are already sweating the fine print.

Meanwhile, somewhere, a supplement company just slapped “clinically inspired” on the bottle and called it a day.

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

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