Past Issues
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J&J shelved a CAR-T therapy that was working. Here's why.
A therapy with 100% response rates just got shelved because the spreadsheet said no. Today's newsletter is a masterclass in why great science doesn't always equal great business, plus an FDA panel that told AstraZeneca to stop trusting smoke detectors, and a pill that might finally get needle-phobic patients off the GLP-1 sidelines.
Chiesi drops $1.9B on the idea that HAE patients hate needles
A pill that replaces a panic-inducing injection just fetched nearly $2 billion. From a $700M Alzheimer's partnership that produced zero drugs to a $2 billion bet on a molecule that hasn't touched a human, pharma's checkbooks are wide open and the bets are getting bolder.
The FDA wants to watch your clinical trial live. Here's what that means.
The FDA just went from reading the box score to streaming the game. Its new real-time trial monitoring system is already live with AstraZeneca, and a broader pilot launches this summer. Meanwhile, a $700M bet on Tourette syndrome, two AstraZeneca cancer drugs hitting a regulatory wall, and a biotech stock that dropped 47% on "home run" data.
The obesity drug ingredient that scared pharma for 40 years just hit Phase 3
A hormone that killed every obesity program it touched for four decades just posted results nobody expected. Meanwhile, India's largest generics company wrote an $11.75 billion check for a struggling Merck spinoff Wall Street had priced for dead, and Eli Lilly keeps spending billions on gene editors that don't exist in nature.
Lilly just paid $2.3B for a drug with zero human data. Here's why.
Eli Lilly wrote a massive check for a preclinical blood cancer drug, Intellia is sprinting toward the first-ever in vivo CRISPR filing, and big pharma collectively dropped over $12 billion on deals this month. Oh, and Lilly's new obesity pill got 1,390 prescriptions in week one. Wall Street had feelings about that.
The FDA just killed the coverage wait that was blocking breakthrough devices
The FDA and CMS finally decided to start talking to each other, and the result could shave years off the gap between approving a breakthrough medical device and actually getting Medicare to pay for it. Meanwhile, Roche wants to replace your MS infusion with a pill, Big Pharma is hoarding GPUs like they're gold bars, and the FDA is reopening the door for compounding pharmacies.
The FDA handed psychedelics a golden ticket. Six days after the White House said so.
The president signed an executive order on a Friday, and by the following Thursday the FDA had already handed priority review vouchers to three psychedelic therapy developers. Meanwhile, Wall Street is throwing money at biotech IPOs like it's 2021 again, and someone just agreed to spend up to $1.1 billion on factories.
Regeneron just cured a type of deafness with a single surgery
A major antibody company just pulled off its first gene therapy approval, and it restores hearing in babies born deaf. Meanwhile, Regeneron also became the last major drugmaker to sign a White House pricing deal, a biotech wants $200M to prove you've been taking your lung drugs wrong, and one CEO barely lasted long enough to learn where the coffee machine was.
A drug just nearly doubled survival in pancreatic cancer's worst odds
A KRAS-targeting drug posted first-line pancreatic cancer data that made the entire oncology world lean in. Meanwhile, Lilly can't stop buying things, Merck wrote Google a billion-dollar check, and a gene therapy is making deaf patients hear whispers.
52% tumor response: the "undruggable" cancer target just got drugged
For 40 years, KRAS was the protein oncologists couldn't touch. Revolution Medicines just posted data that nearly triples chemotherapy's benchmark, and the FDA already has it in the express lane. Plus: a two-drug HIV pill that came back from the dead, and $281 million in fresh bets on brains, blindness, and modified DNA.
Lilly just dropped $7B to build cancer treatment inside your body
Eli Lilly wrote another enormous check for a technology that could turn CAR-T therapy from a weeks-long manufacturing nightmare into a single IV drip. Meanwhile, the TIGIT graveyard claimed another victim, and a cancer-fighting virus company is fighting for survival after its second FDA rejection.
The drug target everyone abandoned just won its third Phase 3 trial
AstraZeneca just proved the entire industry wrong on a target that Roche and Sanofi couldn't crack. Meanwhile, Novo Nordisk quietly became a sickle cell disease company, and a rejected biotech is knocking on Wall Street's door again.
Lilly's obesity pill grabbed 1,400 scripts before pharmacies even stocked it
A weight-loss pill just posted opening-weekend numbers that would make a Marvel movie jealous, and it wasn't even available at most pharmacies yet. Meanwhile, the FDA managed to reject the same cancer drug twice and quietly unbanned a dozen peptides it called dangerous two years ago.
UCB bets $1.15B that transplanted brain cells can cure epilepsy
A Belgian pharma giant just paid over a billion dollars for a therapy that transplants lab-grown neurons into patients' brains, and the early data is wild. Meanwhile, OpenAI launched its first biology-specific AI model, Merck revealed its post-Keytruda survival plan, and a cancer drug that wears a molecular disguise just entered the clinic.
A pancreatic cancer drug just nearly doubled survival. Oncologists are stunned.
Revolution Medicines dropped Phase 3 data that almost no one thought was possible: a pill that nearly doubled survival in pancreatic cancer, the deadliest major malignancy in oncology. Meanwhile, a two-year-old company you've never heard of just pulled off the biggest biotech IPO in history, and a new report is calling Alzheimer's blockbuster drugs a bust.
A daily pill just doubled pancreatic cancer survival. Oncology is stunned.
A cancer that kills 97% of patients with metastatic disease just met a pill that nearly doubled survival times, cracking a target scientists called "undruggable" for four decades. Meanwhile, Big Pharma is handing AI companies the keys to the drug lab, and the FDA is cleaning house on compounded peptides.
A senator bet his life on an "undruggable" cancer drug. The data just landed.
A former U.S. senator enrolled in a trial for a drug that scientists said couldn't exist, and Phase 3 results show pancreatic cancer patients living nearly twice as long as those on chemo. Meanwhile, the FDA just sent 2,200 companies a not-so-friendly reminder about their missing trial data.
Lilly just paid $300M for a company with zero drugs in humans
Eli Lilly dropped up to $300 million on a two-year-old startup that hasn't tested a single drug in people. Meanwhile, AbbVie is shopping for painkillers in China, two obesity and proteomics companies want nearly $700M combined from public markets, and Big Pharma quietly took out the immunology trash.
The protein that stumped cancer researchers for 40 years just lost a fight
A cancer target that scientists literally gave up on just got beaten in a Phase 3 trial, with results so strong they might reshape oncology's most stubborn tumor types. Plus: the FDA fast-tracks a guided-missile drug for the deadliest lung cancer, Regeneron crashes the radioactive drug party, and two biotechs ring the IPO bell on the same day.
Western pharma went on a China biotech shopping spree to start 2026
Big Pharma is buying Chinese biotech innovation at a pace that would make Black Friday shoppers blush, pouring billions into licensing deals before most people finished their New Year's resolutions. Meanwhile, Gilead announced $13 billion in deals in six weeks, the FDA blessed a needle-free weight loss pill, and biotech's IPO window is officially back open.
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