Past Issues
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A disease with zero treatments for 77 years just got its first
The FDA just approved the first-ever drug for a brain disease that has gone untreated since it was discovered in 1949. Meanwhile, the world's best-selling cancer drug lost a head-to-head survival fight to a Chinese biotech's challenger, and three patient deaths forced Novartis to pump the brakes on one of medicine's most hyped frontiers.
The drug that just beat Keytruda in an overall survival showdown
A bispecific antibody out of China just did what no other drug has done: beat Keytruda head-to-head in overall survival for first-line lung cancer. With $30 billion in annual revenue on the line, Merck's biggest franchise suddenly looks mortal. Meanwhile, a devastating Phase 3 failure crushes hopes for Angelman syndrome families, the FDA reverses course on a Huntington's gene therapy, and CRISPR's delivery problem claims more lives.
Novartis just found a blockbuster MS drug that turns down your immune system's thermostat
Novartis dropped Phase 3 data so strong that analysts are throwing around multi-billion-dollar peak sales estimates, and it did it by rethinking how we fight multiple sclerosis entirely. Meanwhile, an mRNA cancer vaccine quietly failed in a way that's worse than it sounds, and a phage therapy company decided it would rather work for the Department of Defense.
Three deaths just froze the most hyped frontier in cell therapy
CAR-T therapy promised to "reset" the immune system and cure autoimmune diseases. Then three patients died, and two pharma giants hit the brakes on the same technology in the same month. Meanwhile, AstraZeneca found a new sidekick for its $7 billion cancer drug, and the FDA commissioner allegedly tried to kill a drug approval before his own scientists stopped him.
A landmark blood cancer drug just crushed its trial 7-to-1
A drug approval nearly three decades in the making, a $2.88 billion bet on teaching your body to eat its own antibodies, and an AI that just designed 1,320 proteins (most of them actually worked). Today's issue is stacked.
Sarepta's $900M gene therapy just got the FDA's scariest warning label
A near-billion-dollar gene therapy franchise picked up a black box warning for fatal liver failure the same week its maker cut 500 jobs. Somehow the stock went up. Meanwhile, a disease that has stolen teenagers' vision for decades might finally have its first treatment, and Bayer figured out how to photograph the heart disease that hides from every doctor who looks for it.
A cancer vaccine made patients worse, not better. Now what?
A personalized mRNA cancer vaccine was supposed to prevent tumors from coming back. Instead, an independent review found a numerical imbalance in overall survival favoring the control group, and the trial is dead. Meanwhile, the same week brought a first-in-class FDA approval, a massive debt raise, and gene-editing data that sound like science fiction.
A pill just doubled survival in pancreatic cancer. Wall Street sees billions.
The FDA approved a drug that nearly doubled survival in metastatic pancreatic cancer, a disease that has humbled the entire pharmaceutical industry for decades. Meanwhile, a gene-editing therapy just destroyed hepatitis B's hidden DNA reservoir in a living patient for the first time, and billions of dollars in deals are reshaping oncology, inflammation, and epilepsy.
Vertex just wrote a $10B check to escape its own success
Vertex dropped its biggest acquisition ever to prove it's more than a cystic fibrosis company, the FDA approved two firsts (a trastuzumab killer and a drug for a disease that literally had zero treatments), and a prominent biotech investor got caught peeking at Yale's homework. It's a packed one.
This disease had zero treatments for decades. Now it has one.
A rare blood disease just got its first-ever FDA-approved therapy, and it signals something much bigger about the antibody drug arms race. Meanwhile, a $20 blood draw is coming for the $5,000 Alzheimer's brain scan, Japan greenlit what might be the first functional cure for hepatitis B, and Lady Gaga launched a biotech startup. Yes, really.
A cancer vaccine built from your own tumor just passed its biggest test
Moderna and Merck just proved that a vaccine custom-built from a patient's own tumor mutations can beat cancer in a pivotal trial. Meanwhile, big pharma dropped billions chasing factory-free cell therapies and muscle-sparing weight-loss drugs, and a heart startup convinced Wall Street to hand over $440 million.
Moderna's cancer vaccine just added $45B in market cap. In one day.
An mRNA vaccine that doesn't target a virus just delivered the first positive Phase 3 result in cancer vaccine history, and it sent Moderna's stock on its wildest ride since the pandemic. Meanwhile, Eli Lilly went on a $4.5 billion shopping spree across psychedelics and pen factories, and the FDA commissioner allegedly tried to personally kill a rare disease drug.
Sarepta's $900M drug just earned the FDA's scariest label
Two boys died after receiving a gene therapy that generated nearly $900 million in revenue last year. Now Sarepta is slashing a third of its workforce, the FDA slapped on a black box warning, and the gene therapy field is confronting its most uncomfortable question yet. Plus: a $2.2 billion brain-drug merger, a Polish company that just matched Ozempic, and the $2 billion biotech factory shutting half its lights off.
Every pharma company lost its IRA lawsuit. Then Teva got a second chance.
The Inflation Reduction Act's drug pricing program looked legally invincible, with every pharma challenger getting swatted down in court. Then a federal appeals court cracked the door open for Teva, and the entire industry is paying attention. Plus: a $2.7 million gene therapy replaces a lifetime of eating cornstarch, and Novo's $149 pill could upend the GLP-1 war.
The disease that turns muscle into bone just got a new drug
The FDA just approved a new treatment for a condition that literally builds a second skeleton around your body, and the story of how it got there involves five patient deaths, a decade of development, and a mechanism that could matter far beyond 834 people. Plus: Trump's FDA pick has never run a regulatory agency, an LSD pill aces a Phase 3 anxiety trial, and mini-brains survived five years in a dish.
A personalized cancer vaccine just posted landmark Phase 2b results — and Phase 3 is underway
A personalized cancer vaccine posted striking Phase 2b efficacy data that held up at five years, and a pivotal Phase 3 trial is now fully enrolled. Meanwhile, Eli Lilly dropped $2.4 billion on a circle, CSL posted a $2.6 billion loss and its stock soared 18%, and the FDA essentially asked the internet how to regulate AI doctors.
A dead biotech just became a migraine startup's $245M ride to Nasdaq
When biotech's front door is jammed shut, companies find creative side entrances. Today's top story is a masterclass in second lives: a gutted public shell, a migraine startup, and eight heavyweight investors who just piled a quarter-billion dollars into what might be the deal structure of the year. Plus, a cancer-killing virus gets FDA approval, and the company everyone counted out just dropped blockbuster data.
The FDA just cleared a therapy that builds cancer-killing cells inside your body
A circular RNA startup just got the green light to test a drug that turns your own T cells into disease fighters without ever leaving your bloodstream. Meanwhile, AstraZeneca's big bispecific bet flopped, Lilly went shopping for drug targets nobody else wanted, and $9.1 billion in VC funding somehow left most biotech startups empty-handed.
Europe yanked Amgen's drug off shelves, not for safety, but for cheating
European regulators just pulled an approved drug from the market because the pivotal trial behind it was rigged after the fact. It's one of the rarest regulatory actions ever taken against a major pharma company, and it's not the only story testing trust in the system today. From a $15 billion China deal to an FDA commissioner allegedly trying to kill a drug himself, it's a wild one.
The first mRNA vaccine outside COVID just got approved (and it's not RSV)
Moderna just proved that mRNA isn't a pandemic-only trick, landing FDA approval for the first-ever mRNA flu vaccine. Meanwhile, a drug that tackles narcolepsy at its root cause has an ironic side effect, and a 40-year-old biotech just shut down its own lab on purpose.
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