Past Issues
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The FDA just said gene therapies for 12 patients don't need trials built for 12 million
The FDA dropped a framework that could fundamentally rewire the economics of ultra-rare gene therapy, and it's the kind of regulatory shift that doesn't come around often. Meanwhile, Regeneron finally crashed the radiopharma party, Lilly bet $202 million on making viruses obsolete, and a migraine startup raised $290 million without testing a single drug in humans.
Europe just greenlit a Wegovy you can swallow
A needle-free version of the world's most famous weight-loss drug just cleared a major regulatory hurdle in Europe, and it's not the only approval making waves this week. From a cancer vaccine cracking one of oncology's toughest codes to the first new blood pressure mechanism in over a decade, today's issue is stacked.
A weekly shot just matched bariatric surgery. The obesity race has a new king.
Eli Lilly dropped Phase 3 data so good it makes gastric bypass look like the hard way. Meanwhile, Google's AI drug lab just raised more than most biotechs are worth, and a Chinese-made guided missile just supercharged the best-selling cancer drug on Earth.
A pig kidney kept a man alive for 271 days. Now the FDA wants more.
A gene-edited pig kidney just set a durability record that could reshape transplant medicine for 90,000 Americans on the waitlist. Meanwhile, pharma is pouring hundreds of billions into U.S. factories, UCB dropped $2 billion on a company that didn't exist two years ago, and an algorithm went shopping for a cancer drug.
Pharma lost 16 straight courts. The Supreme Court just made it 17.
The drug industry's three-year legal crusade against Medicare price negotiation is officially dead, and the strategic fallout is just beginning. Meanwhile, a pig kidney kept a man alive for nine months, and a biotech timed its IPO with the precision of a Hollywood press tour.
U.S. biotech signed $18.3B in Chinese drug deals. Now the industry is at war.
The American biotech industry is in the middle of a full-blown identity crisis over China, and the numbers behind the tension are jaw-dropping. Plus: a drug target left for dead gets a second life, two companies race to cure a decades-old disease, and a biotech sells itself for seven cents on the dollar.
Regeneron's melanoma miss reshapes its strategy. Then it went shopping.
Regeneron had quite a week: its biggest cancer trial failed by a heartbreaking statistical margin, and on the same day it dropped $2.3 billion on a technology that doesn't have a single clinical candidate yet. Meanwhile, the FDA flip-flopped on Moderna's flu vaccine, an AI-designed drug actually worked in humans, and a 107-year-old Italian family just made the wildest bet in its history.
Regeneron paid $40M for a seat at biotech's $4.3B radiopharma table
Regeneron just entered the radiopharmaceutical arms race with one of the most cleverly structured deals in recent memory, putting down $40 million on a partnership worth up to $4.3 billion. Meanwhile, the White House is reshaping biotech from every angle: triple-digit tariffs on foreign-made drugs, a 15-year leash on Lilly's new diet pill, and magic mushrooms as federal healthcare policy.
The FDA just approved a drug that picks the lock cancer uses to cheat death
A new blood cancer drug just became the first BCL-2 inhibitor approved for mantle cell lymphoma, offering a take-home pill for patients who've burned through every other option. Meanwhile, U.S. biotechs are quietly packing their clinical trials and shipping them overseas, and Biogen is charging into Phase 3 with an Alzheimer's drug that technically failed its big test.
$2.1B for a company with one drug just cleared for trials. Here's why investors are still impressed.
Alphabet's AI drug lab just raised more money than most biotechs are worth, on the strength of a single FDA clearance and no clinical data yet. Meanwhile, U.S. companies are quietly shipping their early trials overseas because the FDA can't keep the lights on. It's a weird moment for American biotech dominance.
BMS just bet $15B on a Chinese drugmaker you've never heard of
Bristol Myers Squibb committed up to $15.2 billion to license 13 preclinical programs from China's Hengrui Pharma, right as Washington tries to decouple from Chinese biotech. Meanwhile, a Zuckerberg-backed startup rescued a Parkinson's cell therapy from the dead, and the first-ever protein-destroying cancer drug just hit the market.
Biotech stocks are rallying because the FDA chief might get fired
The industry that's supposed to hate regulatory uncertainty is cheering the potential ouster of its top regulator. That tells you everything about how the last 14 months went. Plus: a gene therapy that killed four kids is back in the clinic, and Amgen bets big on a computer that doesn't fully exist yet.
The FDA just lost its third commissioner in three years
The White House has signed off on a plan to oust FDA Commissioner Marty Makary after just 14 months, though the move has not yet been executed. Meanwhile, two biotechs raised $556 million in back-to-back IPOs, and a mouse study suggests your liver might hold the key to treating Alzheimer's.
Three biotech buyouts in one week totaled $5.75 billion. Here's what snapped.
Something broke in biotech M&A this week, and by "broke" we mean the deal counter. Three acquisitions landed in a single week, totaling approximately $5.75 billion. Meanwhile, a biotech IPO rose from the dead, Blackstone bet $250 million on fewer pills, and IL-2 programs continue to struggle toward commercial success.
Sanofi walked away from the FDA's fastest approval lane. Here's why.
A pharma giant voluntarily ditched the FDA's express-checkout program after a political appointee allegedly opposed career scientists' recommendations. Meanwhile, the agency is simultaneously trying to modernize clinical trials with real-time data streaming. The contradictions at the FDA right now are something else.
The FDA just torched 60 years of clinical trial protocol
The FDA is letting drugmakers share live trial data with regulators as patients enroll, not after studies end. It's the most radical change to how drugs get developed since the 1960s. Meanwhile, China quietly made it illegal for pharma companies to leave its supply chain, and the M&A machine keeps roaring.
The FDA letter that killed a company (and left 6 people standing)
A gene therapy company just went from 24 employees to six after the FDA demanded a trial it couldn't afford. Meanwhile, the rest of biotech is having a very different week: blockbuster Phase 3 wins, a $237M IPO attempt, and a radical new bet on Huntington's disease.
A $10M Pfizer castoff just beat Novartis in a head-to-head cancer trial
A tiny diagnostics company bought a drug Pfizer shelved for $10 million, then used it to defeat one of Novartis's flagship oncology products in a direct Phase 3 comparison. Meanwhile, the White House did something nobody predicted: it went all-in on psychedelics.
Merck just wrote a $1B check to Google. The reason is wild.
Merck is betting a billion dollars that Google's AI can fix drug discovery, and it's the largest operational AI rollout pharma has ever seen. Meanwhile, a billion-dollar oncology alliance is crumbling, and one biotech is ghosting Wall Street entirely.
The first drug that eats a cancer protein just got FDA approval
The FDA just greenlit an entirely new class of cancer medicine, a month ahead of schedule. Meanwhile, two biotech IPOs priced in a single day, the FDA's biologics gatekeeper walked out (again), and a $5 billion bet on dethroning Keytruda hit a wall.
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