Past Issues
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$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.
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.
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