Original reporting and analysis on the stories shaping biotech.
China's new supply chain regulations took effect with zero warning, making it potentially illegal for Western pharma companies to diversify away from Chinese manufacturing. With China controlling 40-45% of global API production, the industry faces an impossible compliance puzzle between Washington and Beijing.
Bayer is paying up to $2.4 billion for a tiny eye implant that showed something unprecedented in trials: it actually reversed glaucoma damage instead of just slowing it down. The deal reveals how desperate big pharma is to escape the biosimilar squeeze.
CellCentric just raised $220 million (oversubscribed) for a single oral cancer drug that works through epigenetics, not immunotherapy. With investors like Fidelity and RA Capital fighting to get in, the Cambridge spin-out is betting it can crack multiple myeloma after everything else fails.
Novo Nordisk killed its simpler pen design for CagriSema but swears the launch timeline hasn't budged. In the middle of the fiercest obesity drug race in history, that tradeoff might be the smartest move they've made all year.
BioNTech is shuttering four manufacturing sites and cutting 1,860 jobs as it dismantles its COVID vaccine empire. The company is betting everything on becoming an oncology powerhouse by 2030, armed with €16.8 billion in cash and 15 Phase III cancer trials.
GSK just dropped $55 million (with up to $1 billion on the table) to license a Chinese biotech's RNA drug that targets belly fat while preserving muscle. It's the latest sign that the obesity drug race is about to get way more interesting than GLP-1s.
Madrigal Pharmaceuticals just paid up to $1 billion for a gene-silencing drug to pair with its blockbuster MASH therapy Rezdiffra. It's the third major deal in a year as the company races to build an unbeatable liver disease franchise before Novo Nordisk and others crash the party.
The FDA is letting Amgen and AstraZeneca share live clinical trial data with regulators as patients enroll, not after trials end. It could cut drug development timelines by 20-40%, and it's the biggest change to how trials work in six decades.
Gene therapy keeps failing Huntington's patients, and Latus Bio thinks it knows why: everyone's been using way too much drug. Their $97 million Series A is funding a radically different delivery approach that could change the math for brain diseases.
Cytokinetics just dropped new MYQORZO data at ACC that beat both placebo and metoprolol across every major measure in 371 HCM patients. With Camzyos' non-obstructive trial already failed, the second-mover might be building the better mousetrap.
Viridian's elegrobart just posted another Phase 3 win in thyroid eye disease, threatening Amgen's $1.9 billion Tepezza monopoly. The twist: it's a self-administered shot versus Tepezza's eight IV infusions, and the chronic TED data is right around the corner.
Passage Bio is cutting 75% of its workforce after the FDA demanded a randomized trial it can't afford to run. The gene therapy company's promising brain data wasn't enough to overcome the brutal economics of rare disease drug development.
Twenty-one biotech companies just launched a brand-new trade alliance, and it's not trying to be the next BIO. With the FDA in chaos, pricing threats mounting, and China closing the gap, the American Biotech Innovation Alliance wants to build a national strategy before it's too late.
Odyssey Therapeutics withdrew its IPO last year. Now it's back asking for $236.6 million, more than double its original target, after burning through $750 million in venture capital without a single approved drug. The 2026 IPO window might be just crazy enough to say yes.
Celcuity's gedatolisib just went two-for-two in Phase 3, proving it works in breast cancer patients regardless of a key genetic mutation. With an FDA decision weeks away and blockbuster ASCO data incoming, this could reshape second-line treatment for the most common form of breast cancer.
The Trump administration went from blocking a psychedelics company's FDA voucher to signing an executive order calling these drugs "life-saving," all in about 60 days. Three companies just got golden tickets that could slash their FDA review from 10 months to under two.
Intellia just posted Phase 3 results for the first CRISPR therapy designed to edit genes inside a living patient. One injection, 87% fewer attacks, and an FDA submission already underway. The gene editing revolution might finally have its breakthrough product.
UCB is paying $2.2 billion for a company that didn't exist publicly until 18 months ago. Candid Therapeutics' T-cell engagers put UCB on a collision course with Gilead in biotech's most competitive arms race: autoimmune disease.
A tiny Minneapolis diagnostics company paid $10 million for a drug Pfizer didn't want. Four years later, it just beat Novartis's Piqray in a head-to-head Phase 3 breast cancer trial, and the implications are enormous.
Esperion Therapeutics is leaving Nasdaq after a decade-long stock collapse, even as its cholesterol drugs post triple-digit revenue growth. Healthcare PE firm ARCHIMED is paying a 58% premium in a deal worth up to $1.1 billion, and the reasons why say a lot about what's broken in small-cap biotech.
Gilead Sciences is unwinding its once-massive oncology alliance with Arcus Biosciences after key lung cancer trials hit a futility wall. With over a billion dollars already invested and a string of recent acquisitions reshaping its cancer strategy, this breakup says as much about where oncology is heading as where it's been.
Merck just committed up to $1 billion over a decade to blanket its entire 75,000-person organization in Google's agentic AI. It's the largest operational AI rollout in pharma history, and it signals that the industry's flirtation with artificial intelligence has become a full commitment.
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