Original reporting and analysis on the stories shaping biotech.
Valneva pulled the world's only approved chikungunya vaccine from the U.S. after it was found to cause the very disease it was supposed to prevent. With the virus spreading northward and no replacement on American shelves, the withdrawal exposes a gaping hole in tropical disease preparedness.
Fate Therapeutics' off-the-shelf CAR-T therapy showed clean safety and improved symptoms in all four systemic sclerosis patients treated so far. It's the latest sign that cancer's most powerful weapon might have a second career in autoimmune disease.
Moderna just launched the world's first Phase 3 trial of an mRNA bird flu vaccine, right as H5N1 creeps closer to becoming a human problem. But the U.S. government already pulled $766 million in funding, so who's actually paying for this pandemic insurance policy?
Moderna just scored EU approval for the world's first combined flu-COVID vaccine, beating every competitor to the punch. The single-shot approach outperformed getting both vaccines separately, and it could reshape how hundreds of millions of people vaccinate each fall.
BMS's precision combo of Krazati plus cetuximab shrank colorectal tumors at nearly three times the rate of chemotherapy, yet patients didn't live a single day longer. The confirmatory trial failure threatens an accelerated approval and raises hard questions about targeted therapy's limits in GI cancers.
Samsung Bioepis just posted the first-ever Phase 3 data for a Keytruda copycat, and it matched the $32 billion original on every measure. With at least ten companies racing to build biosimilar versions of the world's best-selling drug, the countdown to cheaper cancer immunotherapy has officially begun.
China just added semaglutide to its essential medicines list, making it the second GLP-1 drug prioritized for the world's largest diabetes population. With 233 million patients, expiring patents, and a wave of domestic competitors, the move could reshape the global GLP-1 market in ways Novo Nordisk and Eli Lilly didn't plan for.
Four adult Duchenne patients showed less fat in their muscles after six months on Satellos' experimental drug, reversing a trajectory that was supposed to be a one-way street. The data are tiny but the implications are massive.
Trump's new tax bill restores immediate R&D expensing for biotech, but Medicaid cuts, tariffs, and MFN pricing could quietly erode the industry's revenue outlook. The fine print tells a very different story than the headline.
AstraZeneca just dropped $200 million (with up to $2.1 billion more on the line) to license a COPD drug from China's Sino Biopharmaceutical that could challenge Merck's fast-growing Ohtuvayre. The dual PDE3/4 inhibitor TQC3721 posted impressive Phase 2 data, and the race for next-gen COPD treatments is officially on.
Sino Biopharmaceutical is acquiring LaNova Medicines for up to $951 million, but the real story is in the math: Merck already paid $588 million for just one of LaNova's drugs. The deal spotlights the red-hot bispecific antibody gold rush reshaping oncology dealmaking.
Congo's Ebola outbreak just jumped to two new provinces, pushing the death toll past 600. The terrifying catch: nearly every vaccine, drug, and rapid test in the global stockpile was built for the wrong strain of the virus.
The FDA hasn't had a permanent commissioner since May, and the White House is reviewing finalists to lead an agency that's lost 20% of its workforce. The choice will shape drug approval standards, AI-driven review pilots, and biotech valuations for years to come.
The NEJM just retracted the pivotal trial paper for Tavneos, a vasculitis drug with nearly half a billion in annual sales. The reason: patient data was secretly changed after the trial was unblinded, and nobody disclosed it.
GSK just terminated its $2.2 billion Alzheimer's partnership with Alector after both drugs flopped in clinical trials. The $700 million upfront payment is gone forever, and the wreckage tells us a lot about why the brain remains drug development's toughest frontier.
Prime Medicine just won a binding patent arbitration against Beam Therapeutics over a key gene-editing therapy, and the fallout could reshape who controls what across the entire CRISPR landscape. The ruling clears Prime's path to the clinic while exposing just how tangled gene-editing IP has become.
Pfizer's recall of Bicillin L-A has left the U.S. without reliable access to the only proven treatment for syphilis in pregnant women. With congenital syphilis cases up 700% since 2015, the timing couldn't be worse.
AstraZeneca's amyloidosis drug anselamimab just failed its Phase 3 trial. But the company claims a stunning subgroup signal: 62% survival improvement in a specific patient subset. Is this a real lifeline or the biotech equivalent of cherry-picking stats after a loss?
Novo Nordisk sued Hims & Hers over knockoff Wegovy. Now they're selling the real thing together on the Hims platform. The story behind pharma's strangest reconciliation, and why it could reshape how millions of Americans access GLP-1 drugs.
Intellia Therapeutics paused two late-stage CRISPR trials after a patient suffered life-threatening liver toxicity, and the fallout is forcing the entire in vivo gene-editing field to reckon with an uncomfortable question: how much risk is too much for a one-shot cure?
Ionis just expanded Tryngolza's FDA label from a rare disease affecting thousands to a condition hitting 2.3 million Americans, and the company now sees $3 billion in peak sales. It's the biggest bet yet in Ionis' transformation from biotech's favorite ghostwriter to a blockbuster drug company.
The FDA's drug review center has cycled through five directors in a year and lost over a thousand staff. With complex therapies flooding in and experienced reviewers flooding out, the agency that greenlights every new drug in America is facing a capacity crisis that could reshape the industry.
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