Original reporting and analysis on the stories shaping biotech.
The FDA just sent 30 warning letters to companies selling knockoff versions of Ozempic and other GLP-1 weight-loss drugs. With 605 adverse events, emergency room visits from contaminated products, and patients accidentally taking 20x their intended dose, the agency says the era of mass compounding is over.
Sanofi just committed up to $1.5 billion for a Chinese-developed blood cancer drug most people have never heard of. The deal says more about where Big Pharma is heading than any earnings call could.
Roche is pouring up to $520 million into South Korea, but not to build factories. The Swiss pharma giant wants to turn the country into its Asian clinical trial hub, and the reasons why reveal something bigger about where the drug industry is headed.
The FDA just released a draft guidance explaining how drugmakers can earn three years of generic-free protection for already-approved drugs. It's one of pharma's most powerful (and most confusing) tools, and the new rules finally make it readable.
Lonza sold its personalized medicine business back to the company that built it. Eight years after acquiring the Cocoon Platform from Octane Medical Group, the Swiss CDMO giant is handing back the keys, and the reasons say a lot about where biotech manufacturing is headed.
Eli Lilly has $1.5 billion in pills stockpiled and an April 10 FDA decision date for orforglipron, an oral obesity drug that could blow open a market where 98% of eligible patients still aren't being treated. The needle era might be ending sooner than you think.
A clinical trial tech company just dosed the first patient with a bispecific antibody designed to outperform Dupixent in asthma. Vial Health Technology's dual-target approach could reshape a $24 billion market, if Phase 1 data holds up.
A stealth startup just grabbed $50 million to turn cancer's most lethal weapon, T-cell engagers, against autoimmune disease. Prolium Bioscience is already dosing patients, and the race to repurpose oncology's bispecific antibodies is heating up fast.
Teva just secured $400 million from Blackstone without issuing a single share, using a royalty deal to fund a blockbuster IBD drug that could generate up to $5 billion in peak sales. It's the latest sign that royalty financing is reshaping how pharma funds its biggest bets.
Kyowa Kirin just killed its most promising eczema drug after cancer cases emerged in clinical trials. The culprit? A mechanism that was supposed to be its biggest advantage may have been disabling the body's cancer defenses all along.
For 30 years, chronic hepatitis B had no real cure, just lifelong pills. GSK and Ionis just dropped Phase 3 data for a six-month therapy that could change that for 254 million patients worldwide.
A Beijing biotech just raised $72.9 million to develop what could be the world's first once-monthly GLP-1 weight-loss shot. OrbiMed and Qiming Venture Partners are leading the bet, and the Phase III trial is already underway.
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AbbVie's Skyrizi just posted strong Phase 3 results in the Crohn's patients other drugs couldn't help, and the data could unlock a fully at-home treatment regimen. For a $17.5 billion franchise still accelerating, this might be the most important trial AbbVie ran all year.
The FDA told uniQure its promising Huntington's gene therapy needs a sham brain surgery trial before approval, torching the stock by 40%. The resulting ethical and regulatory showdown could reshape the future of every gene therapy that targets the brain.
The first human safety trial of a CRISPR-armed bacteriophage just landed in The Lancet Microbe, and the results are surprisingly clean. A Danish biotech armed bacteria-killing viruses with gene-editing scissors, and now they're headed for cancer patients next.
Bristol Myers Squibb's Sotyktu faces a March 6 FDA decision that could push the oral TYK2 inhibitor beyond psoriasis and into the crowded psoriatic arthritis market. The drug's unusual mechanism offers a cleaner safety profile than rival oral options, and BMS is betting that difference matters.
Biohaven slashed R&D spending by 60% after an FDA rejection, then reversed course months later to accelerate its molecular degrader programs. Promising early data showing 87% and 81% target protein reductions gave the company a reason to bet big again.
Theravance Biopharma just gutted half its workforce and killed its entire R&D operation after its lead drug failed Phase 3 for the second time. With $400 million in cash and no pipeline, the company is now a royalty stream looking for a buyer.
Oncolytics Biotech is betting that a modified cold virus can crack the toughest problem in colorectal cancer: the 95% of patients that immunotherapy can't help. Early data looks wild, and a new randomized trial just launched to prove it.
A little-known Chinese biotech just posted Phase III eczema data with near-perfect statistical significance across every endpoint. In a market heading toward $30+ billion, zemprocitinib's oral convenience and clean safety profile could shake up Dupixent's reign.
Generate Biomedicines raised $400 million in the biggest biotech IPO since 2024, then watched its stock crater 21% on day one. In a red-hot IPO market where February debuts averaged 41% first-day gains, this AI drug company's faceplant is sending a loud message about what investors really think of AI biotech hype.
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