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Amgen's Drug Got Pulled Off the Market for Cheating, Not for Being Dangerous
The European Commission revoked Amgen's Tavneos after the EMA declared the pivotal trial data unreliable due to data integrity and Good Clinical Practice breaches that rendered the data incorrect and misleading, meaning the benefits could no longer be shown to outweigh the risks. Unblinded personnel reviewed efficacy results, re-adjudicated nine patients' outcomes, and flipped the primary analysis from not significant to statistically significant. The EMA declared the entire dataset unreliable. The New England Journal of Medicine retracted the paper. The FDA has separately proposed withdrawing U.S. approval over the same data problems, though the drug remains available stateside while the process plays out.
Why it matters: Pulling a marketed drug for clinical trial fraud (rather than safety signals) is nearly unprecedented against a major pharma company. The episode exposes how the entire approval system depends on trust that sponsors handle their data honestly, and what happens when that trust breaks down.
Read more →Deals and Strategy
BMS Just Wrote a $15 Billion Check to China's Hottest Drug Pipeline
Bristol Myers Squibb signed a deal worth up to $15.2 billion with China's Hengrui Pharmaceuticals, covering 13 early-stage programs across oncology, immunology, and hematology. Only $950 million is guaranteed near-term cash; the rest is milestone-dependent. The deal lands despite escalating U.S.-China tensions, underscoring that patent cliff desperation trumps geopolitics when the science is compelling enough.
Read more →Cytokinetics Sues BMS Over a Heart Drug It Says BMS Had Nothing to Do With
Cytokinetics filed a preemptive patent suit against Bristol Myers Squibb, alleging BMS patented methods covering Cytokinetics' own heart drug MYQORZO despite having "zero involvement" in its development. With the cardiac myosin inhibitor market approaching $1.5 billion, the outcome could determine who controls one of cardiology's most promising drug classes.
Read more →Regulatory and FDA Watch
The FDA Commissioner Allegedly Tried to Kill a Drug Himself. It Got Approved Anyway.
Reports claim FDA Commissioner Marty Makary personally pushed to reject KalVista's rare disease drug sebetralstat, an almost unheard-of intervention in a single drug decision. HHS called the claim "totally false." The drug was approved two weeks late on July 3, 2025, giving HAE patients their first oral treatment for acute attacks, but the episode raises uncomfortable questions about political influence at the agency.
Read more →ITM's Cancer Drug Aced Its Trials, Then Got Rejected for Factory Problems
The FDA rejected ITM's radiopharmaceutical cancer drug despite strong Phase 3 data showing it helped patients live longer without tumor progression. The problem? Manufacturing quality, not the medicine itself. It's a cautionary tale for the booming radioligand therapy sector, where manufacturing challenges have been a leading cause of FDA rejection letters.
Read more →Clinical Trials and Pipeline
Capricor's Duchenne Drug Got Crushed at an FDA Panel, Then Pulled a Houdini
After a brutal 9-3 advisory committee vote against its Duchenne therapy deramiocel, Capricor's stock cratered to $4. Then the FDA agreed to review an amended filing with new 24-month data, and shares surged to $6.65. Cantor Fitzgerald upgraded the stock and raised its target from $3.50 to $28. History suggests negative adcom votes aren't always death sentences.
Read more →BioMarin Spent $270 Million on a Drug That Fixed the Biomarker but Not the Disease
BioMarin killed BMN 401 across all indications after its Phase 3 trial showed the drug could normalize a key blood biomarker but couldn't improve patients' actual bone disease on X-ray. The drug was the crown jewel of last year's $270 million Inozyme acquisition. Analysts had largely priced in the failure, limiting further downside.
Read more →Industry Signals
Biotech's Favorite Bellwether Just Raised Its Forecast
Charles River Laboratories raised its full-year profit outlook after posting its best organic growth quarter since Q3 2023. Its discovery and safety unit booked $1.19 in new orders for every dollar of revenue recognized, signaling that biotech companies are reopening their checkbooks for preclinical work. It's normalization, not euphoria, but after two brutal years, even flat ground feels good.
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