Watchdog Wednesday: Reading the FDA’s Mixed Signals on Rare Diseases
Sponsors keep misreading red flags for green, yet the traits FDA actually falls for are predictable enough to plan a whole program around.
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Sponsors keep misreading red flags for green, yet the traits FDA actually falls for are predictable enough to plan a whole program around.
Two of the world's biggest cancer franchises are learning the same lesson: a good result is where the argument starts, not where it ends.
GSK spends $10.6bn to outrun a patent cliff while the Pentagon quietly reprices the supply chain underneath everyone. Two different bets on the same question: what is access actually worth.
Cutting headcount to survive the next milestone creates exposures distinct from those of growth, and most boards underestimate them.
Two of pharma's most crowded fields, and no agreement on whether the answer is to crowd in further or step away.
The UK's new "notifiable trial" route can shave weeks off your timeline, but only if you sequence your jurisdictions like a chess player rather than a tourist.
The needle-shy are the prize now, and four companies showed up to ADA with a pill and a percentage.
ASCO ended a week ago. The filing and the deal structure that deserve a closer look.
Bundibugyo had no vaccine, no treatment, no diagnostic for seventeen years. It took 900 cases to change the math.
Two qualify as first-in-class among 2032's ten biggest oncology bets. So why is big pharma paying nine figures for assets that haven't read out?
The AI trial pilot survived its own architects' departure. For one more month, the docket is where it gets decided.
Daraxonrasib doubles survival in pancreatic cancer, BMS puts numbers behind its CELMoD bet, and the trial count quietly falls again.