STAT+: Pharmalittle: We’re reading about FDA reforming clinical trials, a Pfizer setback, and much more news

Top of the morning to you. Gray skies are hovering over the Pharmalot campus right now, but our spirits remain sunny, nonetheless. Why? We will trot out a bit of insight from the Morning Mayor, who would say “Every day should be unwrapped like a precious gift.” To celebrate the notion, we are brewing still more cups of stimulation and invite you to join us. Remember, a prescription is not required. Our choice today is orange creme. Meanwhile, here are a few items of interest. Hope you have a smashing day and, of course, do stay in touch. … Pfizer disclosed that an experimental lung cancer drug it hoped could replace a widely used chemotherapy fell short in a clinical trial, STAT writes. Expectations had been high that the drug, sigvotatug vedotin, could replace docetaxel, a chemotherapy initially approved in 1996. Last year, Pfizer chief executive officer Albert Bourla said on an earnings call the drug “could be a driver of growth later this decade.” The company obtained the drug when it acquired Seagen for $43 billion in 2023. But the drug did not result in a statistically significant improvement in overall survival over docetaxel. The U.S. Food and Drug Administration announced a pilot program to speed early-stage clinical trials, which it maintained will reduce development timelines by six to 12 months, in hopes of encouraging U.S.-based trials and combating Chinese dominance in the field, STAT tells us. The pilot comes as the agency, through the president’s 2027 fiscal budget, asks Congress to establish a permanent, faster process for the existing Investigational New Drug pathway. Acting FDA Commissioner Kyle Diamantas told reporters that the FDA will issue guidance reaffirming that a single, high-quality Phase 3 trial supported by confirmatory evidence is enough to allow drug approval. Continue to STAT+ to read the full story…