STAT+: Pharmalittle: We’re reading about FDA views on a Duchenne drug, GSK cost savings, and more

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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 new 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. Our choice today is witch’s brew. Meanwhile, here are a few items of interest. Hope you have a smashing day and, of course, do stay in touch. …

The U.S. Food and Drug Administration said that a Capricor Therapeutics stem cell treatment for Duchenne muscular dystrophy did not meet the objectives of a Phase 3 trial — contrary to company claims last year, STAT says. Last December, Capricor said its drug, known as deramiocel, met both the primary and secondary endpoints in a large, randomized study. It was a striking result in a fatal, childhood disease that has proven stubbornly difficult to treat, despite immense advances in genetic medicine. But in documents released Monday in advance of a hearing this week where FDA advisers will weigh in on the drug, the agency said the study fell short.

The world risks a resurgence of the HIV epidemic after international financing to combat the infectious disease suffered a “profound shock” last year, STAT writes, citing a new report from UNAIDS, the United Nations agency. Overall, government funding declined by more than $1.5 billion to $7.3 billion in 2025, an 18% drop and the lowest level in nearly two decades. Prevention programs, in particular, have historically relied heavily on donor assistance in most regions, especially in sub-Saharan Africa, where it reached 83% two years ago. Although the U.S. was blamed for funding cuts, it still provides 74% of government donor funding.

Continue to STAT+ to read the full story…

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