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Opinion: FDA commissioner: ‘Smarter,’ real-time clinical trials could transform drug development

Why does it take a new drug 10 years, on average, to come to market? Part of the reason lies in the dead time in the process.  

Historically, trials have required tedious tabulations and repeated application submissions between phases, which is why 45% of the time from a Phase 1 trial until final submission is spent without any ongoing clinical trial in progress — idle time in the system.   

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Why does it take a new drug 10 years, on average, to come to market? Part of the reason lies in the dead time in the process.  

Historically, trials have required tedious tabulations and repeated application submissions between phases, which is why 45% of the time from a Phase 1 trial until final submission is spent without any ongoing clinical trial in progress — idle time in the system.   

Read the rest…

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QurAlis’ Phase 2 data bolster case for genetic approach to sporadic ALS

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Biogen’s Qalsody won FDA approval in 2023 to treat a rare, genetic form of amyotrophic lateral sclerosis. On Tuesday, QurAlis presented interim Phase 2 data showing the potential of a similar drug to more broadly treat the neurodegenerative disease.

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Madrigal extends MASH deal streak with Arrowhead drug that J&J didn’t want

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Madrigal Pharmaceuticals has made its fourth MASH deal in 10 months, further signaling its ambitions to be not just the first drugmaker for the fatty liver disease, but also the owner of the field’s broadest …

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STAT+: Pharmalittle: We’re reading about RFK Jr. targeting antidepressants, J&J pushing an IBD drug, and more

Rise and shine, another busy day is on the way. However, this is also shaping up as a beautiful day as well, given the clear and sunny skies — and delicious breezes — enveloping the Pharmalot campus this morning. This calls for celebration with a cup of stimulation, and we are opening a new package of cinnamon buns for the occasion. Spring has sprung, after all. What is upon us right now, however, is our ever-growing to-do list. Sound familiar? So here are some items of interest. Have a great day, everyone. …

U.S. Health and Human Services Secretary Robert F. Kennedy Jr. announced several initiatives intended to rein in the prescription of selective serotonin reuptake inhibitors, the most widely prescribed class of antidepressants, which he has described as exceptionally difficult to quit, The New York Times writes. The initiative focuses on the most widely prescribed class of psychiatric medications, first-line treatments for depression and anxiety that include Zoloft, Lexapro, Paxil, and Prozac. In 2026. 16.7% of U.S. adults, or roughly one in six, reported currently taking one of these pills. The changes — new trainings, reimbursement mechanisms, and clinical guidelines — nudge clinicians to help patients get off medications, and to consider non-pharmaceutical interventions, like therapy, nutrition, and exercise.

A closely watched therapy developed by Johnson & Johnson failed to show a statistically meaningful improvement for patients with inflammatory bowel disease. But the company plans to advance the drug into late-stage testing, focusing on a growing subgroup of patients, STAT tells us. On Tuesday, trial investigators presented the results of a study that tested how well combining the drugs Tremfya and Simponi would stop the immune system from mistakenly attacking healthy tissues in the digestive tract. J&J tested the combined therapy in two Phase 2b clinical trials hitting both major forms of inflammatory bowel disease — ulcerative colitis and Crohn’s disease. In each trial, the combination performed better than the individual drugs, but did not meet the primary endpoint of clinical remission. 

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Rise and shine, another busy day is on the way. However, this is also shaping up as a beautiful day as well, given the clear and sunny skies — and delicious breezes — enveloping the Pharmalot campus this morning. This calls for celebration with a cup of stimulation, and we are opening a new package of cinnamon buns for the occasion. Spring has sprung, after all. What is upon us right now, however, is our ever-growing to-do list. Sound familiar? So here are some items of interest. Have a great day, everyone. …

U.S. Health and Human Services Secretary Robert F. Kennedy Jr. announced several initiatives intended to rein in the prescription of selective serotonin reuptake inhibitors, the most widely prescribed class of antidepressants, which he has described as exceptionally difficult to quit, The New York Times writes. The initiative focuses on the most widely prescribed class of psychiatric medications, first-line treatments for depression and anxiety that include Zoloft, Lexapro, Paxil, and Prozac. In 2026. 16.7% of U.S. adults, or roughly one in six, reported currently taking one of these pills. The changes — new trainings, reimbursement mechanisms, and clinical guidelines — nudge clinicians to help patients get off medications, and to consider non-pharmaceutical interventions, like therapy, nutrition, and exercise.

A closely watched therapy developed by Johnson & Johnson failed to show a statistically meaningful improvement for patients with inflammatory bowel disease. But the company plans to advance the drug into late-stage testing, focusing on a growing subgroup of patients, STAT tells us. On Tuesday, trial investigators presented the results of a study that tested how well combining the drugs Tremfya and Simponi would stop the immune system from mistakenly attacking healthy tissues in the digestive tract. J&J tested the combined therapy in two Phase 2b clinical trials hitting both major forms of inflammatory bowel disease — ulcerative colitis and Crohn’s disease. In each trial, the combination performed better than the individual drugs, but did not meet the primary endpoint of clinical remission. 

Continue to STAT+ to read the full story…

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