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Sertraline manufacturer recalls antidepressant batch after UK packaging mix-up

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A subsidiary of Indian drugmaker Hetero Group mistakenly packaged two types of antidepressants in packs of sertraline, potentially posing risks to patients.

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Cytospire hauls in $83M for a new type of T cell engager

The British biotechnology startup is making “pan-gamma delta” T cell engagers it says can address the limitations of similar, existing therapies. 

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The British biotechnology startup is making “pan-gamma delta” T cell engagers it says can address the limitations of similar, existing therapies. 

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STAT+: Johnson & Johnson advances IBD therapy, despite trial miss

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. 

On Tuesday, trial investigators presented the results of Johnson & Johnson’s DUET study, testing how well combining the drugs Tremfya and Simponi would stop the immune system from mistakenly attacking healthy tissues in the digestive tract. It’s a follow-up to a 2022 clinical trial that showed a significant benefit to patients, nearly doubling the rates of disease remission and spurring several companies to start developing combination approaches for IBD. 

Johnson & Johnson tested its combined therapy, dubbed JNJ-4804, 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 therapy 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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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. 

On Tuesday, trial investigators presented the results of Johnson & Johnson’s DUET study, testing how well combining the drugs Tremfya and Simponi would stop the immune system from mistakenly attacking healthy tissues in the digestive tract. It’s a follow-up to a 2022 clinical trial that showed a significant benefit to patients, nearly doubling the rates of disease remission and spurring several companies to start developing combination approaches for IBD. 

Johnson & Johnson tested its combined therapy, dubbed JNJ-4804, 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 therapy 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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Vertex drops mRNA cystic fibrosis program over ‘tolerability’ issues

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Vertex Pharmaceuticals said it has dropped development of an mRNA-based cystic fibrosis therapy, after facing challenges delivering the genetic medicine similar to those that have troubled other parts of the field.

The Boston-based company

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