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Understanding the evidence used in drug product withdrawals

European Pharmaceutical Review

Between 1999 and 2001, it supported 17 percent of withdrawals, between 2002 and 2011, it supported 26 percent of withdrawals and by 2012 to 2016, 80 percent of withdrawals were supported by observational studies (cohort, case-control, or other epidemiologic design). Meta-analyses contributed least frequently (31.4 As of October 2023, 62.93

Safety 108
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Treating Alzheimer’s: regulatory hurdles in an anti-amyloid revolution

European Pharmaceutical Review

This study has been hailed as a breakthrough as the data show that Leqembi achieved a 27 percent reduction in the progression of Alzheimer’s, provided patients were treated early following the diagnosis of the disease. These treatments are thought to work best when administered to patients as early as possible post-diagnosis.

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The State of the Union in Cancer Innovation

PM360

However, due to conjugation instability and unfavorable safety profiles of currently available ADCs, we can still do more to ensure ADCs are more broadly available and amenable options for the patients who need them. Cellectis is pioneering the concept of off-the-shelf and ready-to-use gene-edited CAR T-cells to treat cancer patients.

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Valneva’s Lyme disease vaccine faces final clinical test in a sparse landscape

Pharmaceutical Technology

A vaccine called Lymerix , then manufactured by SmithKline Beecham, was approved in the US in 1998 but was quickly withdrawn in 2002 due to insufficient custo mer demand. In a separate Phase II VLA15-221 study, which looked at adult and pediatric patients, the vaccine had stronger immunogenicity in children than in adults.

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Paving the way for anti-Abeta active immunotherapy

European Pharmaceutical Review

Targeting toxic species of Abeta, such as multimers (with aducanumab and lecanemab) or pyroglutamate Abeta3-42 (with donanemab), induced significant removal of Abeta plaque load in the brains of Alzheimer’s patients, leading to the delay in cognitive decline. Treatment with the mAbs delayed cognitive decline by 2.6 months for lecanemab and 5.5