Drugs

J&J Scraps Alzheimer’s Trial After Disappointing Data

Johnson & Johnson has decided to discontinue its Auτonomy Phase 2b Alzheimer’s study after interim data showed its experimental antibody posdinemab failed to produce a statistically significant benefit in slowing the clinical decline of early-stage Alzheimer’s disease. The company described the trial — which it billed as a “first-of-its-kind precision approach” — as an important learning exercise. Analysts say the outcome highlights how difficult it remains to develop effective therapies that target tau, a key protein implicated in Alzheimer’s pathology.

The Auτonomy trial reportedly used a blood-based biomarker (phosphorylated tau) to select patients, aiming to enroll individuals with a level of tau pathology that was high enough to show disease progression but not so advanced that it could not be modified. The drug was designed to target phosphorylated tau (p-tau), particularly a mid-domain region believed to drive the spread of toxic tau aggregates between neurons.

According to J&J, a scheduled interim analysis found that posdinemab did not meaningfully outperform placebo in slowing decline on clinical measures. Given the data review, the company decided to terminate the trial early — a signal that the treatment was unlikely to meet its primary endpoint.

J&J says it will share detailed findings with the scientific community “in due course.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome