Drugs

Positive Trial Results for Amgen’s Tezepelumab

Amgen and AstraZeneca say their investigational asthma drug tezepelumab achieved positive topline results in the Phase 3 NAVIGATOR trial. A statement from the companies says tezepelumab demonstrated a statistically significant reduction in exacerbations compared to placebo in patients with severe asthma.

The statement says the drug was very well tolerated in patients with severe asthma and preliminary analyses showed no meaningful differences in safety results between the tezepelumab and placebo groups.

The statement describes tezepelumab as “a potential first-in-class medicine that blocks the action of the thymic stromal lymphopoletin (TSLP), an epithelial cytokine that plays a key role across the spectrum of asthma inflammation. NAVIGATOR is the first Phase 3 trial to show benefit in severe asthma by targeting TSLP.”

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