Drugs

AstraZeneca Stops Phase 2 Trial of Asthma Drug

AstraZeneca says it has stopped a Phase 2a trial for asthma therapy AZD9412 (inhaled interferon beta) based on an interim analysis that found an “overall very low number of reported severe exacerbations” that could make primary endpoint conclusions difficult. “The interim analysis confirmed the positive safety and tolerability profile seen in previous trials, and inhaled IFN-b remains an interesting treatment opportunity for patients with respiratory disease,” it says. AstraZeneca next will review the data and study design before deciding on the best way forward for the development program. The therapy was developed by Synairgen and licensed to AstraZeneca 6/2014.

AstraZeneca says it will evaluate the key data collected from the INEXAS trial with a focus on secondary endpoints that are most predictive of disease worsening to exacerbation. Full results are expected in early 2017.

In the INEXAS trial, asthma patients were dosed with placebo or AZD9412 at the onset of common cold symptoms. Previous research has shown that common colds can cause severe exacerbations of asthma and that boosting the antiviral defenses of the lung with AZD9412 could prevent exacerbations from developing, according to Synairgen.

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