Drugs

J&J Collaborations on Alzheimers, Throat Cancers, etc.

Johnson & Johnson Innovation LLC has entered into more than a dozen new product collaborations to address areas of high unmet medical need. Priority areas that Johnson & Johnson (J&J) says it is devoting resources to include the use of artificial intelligence to detect early signs of Alzheimer’s disease; identifying throat cancers with a simple saliva test; and harnessing the microbiome to treat sleep disorders.

For example, J&J and Janssen Pharmaceuticals are going to work with the University of Pennsylvania’s Gene Therapy Program assess adeno-associated virus vectors developed by the academic institution and antibodies targeting Alzheimer’s disease developed by Janssen. A separate collaboration with the Northern California Institute for Research and Education and the San Francisco Veterans Affairs Medical Center will investigate the utility of online neuropsychological assessments to monitor brain health in elderly people. And another collaboration with Queensland University of Technology in Australia will seek to develop a saliva-based diagnostic for early detection of throat cancers. The new technology aims to identify people who are at risk for throat cancers and intercept asymptomatic disease before invasive treatments are needed.

To view the entire listing of new collaborations, click here.

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