Drugs

FDA Rejects Verily Parkinson’s Letter of Intent

FDA says it has decided not to accept a Verily Life Sciences 1/25 Letter of Intent for the Virtual Motor Exam for Parkinson’s disease, Part 3 Estimator, as measured by the Verily Study Watch. An agency determination letter says the letter proposed assessment of motor symptom severity in adults who have been diagnosed with Parkinson’s disease across the full range of disease progression.

The letter says the Verily watch measures a change in digitally assessed parameters of a subset of Parkinson’s disease motor signs from the Movement Disorder Society—Unified Parkinson’s Disease Rating Scale Part 3. But, it says, that part is limited in its capacity to evaluate meaningful aspects of concepts of interest that are relevant to patients’ ability to function in day-to-day life.

The agency says that when evaluating drug efficacy in Parkinson’s disease, it prefers “content that is more representative of daily life functioning,” such as that contained in Part 2 of the rating scale.

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