Trending News Today: FDA Questions Efficacy Data of COPD Drug

A smart pill equipped with an ingestible sensor may help improve patient adherence to Truvada, a daily pre-exposure prophylaxis (PrEP) pill for HIV, STAT reported. According to the article, the digital pills used in a PrEP study relay information across 3 devices: an FDA-approved ingestible sensor that is attached to the pill, a Band Aid-like patch worn on the upper torso, and a smartphone. The smart pill’s sensor records exactly when patients are taking the medication and sends the information via Bluetooth to the patient’s phone, allowing them to follow how well they have followed their medication schedule, the article reported.

Officials with the FDA have raised doubts about data submitted by GlaxoSmithKline for its drug Nucala, Reuters reported. According to the article, the FDA staff highlighted the drug’s failure to meet a statistical threshold for efficacy in 1 of the clinical trials, and uncertainty in defining the group of patients who could benefit from the treatment. Nucala, which is already approved for treating patients with severe asthma, is being reviewed by the FDA for reducing the worsening of symptoms of chronic obstructive pulmonary disease.

New research has found that a woman’s levels of female sex hormones, including estrogen and progesterone, may influence her risk of Alzheimer disease and other forms of dementia, NPR reported. According to the article, 1 study that looked at nearly 15,000 women in California found an association between a woman’s reproductive history and her risk of memory problems later in life. Another study indicates that the more months of pregnancy experienced correlates to a lower risk of developing Alzheimer disease. The findings all suggest that female sex hormones can affect a woman’s risk of developing Alzheimer and that greater exposure to these hormones can reduce the risk, the article reported.