The FDA seeks to update its Sentinel Initiative postmarket safety monitoring system in a five-year plan. The system, which will feature natural language processing and machine learning, will incorporate more than 10 years' worth of data gathered by Sentinel.
The FDA has announced several changes to the Risk Evaluation and Mitigation Strategy for clozapine, noting pharmacies and prescribers must be certified in the Clozapine REMS Program by Feb. 28 if they want to continue dispensing or prescribing the drug.
Almirall's Seysara, or sarecycline, is available for the treatment of patients ages 9 and older who have inflammatory lesions of non-nodular moderate to severe acne vulgaris.
Johnson & Johnson and Apple have teamed up to conduct a multiyear study starting this year to assess the efficacy of the Apple Watch, along with J&J's heart health monitoring app, in detecting irregular heart rhythms. "The goal is to identify early on [atrial fibrillation] and prevent stroke by combining the physical know-how from Apple and what we have from the medical and scientific know-how," said Paul Stoffels, Johnson & Johnson's executive vice president and chief scientific officer.
Researchers used a common wearable movement sensor to measure physiological responses of 63 children ages 3 to 7 to a 90-second mood induction task with the goal of detecting internalizing disorders, including depression and anxiety. The study, published in PLOS ONE, found that performing a machine learning algorithm-based analysis of just 20 seconds of movement data had an 81% accuracy rate in identifying children with internalizing disorders.
Sens. Ron Wyden, D-Ore., and Jeff Merkley, D-Ore., are urging the FDA to update regulations to allow the use of hemp products, such as cannabidiol, in beverages, dietary supplements and food products. With passage of the Hemp Farming Act, "it was Congress' intent to ensure that both US producers and consumers have access to a full range of hemp-derived products, including hemp-derived cannabinoids," they wrote to FDA Commissioner Scott Gottlieb.
The European Commission has approved Janssen's prostate cancer drug Erleada, or apalutamide, as a treatment for nonmetastatic castration-resistant prostate cancer among men at high risk for metastatic diseases. The decision was based on Phase III SPARTAN trial results that showed the drug, in combination with androgen deprivation therapy, significantly reduced distant metastasis or mortality risk by 72% and improved median metastasis-free survival by over three years, compared with an improvement of just more than one year in the placebo group.
Aurobindo Pharma, through its wholly owned subsidiary Acrotech Biopharma, will purchase Spectrum Pharmaceuticals' seven injectable oncology products. Spectrum will get $160 million in cash upfront and up to $140 million upon reaching regulatory and sales-based targets.
CorMedix reported positive data from its late-stage study assessing its Neutrolin catheter lock solution developed for patients undergoing hemodialysis. Because the product's efficacy was established after an interim analysis, which showed participants receiving Neutrolin experienced a 72% reduced risk of catheter-related bloodstream infections versus those receiving heparin, the trial was stopped early.
A follow-on funding raised $100 million for Mirati Therapeutics, which plans to launch a late-stage trial in the first half of 2019 for its lead candidate sitravatinib, a multiple receptor tyrosine kinase inhibitor, combined with a checkpoint inhibitor to treat non-small cell lung cancer. Revance Therapeutics, a neuromodulator developer that is conducting a late-stage study to evaluate its DaxibotulinumtoxinA for Injection for glabellar lines, also pulled in $100 million in a separate follow-on funding.
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