Reps. Greg Walden, R-Ore.; Brett Guthrie, R-Ky.; and Morgan Griffith, R-Va., sent letters to Mallinckrodt Pharmaceuticals, Insys Therapeutics and Purdue Pharma stating that they have relaunched a probe into the companies' alleged role in the opioid crisis. The case explores "potential breakdowns in the controlled-substances supply chain, which may have contributed to the nation's opioid epidemic, and the role of certain opioid manufacturers in such potential breakdowns," they wrote.
Ad buyers and brands are rattled by the fact that Chrome is eliminating cookies and they're "losing their foundational tracking mechanism," Alison Weissbrot writes. She contends Google's Privacy Sandbox solution is "still too theoretical" and suggests marketers start the changeover process by considering first-party data usage, rethinking targeting and optimization and considering new measurement techniques.
Facebook has disbanded a team it had working on possible WhatsApp ad integrations, which also caused the messaging service's founders to resign nearly two years ago, according to The Wall Street Journal. Facebook has plans to develop Status ads and is working on revenue-generators, such as tools for businesses to connect with consumers.
Researchers developed a noninvasive and wearable sensor that detects low blood glucose levels using artificial intelligence and electrocardiogram signals by tracking a person's heart rate. Featured in the journal Nature, the new device was tested in two small pilot studies and was found to have around 82% efficacy in detecting hypoglycemia, and could be an alternative to finger-prick tests.
A joint FDA advisory committee advised against approval of Intellipharmaceutics' Aximris, an extended-release opioid, the third pain drug rejected by the panel this week. Nektar Therapeutics' oxycodegol, and a drug combination of tramadol and celecoxib, also failed to gain the panel's support.
The FDA has recognized the latest version of ISO 14971:2019, the International Organization for Standardization risk management standard for medical devices, as well as more than 100 other consensus standards. The standards cover radiology, software, anesthesiology, biocompatibility, physical medicine, sterility, materials and other topics.
The Environmental Protection Agency has removed a section inquiring about the possible use of low volumes of ethylene oxide to sterilize medical equipment from the final version of its advanced notice of proposed rulemaking. The removal comes after the FDA asserted jurisdiction over use of the sterilizer at medical device sterilization plants.
Novo Nordisk announced that the FDA has approved its application for the expanded indication of its drug Ozempic, or semaglutide, to diminish the risk for major adverse cardiovascular events in adult patients with type 2 diabetes who have been previously diagnosed with heart disease. The approval was based on data from its SUSTAIN 6 trial.
The FDA sent a warning letter to Chinese OTC drug firm Huaian Zongheng Bio-Tech after finding out the company's Huaian, China, plant sent OTC drugs to the US without testing the ingredients or retaining samples of the final products to see if they comply with specifications.
Boston Scientific can continue its patent suit against Micro-Tech USA and Micro-Tech Nanjing alleging that three of Boston Scientific's patents for its Resolution and Resolution 360 endoscopic hemostatic clips were infringed by Micro-Tech SureClip products, a Delaware federal judge has ruled.
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