Blog

Law enforcement agencies take aim at fake weight-loss drugs: The Pharmaceutical Security Institute is working with international law enforcement agencies and with companies that identify counterfeit products to stanch the flow of fake weight-loss and diabetes drugs. The European Medicines Agency and the UK’s Medicines and Healthcare products Regulatory Agency recently warned that pre-filled pens falsely labelled as Ozempic were found at wholesalers in the EU and the UK.

Treating drug-resistant combat wound infections: A $1.2 million grant from the US Army will support a study that aims to find an optimal regimen to treat drug-resistant combat wound infections and reduce the potential for serious side effects. Researchers are adapting micro-mist fusion technology, which was originally created to apply skin care products, to deliver antibiotics to the wound without causing damage.

Fox “wants to get things done” with Parkinson’s research: Experts suggest that twice as many Americans may have Parkinson’s disease as officially diagnosed, and research supported by the Michael J. Fox Foundation is making notable progress, including the recent discovery of a significant biomarker for early detection. Fox said that although he might not fully understand the scientific intricacies of the research, his focus is on supporting the researchers, not seeking personal recognition: “We don’t want to be famous. We don’t want to be rich. We don’t want to be celebrated. We want to get things done.”

Pregnant women with diabetes may benefit from insulin delivery system: A study in The New England Journal of Medicine found that Ypsomed’s mylife Loop system was associated with more time spent within the target pregnancy glucose level range among pregnant people with type 1 diabetes. Researchers reported that participants using the insulin delivery system gained 3.5 kg less weight.

Demand for weight-loss drugs outpaces current supply: Rising demand is outstripping the current supply of medications such as Wegovy, Ozempic and Mounjaro for patients seeking weight loss, some physicians say. The drugs are not specifically FDA-approved for weight loss; however, many physicians prescribe them off-label for that purpose, and some pharmaceutical makers have said they are working to boost production capacity.

Pop music used to release insulin in mice: By incorporating a sound-sensitive ion channel from E. coli into insulin-producing human cells that were implanted in mice, researchers could trigger insulin release by playing low-bass pop music, exemplified by Queen’s “We Will Rock You,” according to research in The Lancet. While this research is promising for remote control of medical processes, questions about the longevity of the cells, safety mechanisms and fine-tuning for humans still need to be addressed, said Sreekanth Chalasani, a Neuroscientist at the Salk Institute who was not involved in the research.

FDA unveils plan to regulate lab-developed tests: The FDA at the end of September 2023 unveiled a proposal to begin regulating laboratory-developed tests as medical devices, with enforcement discretion to be phased out over five years to give LDT manufacturers time to adjust. FDA Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren said the plan is to require LDT makers to register their tests with the Agency, and the tests will be reviewed based on their risk to patients.

FDA issues guidance on pre-approval plant inspections: The FDA will continue to use “alternative tools” such as remote interactive evaluations to assess compliance with good manufacturing practices in support of new drug, abbreviated new drug and biologics license approval applications, according to draft guidance formalizing the Agency’s inspection strategy. Factors the agency will consider when deciding whether remote or onsite inspection is appropriate include inspection history, product type, and feasibility of in-person inspection.

HungeroTrial’s Antal Solyom highlights the overwhelming amount of re-certification applications, noting that some notified bodies are not even accepting new device applications.

Citing International Trade Commission (ITC) Ban, Apple to halt sale of Apple Watch Series 9, Ultra 2 this week: Say sayonara to this popular wearable as its potential ban may go into office effect starting December 25