Data Dose November 2024 #1
MedSafetyWeek Unites the World for Safer Medicines
In our interconnected world, ensuring medication safety is a shared responsibility. MedSafetyWeek unites healthcare professionals, patients, and regulators worldwide to emphasize the importance of reporting adverse drug reactions (ADRs). For pharmacovigilance specialists, timely ADR reporting can mean the difference between life and death. But how does a single week create such a powerful global impact? Read more...
6-Year Pharmacovigilance Data Suggests Brodalumab Safe for Psoriasis Despite Boxed Warning
New six-year pharmacovigilance data on brodalumab for moderate-to-severe psoriasis reveal consistency with previously established safety findings, with no new cases of completed or attempted suicide and a low rate of fungal infections. These findings were presented at the 44th Annual Fall Clinical Dermatology Conference in Las Vegas, led by researchers including Mark Lebwohl, MD, dean of clinical therapeutics at the Icahn School of Medicine at Mount Sinai. Read more...
A diabetes drug, twice rejected, stumbles again — but its developer persists
In 2019, the FDA initially rejected sotagliflozin for type 1 diabetes patients, during Lexicon's partnership with Sanofi. Sanofi later exited the partnership, paying Lexicon $260 million. Although Lexicon's appeal was denied the following year, the company continued developing sotagliflozin, which eventually gained approval in the EU as an adjunct treatment to insulin in type 1 diabetes and was launched under the brand name Zynquista. Read more...
Neurotechnology’s rapid evolution – What consequences for the EU regulatory landscape?
Neurotechnology, the intersection of neuroscience and technology, encompasses tools and methods aimed at enhancing our understanding of brain function and improving or restoring its capacities. These advancements are creating new opportunities across sectors, from healthcare to everyday life. However, the swift progress in neurotechnology brings essential questions about its societal impact and regulatory needs. As these technologies overlap with various EU legislative and policy efforts, a cohesive and integrated approach will be crucial for the EU to establish a regulatory framework for neurotechnologies. Read more...