Curelator and University of Calgary Study Finds a Lack of Association Between Migraines and Stress Levels
Curelator, a digital health company based in Cambridge, MA, released its findings for the largest international study that focused on the relationship between stress and migraines in the January issue of Headache, The Journal of Head and Face Pain in collaboration...
Australia’s TGA Takes First Steps in Approving Novavax COVID-19 Vaccine
Yesterday (1/20), Novavax received provisional determination from Australia’s Therapeutic Goods Administration for its COVID-19 vaccine, marking the first steps in gaining provisional approval. Australia’s provisional approval pathway allows for drug therapies (or...
Seneca Biopharma Announces Results for Treatment of Ischemic Stroke in Phase 2 Clinical Trial
Seneca Biopharma announced today (1/20) its preliminary top-line results for their Phase 2 ischemic stroke study. The trial, which took place in Beijing, China, focused on evaluating the relative safety of NSI-566, a neural stem cell therapy, in patients afflicted...
FDA Releases AI/ML Five-Part Action Plan for SaMD
The U.S. Food and Drug Administration (FDA) released its artificial intelligence/machine learning five-part action plan for software as a medical device (SaMD). The FDA announced in the plan its intention to create a tailored regulatory framework for SaMD, as well as...
EMA Issues Draft Guidance Parallel to Article 58 and Centralized Authorization Reviews
The European Medicines Agency (EMA) issued a draft guidance yesterday (1/14) for medicines intended to be used in low- to middle-income countries outside the European Union (EU). The Article 58 process calls for EMA’s Committee for Medicinal Products for Human Use...
Medtronic Announces First Enrollment of Adaptive Deep Brain Stimulation (aDBS) Trial for Parkinson’s Patients
Medtronic announced today (1/14) the launch of its clinical trial enrollment of the innovative Adaptive DBS Algorithm for Personalized Therapy in Parkinson’s Disease (ADAPT-PD). The novel trial, which will take place across 12 research study sites in the US, Europe...
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