This paper explains the challenges patients face in traditional trial settings as well as how Aparito overcomes these challenges; how remote video is able to capture real-world evidence (RWE) while improving the patient experience; and how Aparito provides more meaningful patient data while protecting patient privacy.
Using Assessment Tools to Determine the Validity of Non-Randomized Studies
Analysis, Body Mass Index (BMI), Clinical Trials, Diabetes, FDA/Regulatory, IQVIA, National Institute for Health and Care Excellence (NICE), Nonrandomized studies (NRS), Patients, R&D, Randomized Controlled Trials (RCTs), Real world evidence, ResearchersAs real world evidence (RWE) becomes a more prevalent resource for confirming and expanding product benefit-risk profiles, non-randomized studies (NRS) are emerging as a valuable generator of real world data (RWD). Joan Largent – Senior Director, Epidemiology and Outcomes Research at IQVIA – discusses the findings of her recent study and how researchers can utilize assessment tools for their ability to accurately assess NRS validity.
Biohaven Presentation at AAN Showed Decreased Opioid Use in Migraine Patients Following Nurtec® ODT Therapy: A Real-World Administrative Claims Analysis
Acute Migraine, Episodic Migraine, Hydrocodone, Migraine, Migraine Headaches, Opioid Dependence, Opioid Prescriptions, Opioid Safety, Prescriptions, R&D, Real world evidence, Research & Development, TherapeuticsLongitudinal medical and prescription claims were used to assess opioid prescriptions and MME’s dispensed amongst migraine patients nine months prior to and nine months following Nurtec® ODT initiation. Among […]
A $1 billion fund backed by over 20 drugmakers made its first set of investments on April 4 in two biotechnology startups, nearly two years after it was launched to help struggling antibiotic makers tackle the threat of antibiotic-resistant bacteria.
U.S. FDA Advisers to Discuss Additional COVID Vaccine Boosters
BNT162b2 (Pfizer and BioNTech), Coronavirus Disease 2019 (COVID-19), Coronavirus Disease 2019 (COVID-19) Reinfections, COVID-19 booster shots, COVID-19 shots, COVID-19 Vaccines, FDA, FDA Statements, FDA/Regulatory, mRNA-1273/Moderna COVID-19 Vaccine (Moderna), Omicron (B.1.1.529) (South Africa), Research & Development, Therapeutics, VaccinesThe U.S. Food and Drug Administration’s expert advisers will discuss the timing of additional COVID-19 vaccine boosters and the people eligible for the extra shots in a meeting later this week, the health agency said on April 4.
Roche Says U.S. FDA Grants Priority Review to Actemra for COVID-19
Business, Coronavirus Disease 2019 (COVID-19), Coronavirus Disease 2019 (COVID-19), COVID-19 antibody drugs, COVID-19 antibody therapy, COVID-19 Therapeutic, COVID-19 therapeutic candidates, COVID-19 Therapeutics, COVID-19 Therapies, FDA, Priority Review, R&D, Research & Development, TherapeuticsThe U.S. Food and Drug administration granted priority review to Roche’s Actemra/RoActemra for the treatment of COVID-19 in hospitalized adults.
FDA Accepts Dupixent® (dupilumab) for Priority Review in Patients Aged 12 Years and Older with Eosinophilic Esophagitis
Blockbusters, Eosinophilic Cells, Eosinophilic Esophagitis, Inflammatory Diseases, Regeneron Pharmaceuticals, Research & Development, Sanofi, Spplemental Biologics License Application (sBLA), TherapeuticsThe U.S. Food and Drug Administration accepted for Priority Review the supplemental Biologics License Application for Dupixent (dupilumab) 300 mg weekly to treat adult and pediatric patients aged 12 years and older with eosinophilic esophagitis (EoE), a chronic and progressive type 2 inflammatory disease that damages the esophagus and impairs the ability to swallow.
Bristol Myers Squibb announced results from an extended study to evaluate the long-term effects of taking the cardiovascular drug mavacamten.
A panel of experts and leaders across healthcare, biopharma, and high tech will explore how to break down silos and think like a learning health ecosystem.
Verantos – a market leader in high-validity real-world evidence generation – announced that along with its research partners, the company accomplished a significant step forward in applying advanced real-world evidence approaches to non-alcoholic steatohepatitis (NASH).