Can We Trust the Data? The Case for Validation
Real world research has produced recent newsworthy findings on topics as diverse as COVID, mental health, cancer, and dementia. [...]
Exploring the Potential and Challenges of mRNA Technology in Revolutionizing Flu Vaccines
The article discusses the potential of mRNA technology, popularized during the COVID-19 pandemic, in revolutionizing flu [...]
Respiratory Viruses Return to Seasonal Patterns After Covid-19 Disruption
During the height of the COVID-19 pandemic, other respiratory viruses such as the flu, RSV, and [...]
Reagan-Udall Foundation Calls for Overhaul of Post-Market Evidence Generation System, Suggests FDA-Led Approach
The Reagan-Udall Foundation asserts in a new report that the current post-market evidence generation system is [...]
FDA Issues Draft Guidance Recognizing the Role of Real-World Evidence in Learning More about Populations Underrepresented in Clinical Trials for Drugs and Biological Products
By: Ulka Campbell, Head of Scientific Strategy, Aetion Of the many potential use cases for real-world data (RWD) [...]
The Future of Diversity in Clinical Trials: Real-World Evidence
This episode of tHEORetically Speaking features real-world evidence experts Alexandrina Balanean, Parisa Asgarisabet, and Danielle Gentile from Cardinal Health discussing the problems caused by lack of diverse representation in clinical trials.
Global Real-World Data Market Forecast to Grow at 14.4% CAGR from 2023 to 2030, Fueled by Increased Demand for Evidence-based Medicine and Technological Advancements
The global real-world data (RWD) market, which encompasses data collected outside of clinical trials, is forecasted to grow at a [...]
Galecto Laying Off 70% of Staff and Exploring Strategic Alternatives after Failed Lung Disease Drug Trial
Boston-based biotech firm Galecto plans to lay off 29 employees, approximately 70% of its workforce, after [...]
Class-Action Lawsuit Targets Johnson & Johnson and IBM after Data Breach
Johnson & Johnson and IBM face a proposed class-action lawsuit following a data breach at J&J’s [...]
Higher Suicide Risk Among Health Care Workers, Especially Women: Study Reveals
A new study in the Journal of the American Medical Association suggests that health care workers, [...]
Christine Davis Appointed as New President of Ontada
Ontada, a McKesson business focusing on oncology real-world data and evidence, has appointed Christine Davis as [...]
FDA Updates Guidelines on Using Single Clinical Investigation as Confirmatory Evidence for New Drug Approval
The FDA has issued a draft guide to clarify how evidence from a sole clinical investigation [...]
Alexion Pharmaceuticals Nears $125M Settlement in Class Action Lawsuit Over Alleged Unethical Sales Practices
A 2016 class action lawsuit against pharmaceutical company Alexion, which claimed that the company's unethical sales [...]
Ongoing Medicare Privatization Will Hurt Pharma As Much As the IRA
The pharmaceutical industry is in a frenzy over the recently released list of the drugs subject to [...]
Cognitive Ability Tied to COVID-19 Vaccination Rates
The study published in the Journal of Health Economics investigated a link between an individual's cognitive [...]
AI-Enhanced Testing: Transforming the Landscape of Software Quality Assurance
Traditional test automation has limitations in replicating real-world user behavior and interactivity, which results in a need for an [...]
FDA Releases Guidance on Utilizing Real-World Evidence for Pharmaceutical Regulatory Review Process
The FDA has published final draft guidance for pharmaceutical companies, indicating how they can use real-world evidence to support their [...]
Atropos Health Expands into Life Sciences Sector
Atropos Health, acclaimed for its Green Button Clinical Informatics Consult Service, is expanding into the life sciences sector. It will [...]
Target RWE to Showcase Innovative Epidemiology Research and Launch Syndicated Science™ Insights
Target RWE, a leader in real-world evidence, will present innovative research in epidemiology and statistics at the International Society for [...]
FDA Approves Ipsen’s Ultra-Rare Bone Disease Drug Sohonos
The Food and Drug Administration (FDA) has approved Ipsen Pharmaceuticals' Sohonos, a drug designed to treat fibrodysplasia ossificans progressiva (FOP), [...]
Segmed Exceeds 100 Million Imaging Studies Milestone on Its Network
Segmed, a company that focuses on simplifying access to real-world medical imaging data (RWiD), has announced its network has surpassed [...]
Supreme Court Halts Purdue Pharma’s Bankruptcy Plan Worth Billions
The Supreme Court has ordered a temporary halt on the proposed bankruptcy plan for Purdue Pharma, [...]
Skepticism Surrounds NIH’s Long Covid Clinical Trials
The National Institutes of Health (NIH) initiated clinical trials for long Covid – persistent symptoms following [...]
Act4Biosimilars Advocacy Group Strives to Boost Global Adoption of Biosimilars by 2030
Act4Biosimilars, a global biosimilar advocacy initiative, aims to increase global adoption of biosimilars by at least [...]
FDA Accelerates Review of HuidaGene’s Treatment for Inherited Blindness
The US Food and Drug Administration (FDA) has granted HuidaGene Therapeutics a rare pediatric disease designation (RPDD) to accelerate the [...]