Navigating the FDA Real-Time Oncology Review Process for Sponsors
Started in 2018, the FDA’s “Real-Time Oncology Review (ROTR)” project gives sponsors a head start on the application review [...]
“Specialty Pharmacy’s Post-Pandemic Outlook” Asembia 2021 Keynote Recap
The future of specialty pharmacy in the post-pandemic world was the topic of the October 27th keynote sessions at Asembia [...]
Now Available: Economic & Related Consulting Service Revenues WORLD REPORT + DATABASE
Research and Markets has released their Economic & Related Consulting Service Revenues World Report + Database, which covers products and [...]
“The Power of Patient Advocacy” – Value & Outcomes Spotlight Seeks Submissions
ISPOR’s journal Value & Outcomes Spotlight welcomes submissions for its January/February 2022 issue, which is themed, “The Power of Patient [...]
ISPOR Signal Series: The New Science of Cause and Effect
The next ISPOR Signal series event will feature Judea Pearl, professor of computer science and director of the Cognitive Systems [...]
Role of Pharmacy Benefit Managers Under Congressional Scrutiny
The role of pharmacy benefit managers (PBM) on patient out of pocket prices was examined by a US congressional hearing [...]
Gene Therapy for Beta Thalassemia Gene Under ICER Assessment
A gene therapy for beta thalassemia will undergo ICER assessment for comparative clinical effectiveness and value. Betibeglogene autotemcel (Zynteglo/LentiGlobin) from [...]
Insurers Refuse to Pay for New Alzheimer’s Drug Without Evidence of Efficacy
Twenty-five major insurers will not pay for Biogen’s Alzheimer’s drug Aduhelm without further proof of efficacy, according to results from [...]
ISPOR Calls for Nominations for President-Elect of their 2022-2023 Board of Directors
ISPOR is seeking nominations for president-elect on the 2022-2023 ISPOR Board of Directors. In addition, there will be three vacancies [...]
EMA Issues Guideline on RWE in Registry-Based Studies
The European Medicines Agency (EMA) has released new guidelines for using and generating RWE in registry-based studies. The guideline highlighted [...]
xCures Releases xDECIDE Platform to Personalize Cancer Care Using RWD
Released earlier this month, the xDECIDE platform helps doctors choose the optimal treatment strategy for cancer patients, according to a [...]
Changing Dynamics Between NICE and Pharmaceutical Industry
Recent shifts in the UK’s National Institute for Health and Care Excellence’s (NICE) approach to health technology assessment (HTA) are [...]
Impacts of the Build Back Better Act on the Healthcare Industry
With the Build Back Better Act inching through the legislature, uncertainty is building regarding its effects on the healthcare industry. [...]
Interview with Scott Gottlieb on COVID, the CDC, and More
Gottlieb Scott Gottlieb, former CDC director, sat down for an interview with Stat News to discuss his new [...]
Call for Papers: Journal of Healthcare Quality 2022 Special Issue
The Journal of Healthcare Quality is seeking manuscripts for its upcoming special issue, “Addressing Disparities to Promote Health Equity and [...]
Clinical Research News Podcast Discusses Solara and LiveSLR
The impact of Cytel’s Solara and LiveSLR technologies on the relationship between forecasting and evidence technology is examined on the [...]
Avoiding Medical Bankruptcy with Quizzify Prevent Consent Clause
Half of all Americans have outstanding medical debt, and the same number cannot afford a medical emergency. Bills for emergency [...]
Upcoming ICER Webinar Will Discuss Barriers to Fair Access
On December 3rd (12 PM), the Institute for Clinical and Economic Review will host a public webinar detailing the findings [...]
HTA Submissions and Single-Arm Trials: An ISPOR EUROPE Panel Presentation
On December 2nd (11 AM to 12 PM), the use of single-arm trials for Health Technology Appraisal (HTA) will be [...]
Cerner Database Reveals COVID Death Rate Lower When Taking SSRIs
COVID Death Rate Lower When Taking SSRIs Electronic health records (EHR) from the Cerner Real World COVID-19 de-identified database indicate [...]
Rare Disease Cures and Person-Level Real-World Data
A freshly-launched webinar series from the Rare Disease Cures Accelerator–Data and Analytics Platform (RDCA-DAP®) reports how person-level data influences drug [...]
Lessons from RWE Demonstration Projects
Real-world evidence (RWE) demonstration projects are instrumental for global health technology assessment (HTA) organizations developing standards for the generation and [...]
Germany’s Digital Healthcare Act and Real-World Evidence
Germany's 2019 Act to Improve Healthcare Provision through Digitization and Innovation has accelerated the implementation of digital health applications (DiGa). [...]
Value-based Analysis of Telehealth in the US
Telehealth has rapidly expanded in recent years and is offered by up to 60% of care providers. This increase is [...]
Jeeva Informatics eClinical Platform Improves Trials
The founder and CEO of Jeeva Informatics, Harsha Rajasimha, maintains that clinical trials are held back by inefficiency and inadequate [...]