Blog Post by Admin
Article
Aug 25, 2021
Could Synthetic Data be the Future of Data Sharing?
This article in CPO Magazine explores the rise of synthetic data generation (SDG) as a ...
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Blog
Aug 12, 2021
Patient voice in RWE: Generating evidence that will impact payer and HTA decision-making
With the rise of patient-centered medicine and accelerated approvals, health technology ...
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FDA Decision Alert
Aug 12, 2021
CDER-Approved NDA for LUMAKRAS™ (sotarasib)
On May 28, 2021, FDA granted Accelerated Approval to Amgen’s LUMAKRAS™ (sotarasib) for ...
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FDA Decision Alert
Aug 12, 2021
CBER-Approved sBLA for KEDRAB® (rabies immune globulin (human))
On May 17, 2021, FDA approved an sBLA for Kamada’s KEDRAB® (rabies immune globulin ...
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Blog
Aug 5, 2021
RWE Guidance Watch: IMPACT HTA publishes recommendations on the use of RWE in HTA
As researchers await comprehensive guidance on the use of real-world evidence (RWE)—and ...
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Blog
Jul 29, 2021
An update on efforts to standardize and democratize RWE: Q&A with Dr. Nirosha Mahendraratnam Lederer
As real-world evidence (RWE) adoption continues to ramp up across health care, ...
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Blog
Jul 22, 2021
Research spotlight: Gilead Sciences and Aetion use RWE to assess the comparative effectiveness of remdesivir for COVID-19
As COVID-19 continues to evolve, frontline health care workers are eager for real-world ...
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FDA Decision Alert
Jul 19, 2021
CBER-Approved BLA for ABECMA® (idecabtagene vicleucel)
On March 26, 2021, FDA approved Celgene’s BLA for ABECMA® (idecabtagene vicleucel) for ...
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FDA Decision Alert
Jul 9, 2021
CDER-Approved sBLA for ERBITUX® (cetuximab)
On April 6, 2021, FDA approved a new biweekly dosing regimen for Eli Lilly’s ERBITUX® ...
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Blog
Jul 8, 2021
Using RWE to characterize diseases as novel treatments become available: Q&A with Dr. Maria Schneeweiss
As novel therapies come to market, especially in disease areas that aren’t as well ...
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Blog
Jul 2, 2021
Research spotlight: Using RWD sources to describe the patient burden of a poorly understood rare disease
This month, Aetion and Boehringer Ingelheim published two co-authored papers which ...
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Jun 24, 2021
CDER-Approved NDA for LAMPIT® (nifurtimox)
On August 6, 2020, FDA granted accelerated approval to Bayer Healthcare’s LAMPIT® ...
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Presentation
Jun 17, 2021
Implementing the FAIR Data Sharing Principles
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Presentation
Jun 16, 2021
Experiences Implementing Data Synthesis in a Global Life Sciences Company
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Presentation
Jun 16, 2021
Data Synthesis: A Tool for Responsible Data Sharing
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Blog
Jun 10, 2021
Research spotlight: Organized structure of RWE best practices
In the last five to 10 years, stakeholders from around the globe have launched ...
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Blog
May 25, 2021
How NICE is approaching guidelines for RWE generation: Q&A with Dr. Páll Jónsson
In its recently announced five-year strategy, the UK’s National Institute for Health and ...
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Blog
May 20, 2021
Introducing the RWE Alliance: How a cross-industry coalition aims to advance RWE policy
The last several years have been foundational in the effort to advance the use of ...
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Blog
May 13, 2021
How leading-edge teams are using RWE to accelerate drug development: A conversation with Janssen R&D and Sanofi
The majority of biopharma organizations are investing in real-world evidence (RWE) ...
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Blog
May 6, 2021
How payers and providers can leverage RWE: Q&A with Bill Guptail, SVP of Value-Based Care, Aetion
As payers and providers continue to navigate value-based agreements and strive to improve ...
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Publication
May 1, 2021
Evaluating the Utility of Synthetic COVID-19 Case Data
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Blog
Apr 29, 2021
How using an RWE platform can support building regulatory-grade ECAs
An external control arm (ECA) study is a cutting-edge pharmacoepidemiologic design that ...
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Blog
Apr 22, 2021
RWE plays an integral role in NICE’s five-year strategy
For the UK’s National Institute for Health and Care Excellence (NICE) the COVID-19 ...
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Blog
Apr 15, 2021
How RWE can support safety in Europe: Dr. Pierre Engel on leveraging innovative strategies to meet regulatory requirements
In Europe as in the U.S., biopharma organizations, regulators, and health technology ...
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