AMGEN INVESTS IN BIG DATA DEAL – REAL WORLD EVIDENCE
COMMENTS: Part of the growing trend for big pharma to secure bid data sources for their own use. IMPACT: A move in the right direction towards ‘regulatory grade’ RWE, READ Continue Reading
COMMENTS: Part of the growing trend for big pharma to secure bid data sources for their own use. IMPACT: A move in the right direction towards ‘regulatory grade’ RWE, READ Continue Reading
IMPACT: Taking insulin and a GLP-1 agonist significantly increases the ability of achievement stable blood sugar levels READ TIME: 2 mins * 1. “Sanofi’s Soliqua combines an insulin with a Continue Reading
Quick Notes: CONTEXT: RWD, RWE, Pfizer, Isaeli Government, Data Transparency, Real-World Epidemiological Evidence Collaboration Agreement IMPACT: Sharing of Real-World Epidemiological Evidence to improve understanding of impact of COVID-19 vaccination Time Continue Reading
Quick Notes: CONTEXT: USA, IVDs, RWE, Real-World Evidence Framework for regulatory decision-making for in vitro diagnostics (IVDs) IMPACT: step forward in providing the valuable information that IVD manufacturers and others Continue Reading
EXPERT NOTES: CONTEXT: EU, Commercial RWD Data Source IMPACT: Access to EU RWD, drive cutting edge improvements in patient outcome Time Taken = 3 mins QUOTES FROM SOURCE: 1. “NEW Continue Reading
EXPERT NOTES: CONTEXT: Peer Reviewed Data, RWE of Effectiveness of Cabozantinib IMPACT: In the largest real-world study to date, cabozantinib was effective in unselected, heavily pretreated patients with mRCC. Initiation Continue Reading
EXPERT NOTES: CONTEXT: Decentralized Clinical Trials IMPACT: Enabling technology for ‘Decentralized Clinical Trials’ a.k.a ‘Virtual Trials’ Time Taken = 2 mins QUOTES FROM SOURCE: 1. “As mentioned earlier, COVID-19 has Continue Reading
Quick Notes: CONTEXT: Japan, Real-World Data IMPACT: Acceptability of RWD in Regulatory Submissions Time to Read = 2 mins Quotes from Source: 1. “TOKYO — Japan’s health ministry will issue Continue Reading
Quick Notes: *Within the report the “conditional marketing authorisations” and “monitoring in real-life” are the “go to” section to see what the post-authorisation obligations were and what the EMA is Continue Reading