REGULATORY : Is It Safe to Outsource Safety? Waiving Inclusion/Exclusion Criteria CRO/SPONSOR : Metrics - The Pitfalls of Over Collection SUBJECT RECRUITMENT : Trial Results Provided to Volunteers in Pilot Program Also in this issue : New Reform Law Requires Fee Disclosure, GCP Standards in Global Trials, A Learning Healthcare System, The Physician Payments Sunshine Act
Phase III Trial of Keytruda Plus Lynparza for NSCLC Stopped Due to Futility
December 7th 2023KEYLYNK-008 trial finds that Keytruda in combination with chemotherapy followed by Keytruda plus Lynparza did not produce an improved overall survival benefit in patients with metastatic squamous non-small cell lung cancer.
Key Phase III Trial Results Lead to FDA Approval of Fabhalta for Paroxysmal Nocturnal Hemoglobinuria
December 6th 2023Clinical trials demonstrated superiority of Fabhalta to anti-C5s in hemoglobin improvement in the absence of transfusions and transfusion avoidance rate, showing clinically meaningful hemoglobin-level increases without the need for blood transfusions in patients with paroxysmal nocturnal hemoglobinuria.