News from the healthcare data industry
President Joe Biden is expected to pick cancer surgeon Monica Bertagnolli as the next director of the National Cancer Institute (NCI). Bertagnolli, a physician-scientist at the Dana-Farber Cancer Institute in Boston and Harvard Medical School, specializes in gastrointestinal cancers and is well known for her expertise in clinical trials. She…
EMA has endorsed a joint statement calling for international collaboration to enable the generation and use of real-world evidence for regulatory decision-making published today by the International Coalition of Medicines Regulatory Authorities (ICMRA). The use of real-world data and real-world evidence in the development, authorisation and monitoring of medicines to support regulatory decision-making…
As more and more biotechs are looking into the potential applications of using real-world evidence in regulatory submissions, the European Medicines Agency is calling for more widespread adoption. EMA endorsed a statement published Friday by ICMRA, the International Coalition of Medicines Regulatory Authorities, highlighting the use of both RWE and…
Executive Summary In the face of rapid innovation, a strong need exists for improved evidence generation capabilities to answer critical questions faced by regulators and payers. Systematically collecting real-world data to generate real-world evidence may provide the means to supplement the evidence available for newly approved novel therapies. Under the…
Amazon is acquiring One Medical for $18 a share, an all-cash deal that values the primary health-care provider at roughly $3.9 billion, the companies said Thursday. The deal deepens Amazon’s presence in health care, which Neil Lindsay, senior vice president of Amazon Health Services, said is “high on the list of experiences that need reinvention.”…
By Raymond Chan, Tsubasa Itani, Tomoko Nagatani, Michele Raviscioni, and Atsushi Sorita Pharmaceutical companies have long been using real-world evidence (RWE) to inform their decision making, respond to requests from external stakeholders, improve their therapies and, more recently in some jurisdictions, to gain regulatory approval for new treatments. The use of advanced analytics to…
Published in PNAS Nexus, this study has the ability to impact future research and inform more proactive and sustainable pandemic preparedness July 20, 2022 08:47 AM Eastern Daylight Time CAMBRIDGE, Mass.–(BUSINESS WIRE)–nference, an AI-driven health technology company, today announced a new research partnership following the publication of a study demonstrating…
DURHAM, N.C., July 20, 2022 /PRNewswire/ — New data from Target RWE‘s TARGET-PBC cohort found that pruritis (itching) was reported in 81% of patients with Primary Biliary Cholangitis (PBC), with those reporting clinically significant pruritus (30%) scoring worse on each domain of the PBC-40 and 5-D itch, more frequently having cirrhosis, and having…
At UCB, we see the many benefits of integrating technology in all aspects of our business to amplify the power of scientific innovation and to improve patient care. In the second UCB Digital Health Roundtable (June 2022) an expert panel discussed how clinical research, and the data we use within…
DURHAM, N.C., July 20, 2022 /PRNewswire/ — New data from Target RWE‘s TARGET-PBC cohort found that pruritis (itching) was reported in 81% of patients with Primary Biliary Cholangitis (PBC), with those reporting clinically significant pruritus (30%) scoring worse on each domain of the PBC-40 and 5-D itch, more frequently having cirrhosis, and having…