The body of real-world evidence around Covid-19 continues to build, and a study released Aug. 26 in The Lancet points to concerning long-term effects for hospital survivors at the one-year mark.
For more than 50 years, randomized controlled trials (RCTs) have been used by the biopharmaceutical industry and regulators to evaluate the efficacy and safety of new medications as well as medical products that are being repurposed for new uses. But regulators and biopharmaceutical companies are being pushed to modernize their approaches to expedite drug development, which has resulted in increased attention to potential contributions of real world evidence (RWE).
Lifebit Biotech Ltd. announced the beginning of a long-term partnership with Boehringer Ingelheim to utilize Natural Language Processing (NLP) and Artificial Intelligence (AI) for the detection and early reporting of global disease outbreaks using real-world data harvested from scientific publications and other open sources.
CVS Health announced a new Clinical Trial Services business that brings together innovation and experience, driving greater access to clinical trials across the communities the company serves and creating a more efficient, convenient experience to improve participant retention and research effectiveness.
Health tech company Aetion and the U.S. Food and Drug Administration signed a collaboration agreement to use real-world data to advance the understanding of and response to COVID-19.
The U.S. Food and Drug Administration gave the green light to Sanofi’s Sarclisa (isatuximab-irfc) in combination with pomalidomide and dexamethasone (pom-dex) for adults with multiple myeloma who have had two previous therapies including lenalidomide and a protease inhibitor.
Shares of Karyopharm Therapeutics soared after the company posted positive Phase III results in multiple myeloma and announced plans for a regulatory submission in the second quarter of 2020 for a combination of Xpovio, Velcade and Dexamethasone.
Parexel will tap into real-world data to connect the biopharmaceutical services provider to data from the company’s clinical trials through a multi-year partnership with Bay Area-based Datavant.
Syapse, which accelerates precision medicine through insights derived from the company’s global health system network, announced a strategic collaboration with Pfizer Inc. to advance cancer outcomes research using real-world evidence toward the ultimate goal of improving patient health.
Clinical-stage immuno-oncology company Forty Seven Inc. announced a collaboration with Acerta Pharma, AstraZeneca’s hematology research and development center of excellence.