Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Clearmask, Diazyme, Genosity, Illuminoss, Sensiva.
Keeping you up to date on recent developments in oncology, including: New and less expensive approach to digital PCR may improve cancer detection; Stromal cell subtypes identified in TNBC; Microbiome metabolites as immunotherapy adjuvants; Pandemic significantly impeded breast cancer follow-up.
LONDON – A pan-European consortium backed by 11 pharma companies is pooling resources in a €77.7 million (US$92.5 million) five-year plan to advance development of therapeutics for COVID-19 and other coronaviruses.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Emmaus, Immatics, Kimera, Krystal.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acepodia, Aligos, Arrowhead, Clovis, Deciphera, Follicum, GSK, Immatics, Immunicum, Immutep, Intravacc, Maxcyte, Novartis, Organicell, Poseida, Telix, The University of Texas MD Anderson Cancer Center, Ultimovacs, Vanda.
The COVID-19 pandemic has spurred a considerable amount of testing innovation, including more extensive use of saliva as a medium for detection of pathogens. The U.S. FDA has announced an emergency use authorization (EUA) to Yale School of Public Health for the Salivadirect testing protocol that requires no extraction of the SARS-CoV-2 virus’s RNA, a feature that Assistant Secretary for Health Brett Giroir said is “yet another testing innovation game changer that will reduce demand for scarce testing resources.”
LONDON – A large scale population study has shown that home self-testing with low-cost lateral flow diagnostics is a valid way of tracking the COVID-19 pandemic. A total of 105,651 people across the U.K. tested themselves for SARS-CoV-2 antibodies with a fingerprick blood test as part of the REACT (REaltime Assessment of Community Transmission) study.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Becton Dickinson, Cartiva, C.R. Bard, Stryker ENT.
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