LONDON – A population level study tracking every pregnancy in Scotland between the start of the pandemic in March 2020 and the end of October 2021 lays bare the devastating impact of COVID-19 on perinatal mortality.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abivax, Ascendis, Atai, Basilea, Cellular, Denali, Edesa, GSK, Hutchmed, Jeil, Mitsubishi, Novavax, Pharmather, Rockwell, SK, Vir.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alar, Arrowhead, Blade, Cyteir, Glaukos, I-Mab, IMV, Mesoblast, Pfizer, Revolution, Vaxxinity, Zai Lab.
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) released guidance for sponsors and manufacturers on regulatory requirements for software to be used with COVID-19 rapid antigen self-tests that are intended to analyze and interpret tests results.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abiomed, Caredx, Castle Biosciences, Electrocore, Glaukos, Pictor.
LONDON – There was a marked increase in the projected return on investment in pharma R&D in 2021, which rose to 7%, the highest level since 2014. That was up from a lowly 2.7% in 2020 and – even worse – 1.8% in 2019, according to the 12th annual report tracking ROI by the consultants Deloitte. But while 7% is a significant improvement, it is still below the projected ROI when the first edition of ‘Measuring the Return from Pharmaceutical Innovation’ was published in 2010, in response to concerns that pharma was spending more and more on R&D while getting less out. At that point, projected ROI was 10.1%.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aramis, Artelo, Biomica, Immunome, Phio, Polynoma, Snipr, Vertex, Wesana.
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