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.
The FDA reported a class I recall of the Wirion embolic protection device by Cardiovascular Systems Inc. (CSI), of St. Paul, Minn., due to reports of nine instances of device malfunction. The agency said the filter portion of the device can be difficult to withdraw under some circumstances and thus lead to separation, although the FDA noted that no deaths have been reported in association with the issue despite the risk of embolization. The FDA’s device center also posted a Jan. 11 notification against the use of two tests by Lusys Labs Inc., of San Diego, for the SARS-CoV-2 virus.
Where’s the plan? That was the underlying question Jan. 11 as Biden administration health officials faced frustration and tough questions from both Democrats and Republicans on the Senate Health, Education, Labor and Pensions (HELP) Committee about how the U.S. government is responding to the surge of COVID-19 infections caused by the omicron variant.
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