Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Dompé, Mesoblast, Mustang, Oblato, Pharmacyte.
PERTH, Australia – After its initial public offering on the Australian Securities Exchange, soft tissue regeneration company Aroa Biosurgery Ltd. has received new clearances in the U.S. and Europe and is focusing on building up its commercial and manufacturing capacity.
The latest global regulatory news, changes and updates affecting biopharma, including: Department of Justice, Dusa, FDA, Michbio, Russian Ministry of Health, SEC, Stericycle Expert Solutions, Wintac.
The U.S. FDA has given the green light to Roche Group for its Cobas HIV-1/HIV-2 Qualitative test for use on Cobas 6800 and 8800 systems. The test is the first FDA-approved, fully automated polymerase chain reaction (PCR) test that detects and differentiates between human deficiency virus type 1 (HIV-1) and HIV-2, as well including claims for pregnant women and children.
TORONTO – Its Canadian medical device establishment licence now firmly in hand, Toronto-based Internet of Things Inc. (ITT) is set to launch a fever-detection system for identifying possible COVID-19 carriers at the entrances of airports, long term care facilities, schools and other places where people congregate. The Thermalpass is an AI-enabled, deep learning screening system that got its start as a road-related weather sensing system, today detecting elevated body temperature.
With a potential COVID-19 vaccine moving closer to reality and the U.S government signing contracts for millions of potential doses, an unresolved question is who should be at the front of the line to get those first doses.
The first weekly therapy for adult growth hormone deficiency (GHD) has arrived in the U.S. with FDA approval for Novo Nordisk A/S' Sogroya (somapacitan). It’s the first of Novo's regulatory filings for the medicine, also submitted in the EU and Japan, to win approval. Sogroya replaces endogenous growth hormone in adults who don't produce enough of it. Novo said it is working to finalize plans to make the therapy available and has not yet disclosed pricing.
Two days ahead of its Sept. 3 PDUFA date, Bristol Myers Squibb Co. received the FDA’s approval for Onureg, an oral form of azacitidine, for continuing treatment of adults with acute myeloid leukemia (AML). The indication is specifically for patients achieving first complete remission (CR) or CR with incomplete blood count recovery following intensive induction chemotherapy and who are not able to complete intensive curative therapy. BMS said Onureg is the first and only FDA-approved continued AML treatment for patients in complete remission.
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