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BioWorld - Wednesday, July 16, 2025
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Regulatory actions for August 10, 2023

Aug. 10, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accuray, Motus GI Holdings, Nevro.
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FDA approved icons and medical professional

Class, group, member: J&J gets (bi)specific in r/r MM with Talvey approval

Aug. 10, 2023
By Randy Osborne
The accelerated clearance won by Johnson & Johnson (J&J) from the U.S. FDA for Talvey (talquetamab-tgvs) for relapsed or refractory multiple myeloma (r/r MM) in adults brings to the market the bispecific antibody that takes aim at G protein-coupled receptor class C group 5 member D, a target of interest to other developers as well.
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Vaccination
Infection

Lemonex receives approval of IND application for LEM-mR203

Aug. 10, 2023
Lemonex Inc. announced that the IND application for its mRNA vaccine candidate LEM-mR203 has been approved by the Korean Ministry of Food and Drug Safety (MFDS) on July 21, 2023. The company plans to evaluate LEM-mR203 as potential treatment for COVID-19, with the planned phase I clinical trial being designed to assess its safety and immunogenicity in healthy adults at Seoul National University Hospital, Korea.
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Antibodies attacking cancer cell
Immuno-oncology

FDA clears Georgiamune’s IND application for GIM-122

Aug. 10, 2023
Georgiamune Inc. announced that the FDA cleared its IND application for GIM-122, a first-in-class dual-functioning monoclonal antibody designed to target a highly novel mechanism to overcome immunotherapy resistance.
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Regulatory actions for Aug. 9, 2023

Aug. 9, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aleta, Aspen, Biophytis, Lisata, Novartis, NS, Puma.
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FDA’s final guidance for device software functions tightens requirements for anomalies

Aug. 9, 2023
By Mark McCarty
The U.S. FDA’s final guidance for premarket submissions for device software functions serves as a much needed overwrite of a badly outdated policy but includes some significant changes over the legacy guidance. There are also a few changes between the 2021 draft and the 2023 final guidance, however, such as a call for more details about how software anomalies were discovered and what a root cause analysis would suggest about the origin of the anomaly.
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Sickle cell disease

Trinity Biotech gets FDA nod for hemoglobin diagnostic system

Aug. 9, 2023
By Shani Alexander
Trinity Biotech plc. received U.S. FDA 510(k) clearance for its lab-based hemoglobin diagnostic system, the Premier Resolution system, which the company hopes will allow it to regain its market leading position in hemoglobin variant detection. The Premier Resolution system is an automated analyzer which quantifies fetal hemoglobin and hemoglobin A2 and detects more than 200 hemoglobin variants. The device is a modern successor to the company’s Ultra system which once held a leading position in the U.S. hemoglobin variant diagnostic market.
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Regulatory actions for August 9, 2023

Aug. 9, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Boston Scientific, Curiteva, Theranica Bio-Electronics.
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Vaccine vial and syringe

New UK vaccine center targeting pandemic-potential pathogens

Aug. 8, 2023
Building on capabilities developed during the COVID-19 pandemic, the U.K. Health Security Agency’s Vaccine Development and Evaluation Centre hit the ground running.
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Advanz still on UK hook for excessive Rx price increases

Aug. 8, 2023
Calling it a “landmark judgment,” the U.K.’s Competition and Markets Authority welcomed the Competition Appeal Tribunal’s Aug. 8 unanimous decision upholding an £84 million (US$107 million) fine levied against London-based Advanz Pharma Corp. for excessive drug pricing.
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