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Regulatory actions for Nov. 27, 2023

Nov. 27, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 4D Medical, Awak, Brainspec.
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Silhouettes
Neurology/Psychiatric

Neumora’s M4 receptor positive allosteric modulator enters clinic for schizophrenia

Nov. 27, 2023
Neumora Therapeutics Inc. has announced IND clearance and initiation of a phase I study of NMRA-266 in healthy adults.
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Antibody-drug conjugate
Immuno-oncology

Henlius’ EGFR-targeting ADC receives FDA clearance to enter clinic for solid tumors

Nov. 24, 2023
Shanghai Henlius Biotech Inc. has announced IND approval by the FDA for HLX-42 for injection, an antibody-drug conjugate (ADC) developed under a collaboration between Henlius and Medilink Therapeutics.
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Regulatory actions for Nov. 22, 2023

Nov. 22, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Baird Medical.
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US FTC hits gene testing firm for claims related to ancestry testing

Nov. 22, 2023
By Mark McCarty
The U.S. Federal Trade Commission announced Nov. 21 that it has obtained a civil monetary penalty in the amount of $700,000 from CRI Genetics LLC, an enforcement action taken under the agency’s policy for biometrics information.
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US FTC seeks yet more broad AI investigative authority

Nov. 22, 2023
By Mark McCarty
The U.S. Federal Trade Commission is clearly a more activist agency of late, although much of that activism has been around mergers and acquisitions. The latest FTC move, however, deals with investigative authorities that will be applied toward artificial intelligence (AI), which Katie Bond of Keller & Heckerman LLP said will give the agency considerable powers of discovery regardless of the merits of the enforcement action.
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Laptop displaying FDA logo

FDA clears 4dmedical’s CT lung ventilation analysis software

Nov. 22, 2023
By Tamra Sami
The U.S. FDA cleared respiratory imaging technology company 4dmedical Ltd.’s computed tomography lung ventilation analysis software (CT LVAS) that is nearly identical to its X-ray velocimetry technology but uses CT imaging and provides greater access to the four-dimensional imaging technology.
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Polaris begins rolling BLA for ADI-PEG 20 for pleural mesothelioma

Nov. 21, 2023
By Tamra Sami
Polaris Pharmaceuticals Inc. has submitted the first part of its rolling BLA to the FDA for lead product, ADI-PEG 20, for systemic treatment of patients with malignant pleural mesothelioma with non-epithelioid histology in combination with a platinum agent and pemetrexed. The BLA is supported by the pivotal phase III Atomic study in which pegargiminase (pegylated arginine deiminase/ADI-PEG 20) met the primary endpoint of a statistically significant improvement in overall survival and the secondary endpoint of a significant improvement in progression-free survival in patients with malignant pleural mesothelioma.
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Rexulti television ad

FDA chides Otsuka for making false or misleading claims in Rexulti advertising

Nov. 21, 2023
By Tamra Sami
The U.S. FDA’s Office of Prescription Drug Promotion is calling out Otsuka Pharmaceutical Co. Ltd. for making “false or misleading claims and representations about the efficacy of Rexulti” in a television advertisement.
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Regulatory actions for Nov. 21, 2023

Nov. 21, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Foundation Medical, GE Healthcare, Medtronic, Pixyl, Supira Medical.
Read More
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