Ethris GmbH has received approval from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) to proceed with a first-in-human trial of its inhaled mRNA program, ETH-47, in healthy participants for the treatment and prophylaxis of respiratory viral infections.
CSPC Pharmaceutical Group Ltd.’s selective son of sevenless homolog 1 (SOS-1) inhibitor SYH-2038 has received clearance by China’s National Medical Products Administration (NMPA) to enter clinical trials in China.
With U.S. drug prices a perennial issue, several lawmakers, both Democrats and Republicans, are increasingly looking beyond biopharma to identify other “persons of interest” that may be complicit in the high list prices facing American patients.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 4D Medical, Awak, Brainspec.
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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Baird Medical.
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.
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.
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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