U.S. lawmakers have been busy writing to government agencies demanding answers and explanations on a range of issues, including drug shortages, gain-of-function research and thickets of duplicative patents that extend patent protection well beyond 20 years for some prescription drugs.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ARS, BMS, CSL, Ionctura, Maat, Thermosome, Tiziana.
The U.S. FDA gave Bot Image Inc. a coveted threefer with 510(k) clearance for its Prostatid artificial intelligence (AI) software for detection, diagnosis and monitoring of prostate cancer using both standard MRI and a non-invasive bi-parametric MRI, which does not require a contrast agent.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bot Image, Icecure Medical, Q'Apel Medical, Vaporox.
China’s NMPA granted conditional approval for a COVID-19 oral pill to treat adult patients with mild to moderate cases of the virus to a unit of Guangdong Zhongsheng Pharmaceutical Co. Ltd.
Japan’s PMDA has approved Aurion Biotech Inc.’s cell therapy, Vyznova, for the treatment of bullous keratopathy of the cornea, making it the first-ever approval of a cell therapy to treat corneal endothelial disease.
CSPC Pharmaceutical Group Ltd.’s COVID-19 mRNA vaccine, SYS-6006, has been included for emergency use by the NMPA, the company said on March 22, marking the first domestically developed COVID-19 mRNA vaccine approved for use in China.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amicus, Brainstorm Cell, Cyclerion, Genentech, Incyte, Iovance, Oncology.
Mergers and acquisitions in the U.S. have been under tremendous regulatory pressure over the past two years, a trend that seems likely to continue for the foreseeable future. However, Lina Khan, chairwoman of the U.S. Federal Trade Commission (FTC), said in a March 27 public forum that the agency will not wait for airtight cases to pursue legal remedies in part because the perfect case does not always arise, but also because the courts can be provoked into validating a novel legal theory even if the court does not ultimately side with the FTC.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Femdx Medsystems, Getinge.
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