Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Flowvision, Qiagen.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alivecor, Thermo Fisher Scientific, Vect-horus.
The FDA’s attempts to thwart the use of electrostimulation devices for self-injurious and aggressive behavior came up short in an appeals court hearing of Rotenberg v. FDA, largely because the FDA’s approach suggested the agency would control the practice of medicine.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Hyalex Orthopaedics, Seaspine.
The U.S. Federal Trade Commission (FTC) reported a series of moves recently that promise more scrutiny of companies in the life sciences industry, such as the more routine use of subpoenas and other compulsory processes during investigations. However, the FTC has also announced a broader revamp of the agency’s rulemaking authorities that some critics argue would allow the commission to promulgate rules that are in defiance of standing FTC practice.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cytosorbents, Insightec, Siemens Healthineers.
Patent protection in China has been a point of concern for device makers for some time, but so has patent piracy. The Peoples Republic of China has issued some amendments to its patent law that allow for adjustments and extensions to the term of a patent, changes that are a welcome bit of news for companies in the life sciences.
The FDA has given a green light to Foundation Medicine Inc.’s Foundationone CDx as a companion diagnostic for Takeda Pharmaceutical Co. Ltd.’s Alunbrig to identify patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small-cell lung cancer (NSCLC). The approval comes as Laboratory Corp. of America Holdings (Labcorp) is launching a companion diagnostic to identify NSCLC patients with the KRAS mutation. NSCLC accounts for about 85% of all lung cancers, with an estimated 1.8 million new cases diagnosed each year worldwide. Of those, 3% to 5% carry the ALK gene mutation, which is often missed with standard testing methods.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biogx, Foundation Medicine, Sonoscape Medical.
The World Health Organization’s (WHO) guidance for ethics and governance for artificial intelligence (AI) in health discusses several issues regarding regulation, including the question of transparency for the algorithm’s source code. The WHO paper is not prescriptive on this and several other issues, however, raising the prospect that regulatory entities will not be discouraged from adopting policies that run afoul of intellectual property concerns and thus impede advances in AI.
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