Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Inex Innovate, Neuronetics.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Eisai, Gilead, Kadmon, Moleculin, Neogene, Novo Nordisk, Turning Point, Zai Lab.
The in vitro diagnostics industry has turned in an impressive response to the COVID-19 pandemic, but a few problems are bound to surface. The U.S. FDA reported May 10 that the Accula test by San Diego-based Mesa Biotech Inc. has been recalled due to contamination of test materials at the manufacturing site, a problem that could lead to false negative findings with the test.
The Medical Device Innovation Consortium (MDIC) ran a series of 14 test cases to evaluate the value of real-world evidence (RWE) for regulatory decision making, but there were several sources of drag in this first phase of the project, such as a lack of availability of unique device identifiers (UDIs) for some devices.
News of government prosecutors actively going after individuals for defrauding the U.S. health care system has become commonplace, but the government’s focus on criminally prosecuting fraud against Medicare, Medicaid and other government programs could make biopharma companies’ patient assistance programs a more attractive target.
A proposal hammered out by the EU, India, South Africa and the U.S. to allow IP waivers for COVID-19 vaccines is headed to all members of the World Trade Organization (WTO) for consideration.
A congressional investigation into COVID-19 vaccine manufacturing failures at Emergent Biosolutions Inc. unveiled more troubling issues at the company’s Bayview facility in Baltimore, which had been awarded a lucrative U.S. government contract to produce vaccines for Johnson & Johnson.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acer, Elpiscience, Logicbio, Resverlogix, Selection, Teva, Therapeutics Solutions.
The U.S. FDA reported it is evaluating the potential for exposure to some chemicals associated with the use of several models of hemodialysis machines made by Fresenius Medical Care Inc., of Waltham, Mass., including units that are no longer in production.
Cvrx Inc. secured U.S. FDA approval for magnetic resonance-conditional labeling for its Barostim system, a neuromodulator that improves symptoms of patients with heart failure. With the latest approval, patients with the implanted system can have magnetic resonance imaging (MRI) at 1.5T under the specified conditions.
RSS
