Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Albireo, Almirall, Aquestive, Astrazeneca, Bluerock, Elucida, G1, Kadmon, Kyowa Kirin, Lyndra, Merck & Co., Oblato, Receptor Life Sciences, Sinovac, Xenikos, Yisheng.
The Organization for Economic Cooperation and Development (OECD) announced a two-pillar plan for reform of international rules of taxation that would update rules said to be insufficient for the 21st Century economy. The proposal, a joint effort of the OECD and the G20, is to apply a minimum tax rate of 15% on goods shipped across national boundaries, thus putting an end to tax havens that have been used to avoid taxes.
The FDA is applying a good deal of resources toward a framework for regulation of artificial intelligence (AI) and machine learning (ML), but there are several sources of drag on those efforts. According to the FDA's Jana Delfino, one of these is that there is little agreement between regulators on a number of definitions, including the meaning of terms such as "validation," a problem she said must be solved if the field is to advance in a meaningful manner.
The FDA has granted breakthrough device designation to Endologix LLC for its Chimney Endovascular Aneurysm Sealing (ChEVAS) system. The device, which is intended for use in treating aortic aneurysms, is currently being evaluated in a multicenter pivotal study. The ChEVAS system is an endovascular abdominal aortic aneurysm (AAA) therapy designed to combine the Nellix 3.5 endograft with parallel visceral chimney stents to enable treatment of patients with juxtarenal, pararenal and suprarenal AAA.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Endologix, Nevro.
Regardless of the controversy swirling around the FDA’s accelerated approval of Biogen Inc.’s Alzheimer’s drug, Aduhelm, that U.S. approval is expected to open the door to more opportunities for Alzheimer’s treatments and diagnostics.
Apotex Corp. agreed to pay $26 million to the state of Texas to resolve claims that it had reported inflated drug prices to the Texas Medicaid program.
Six weeks ahead of its PDUFA date, Kadmon Holdings Inc.’s NDA for Rezurock (belumosudil) has been approved to treat chronic graft-vs.-host disease. The selective oral inhibitor of Rho-associated coiled-coil kinase 2, a daily treatment for patients 12 and older after failure of at least two prior lines of systemic therapy, is the New York-based company’s first approved therapy.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Astellas, Eli Lilly, Fibrogen, Hutchmed, Kintor.
Following the temporary lapse in FDA inspections of manufacturing sites amid the COVID-19 pandemic, this year has already seen more class I medical device recalls issued than in all of 2020. The agency is now working to remediate the interruptions resulting from the pandemic among certain manufacturers of high-risk medical devices in reporting these recalls to the FDA.
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