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Home » Topics » Regulatory

Regulatory
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Red wooden approved stamp

Shionogi scores emergency approval for Japan’s first domestic COVID-19 oral antiviral

Dec. 13, 2022
By Tamra Sami
Shionogi & Co. Ltd.’s orally administered COVID-19 antiviral, 3CL protease inhibitor Xocova (ensitrelvir/S-217622), scored emergency regulatory approval from Japan’s Ministry of Health, Labor and Welfare for SARS-CoV-2 infection, and the Japanese government has agreed to purchase 1 million courses of Xocova for domestic supply of the antiviral.
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Regulatory actions for Dec. 13, 2022

Dec. 13, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agilent, Axonics, Eyenovia, Mediwound, Qiagen.
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COVID-19 vaccine and syringe with flag of China

China grants emergency use of new vaccines as it eases COVID-19 policy

Dec. 13, 2022
By Doris Yu
China recently approved four COVID-19 vaccines for emergency use in a span of two days. The nods were granted to Clover Biopharmaceuticals Ltd., Sinocelltech Group Ltd., Beijing Wantai Biological Pharmacy Enterprise Co. Ltd. and Westvac Biopharma Co. Ltd. There is still no mRNA vaccine approved in the country.
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Regulatory actions for Dec. 13, 2022

Dec. 13, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Brainstorm, Evergreen, Galera, Ideaya, Janssen, Medivir, Pfizer, Recce, Sobi, Vertex.
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Blue heart and data grid

Cytokinetics hoping for good adcom review of heart failure drug

Dec. 12, 2022
By Mari Serebrov
What could be Cytokinetics Inc.’s first approved drug will take center stage Dec. 13 at a meeting of the U.S. FDA’s Cardiovascular and Renal Drugs Advisory Committee. But judging from the FDA’s briefing document for the meeting, the spotlight on the heart failure drug, omecamtiv mecarbil, could be harsh.
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Regulatory actions for Dec. 12, 2022

Dec. 12, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Irras, RF Medical.
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Regulatory actions for Dec. 12, 2022

Dec. 12, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alnylam, Antengene, Biogen, Braeburn, Janssen, Pfizer, Recce.
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Regulatory actions for Dec. 9, 2022

Dec. 9, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akero, Bioxytran, Bloomsbury Genetic, Brim, Cerecin, Emmaus, In8bio, Liscure, Moderna, Molecular Targeting, Numinus, Quralis, Takeda, VBI, Visiox, Y-mabs.
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OIG sees issues with COVID-related add-on diagnostic testing

Dec. 8, 2022
By Mark McCarty
The U.S. Office of Inspector General examined the volume of tests for allergies and respiratory pathogens conducted during the COVID-19 pandemic, and found a few outlier testing labs that billed a conspicuous volume of such tests. While the agency recommended that the CMS examine these claims more closely, the results also suggest that enforcement action may be en route for the more than 160 labs identified as having filed a higher than typical volume of claims for these tests.
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2022 FDLI Enforcement Conference

Theranos convictions highlight role of fraud allegations in prosecutions of life science firms

Dec. 8, 2022
By Mark McCarty
The conviction and sentencing of Elizabeth Holmes and Sunny Balwani of Theranos Corp. might be seen as an example of retribution for testing technology that didn’t exist and thus endangered patients, but that perception doesn’t stand up to scrutiny.
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