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BioWorld - Saturday, June 7, 2025
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Regulatory
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Regulatory actions for April 6, 2022

April 6, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amniotics, BMS, CNS, Starton, Tiziana.
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Merck tax reporting under US Senate microscope

April 5, 2022
By Mari Serebrov
As part of an investigation into the international provisions of the U.S. 2017 tax law, Sen. Ron Wyden (D-Ore.) is zeroing in on how Merck & Co. Inc. was able to report 14% of its pre-tax income in the U.S. when nearly half of its global sales were in the country.
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U.S. health compass

Senators: Time to plan for the beginning of the end of US health emergency

April 5, 2022
By Mari Serebrov
Even as many in the U.S. are looking for the end of the COVID-19 public health emergency, Health and Human Services (HHS) Secretary Xavier Becerra reinforced expectations April 5 that he will continue the emergency declaration into the summer, if not beyond. When asked during a Senate Finance Committee budget hearing if he saw the emergency ending this summer, Becerra declined to give a date, but reiterated his commitment to give stakeholders at least 60 days’ notice.
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Regulatory actions for April 5, 2022

April 5, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ariste Medical, Baxter, Bearpac Medical.
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Japan rolls out higher than average 32 approvals in March to close out fiscal year

April 5, 2022
By Gina Lee
Japan’s Ministry of Health, Labour and Welfare finished the first quarter – and Japan’s fiscal year – with a bang, handing out 32 approvals in the month of March. It marked a massive jump from previous months, which saw 13 products approved in February 2022 and 12 in January 2022. A total of nine products were approved in December 2021.
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Regulatory actions for April 5, 2022

April 5, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accutar, Acer, Alnylam, Ascletis, Blade, Cansino, Curis, Immunitybio, Immunocore, Janssen, Junshi, JW, Kite, Nobelpharma, Precigen, Regeneron, Roche, Sanofi.
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Japan rolls out higher than average 32 approvals in March to close out fiscal year

April 4, 2022
By Gina Lee
Japan’s Ministry of Health, Labour and Welfare finished the first quarter – and Japan’s fiscal year – with a bang, handing out 32 approvals in the month of March. It marked a massive jump from previous months, which saw 13 products approved in February 2022 and 12 in January 2022. A total of nine products were approved in December 2021.
Read More

Patient death leads to a partial clinical hold for Curis

April 4, 2022
By Lee Landenberger
A patient’s death has prompted the FDA to place a partial clinical hold on Curis Inc.’s phase I/IIa study of emavusertib in leukemia. The patient, who had relapsed or refractory acute myeloid leukemia, experienced several conditions. One of them was rhabdomyolysis, a dose-limiting toxicity of emavusertib. Rhabdomyolysis is a breakdown of muscle fibers in the blood.
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Regulatory actions for April 4, 2022

April 4, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biolytical Laboratories, Feops, GE Healthcare.
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Regulatory actions for April 4, 2022

April 4, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Finch, Merck & Co., Reata, Valenzabio, Y-mabs.
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