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Regulatory
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Regulatory actions for April 7, 2022

April 7, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aidoc, Arterys, Escala, Seegene.
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Regulatory actions for April 7, 2022

April 7, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascletis, Beigene, Bionecure, Bioxcel, Dialectic, GSK, Innovent, Iovance, Merck, Novartis, Sellas, Tonix, UCB, Vir.
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GAO, OIG drilling down into US federal health program payment for telehealth

April 6, 2022
By Mark McCarty
The spike in U.S.-based telehealth visits during the COVID-19 pandemic was greeted with cheers among advocates of the technology, but the Government Accountability Office (GAO) has advised the Centers for Medicare & Medicaid Services (CMS) to take a closer look at the benefits of telehealth for Medicaid beneficiaries.
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bsx-exalt-duodenoscope-hero-12-16.png

US FDA prodding clinical sites to transition to disposable duodenoscopes

April 6, 2022
By Mark McCarty
The FDA has updated its recommendations for the use of duodenoscopes, which have been at the center of ongoing concerns regarding sterility for several years. The agency is again recommending that U.S.-based facilities use duodenoscopes with disposable parts or fully disposable duodenoscopes, but facilities that want to comply with those recommendations will face a much higher cost of use, according to several sources of cost data.
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Regulatory actions for April 6, 2022

April 6, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Moleculight, Paige.
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Hand holding FDA blocks

GSK/Vir work on higher sotrovimab dose as FDA rescinds COVID-19 EUA

April 6, 2022
By Richard Staines
Glaxosmithkline plc and Vir Biotechnology Inc.’s sotrovimab has become the latest COVID-19 antibody to be pulled from the market in the U.S., after the FDA revoked its emergency use authorization (EUA) because of the rise of the omicron BA.2 subvariant.
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Australia to allow imports of overseas medicines to mitigate drug shortages

April 6, 2022
By Tamra Sami
Medicine shortages have been of particular concern during the COVID-19 pandemic, and Australia’s Therapeutic Goods Administration said it would seek to amend regulations to allow imports of overseas substitute drugs if the Australian drug has been discontinued and canceled from the Australian Register of Therapeutic Goods.
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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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