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BioWorld - Saturday, January 28, 2023
Home » Topics » Regulatory

Regulatory
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Digital illustration of U.S., coronavirus

FTC active in litigation over advertising, promotional claims during pandemic

May 8, 2020
By Mark McCarty
No Comments
The U.S. FDA’s enforcement regarding products related to the COVID-19 pandemic has picked up steam recently, but the U.S. Federal trade commission (FTC) is also involved in this enforcement arena. Leonard Gordon, a partner at Venable LLP’s New York office, told BioWorld that while the FTC and FDA missions seem to overlap, the FTC primarily targets unsupportable advertising claims rather than product labeling, a particularly relevant area in the COVID-19 pandemic.
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Australia map, flag

As Australia and New Zealand prepare to ease COVID-19 restrictions, New Zealand restricts POC tests

May 8, 2020
By Tamra Sami
No Comments
PERTH, Australia – As New Zealand and Australia prepare to open their economies, regulators in these two neighboring countries are taking very different approaches to regulating COVID-19 devices with New Zealand restricting point-of-care tests, while Australia imposes tougher postmarket activities.
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Regulatory front for May 8, 2020

May 8, 2020
No Comments
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: Bedfont Scientific, Philosys, Rutgers Clinical Genomics Laboratory, Spectrum Solutions, University of Kentucky.
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Regulatory actions for May 8, 2020

May 8, 2020
No Comments
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aidoc.
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Bridge Biotherapeutics receives MFDS approval for EGFR drug in lung cancer

May 8, 2020
By Gina Lee
No Comments
HONG KONG – South Korea’s Bridge Biotherapeutics Inc. wrapped up the week by announcing its awaited IND clearance for its epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, BBT-176, for non-small-cell lung cancer (NSCLC) from the country’s Ministry of Food and Drug Safety (MFDS) on May 7.
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Approved stamp

Canbridge wins China approval for breast cancer drug Nerlynx, nod for MPS drug could come next

May 8, 2020
By Elise Mak
No Comments
BEIJING – Beijing-headquartered Canbridge Pharmaceuticals Inc. is to add another source of income after Chinese regulators approved Nerlynx (neratinib) to be marketed for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy.
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Japanese shield and coronavirus

Japan advances fight against COVID-19 with four-day approval for remdesivir

May 8, 2020
By Alfred Romann and Gina Lee
No Comments
HONG KONG – Japan has become the first country in the world to approve Veklury (remdesivir), Gilead Sciences Inc.’s experimental drug, to treat COVID-19. The fast approval was based on U.S. data and that country’s emergency use of the drug to tackle the pandemic, although it is unclear whether the drug is safe or effective for treating COVID-19.
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Regulatory actions for May 8, 2020

May 8, 2020
No Comments
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amgen, Arch, Bridge, Cynata, Cytokinetics, Junshi, Pluristem, Redhill, Sesen, Takeda.
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Remdesivir receives Japanese approval for severe COVID-19

May 8, 2020
No Comments

Gilead’s remdesivir receives exceptional approval in Japan for COVID-19

May 7, 2020
By Peter Winter
No Comments
Just days after Foster City, Calif.-based Gilead Sciences Inc. gained emergency use authorization (EUA) from the FDA for antiviral Veklury (remdesivir) for the treatment of patients with SARS-CoV-2 infection, the virus that causes COVID-19, Japan invoked its own exceptional approval pathway to give the drug the green light to treat patients with severe COVID-19.
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