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Regulatory
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FDA approves Retevmo for advanced RET-driven lung and thyroid cancers

May 11, 2020
Digital illustration of U.S., coronavirus

FTC active in litigation over advertising, promotional claims during pandemic

May 8, 2020
By Mark McCarty
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
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
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
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
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
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.
Read More
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
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
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.
Read More

Remdesivir receives Japanese approval for severe COVID-19

May 8, 2020
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