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Home » Topics » Regulatory

Regulatory
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Lifecradle Heart Preservation Transport System

Breakthrough device designation granted Lifecradle organ preservation system

May 2, 2022
By David Godkin
Bridge to Life Ltd. has won FDA breakthrough device designation for its Lifecradle Heart Preservation Transport System enabling clinicians to affordably implement hypothermic oxygenated perfusion of heart grafts during organ transport. Lifecradle employs a “plug-and-play” design to differentiate it from historic static cold storage but also from “normothermic” preservation which provides oxygen delivery at near physiologic temperatures.
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FDA approved icons and medical professional

Orphalan wins US FDA approval for Wilson’s disease drug Cuvrior

May 2, 2022
By Nuala Moran
Orphalan SA is laying the ground for a 2023 U.S. launch of Cuvrior for the treatment of Wilson’s disease, following FDA approval of the copper chelating drug. Cuvrior (trientine tetrahydrochloride) is a new salt of trientine that was designed to have superior properties to Syprine (trientine hydrochloride) from Bausch Health Companies Inc. and Cufence from Univar Solutions BV, which are approved as second-line treatments for the rare inherited copper transport disorder, in the U.S. and EU respectively.
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DNA

US FDA advises on ctDNA as a biomarker for certain early stage cancers

May 2, 2022
By Mari Serebrov
The latest in a spate of draft and final guidances released recently by the U.S. FDA could help sponsors developing drugs to treat early stage solid tumor malignancies. 
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Regulatory actions for May 2, 2022

May 2, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Exsomed, Rhinostics, Silk Road Medical.
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CRLs make week's start rough start for four companies

May 2, 2022
By Lee Landenberger
A quartet of companies on May 2 announced three complete response letters (CRLs) that left them scrambling to get back on the path to approval. Hutchmed Ltd.'s surufatinib met with word from the U.S. FDA that two positive phase III studies in China and a bridging study in the U.S. would not support approval of the drug for pancreatic and extra-pancreatic neuroendocrine tumors. A multi-regional clinical trial in the U.S. is needed, the regulator said, brushing aside China-only studies when seeking a U.S. approval.
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Regulatory actions for May 2, 2022

May 2, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bristol Myers Squibb, Finch, Gilead, Merck, Moderna, Pfizer.
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In boon to sector, surgical robots receive NMPA approvals

April 29, 2022
By Zhang Mengying
The NMPA approved two different surgical robots for marketing, a step forward in growth of a sector that remains underdeveloped in China. One of the robots approved for marketing by the NMPA is from Yuanhua Orthopedic Robotic Ltd. and the other is Suzhou Microport Orthobot Co. Ltd. Both robots are used for total knee arthroplasty (TKA), removing damaged cartilage and bones from the surface of the knee joint and replacing them with artificial implants.
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Gloved hands holding a heart

Transmedics expands FDA PMA approval for heart transplant system

April 29, 2022
By Catherine Longworth
The U.S. FDA has granted premarket approval for Transmedics Group Inc.’s OCS heart system for use with organs from donors after circulatory death (DCD). The approval expands on a prior FDA approval of the device for use with organs from donors after brain death in September 2021. Andover, Mass.-based Transmedics said its system can now be used for ex vivo reanimation, functional monitoring, and beating-heart preservation of donation-after-circulatory-death hearts.
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Regulatory actions for April 29, 2022

April 29, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Clearpoint Neuro, Venus Concept.
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Australia to begin routine GCP inspections for clinical trial sites

April 29, 2022
By Tamra Sami
Australia’s Therapeutic Goods Administration will begin conducting routine risk-based good clinical practices (GCP) inspections for clinical trials of drugs and biologics. The agency outlined in final guidance how it would prioritize inspections, what the process would look like and how it would report and follow up on inspections.
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