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BioWorld - Monday, July 7, 2025
Home » Topics » Regulatory

Regulatory
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GSK trade secret theft a family affair

May 3, 2022
By Mari Serebrov
In an ongoing sibling saga of biopharma trade secret theft, Gongda Xue, a Swiss resident and Chinese citizen, has been convicted, following a U.S. trial, of charges related to a conspiracy to steal trade secrets from Glaxosmithkline plc over a six-year period beginning in 2010, the U.S. Attorney’s Office for the Eastern District of Pennsylvania reported May 2.
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Medicare puzzle

US CMS told to stay in its lane on coverage decisions

May 3, 2022
By Mari Serebrov
The U.S. Centers for Medicare & Medicaid Services’ (CMS) decision last month restricting coverage of a class of Alzheimer’s drugs to clinical trials meeting the agency’s standards still isn’t sitting well with some lawmakers.
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Regulatory actions for May 3, 2022

May 3, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biosensors International, Isono Health, Mirvie, Spinex, Strados, Suneva Medical, X-Therma.
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Regulatory actions for May 3, 2022

May 3, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Axsome, Biogen, Coherus, Horizon, Hutchmed, Ideaya, Junshi, Moderna, Myovant, Novavax, Regeneron, Sage, Supernus, Vaxxinity, Vertex, Vitti.
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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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