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Regulatory
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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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WTO logo

Turkey disputes WTO findings, US 301 calls out the same bad actors

April 29, 2022
By Mari Serebrov
Not satisfied with the findings of a World Trade Organization (WTO) dispute panel, Turkey informed the WTO April 28 that it has initiated arbitration proceedings to review those findings, which involve an EU complaint about measures Turkey employs concerning the production, importation and marketing of prescription drugs.
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Regulatory actions for April 29, 2022

April 29, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Beigene, Cara, CNS, Janssen, Jasper, Moderna, Mycovia, Nevakar, SQZ, Timber, Vifor, Xbiotech.
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Camzyos bottle

BMS wins FDA approval for chronic HCM drug mavacamten

April 29, 2022
By Lee Landenberger and Richard Staines
Bristol Myers Squibb Co.’s audacious $13.1 billion 2020 takeover of Myokardia Inc. appears to have paid off with U.S. FDA approval of the drug at the heart of the deal, mavacamten. The medicine, a cardiac myosin inhibitor for treating adults with obstructive hypertrophic cardiomyopathy (HCM), will be marketed under the brand name Camzyos.
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