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system for esophageal protection during ablation
Patents

Patent filed for monitoring system to protect esophagus during cardiac ablation

Nov. 13, 2023
By Simon Kerton
Researchers from the University of Michigan have filed for patent protection of methods and systems to identify actual esophageal tissue changes and/or damage during cardiac ablation procedures.
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Regulatory actions for Nov. 13, 2023

Nov. 13, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Therabionic.
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Colorectal cancer 3D illustration

FDA approves Takeda’s fruquintinib in colorectal cancer

Nov. 13, 2023
By Tamra Sami
The U.S. FDA approved Takeda Pharmaceutical Co. Ltd.’s Fruzaqla (fruquintinib) nearly 20 days ahead of its Nov. 30 PDUFA date for adults with previously treated metastatic colorectal cancer. “Fruzaqla is the first targeted therapy approved in the U.S. for mCRC regardless of biomarker status or prior types of therapies in more than a decade,” Stefanie Granado, head of Takeda’s U.S. Oncology business unit, told BioWorld.
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Red blood cells

Takeda wins second FDA approval in two days with Adzynma for rare clotting disorder

Nov. 10, 2023
By Tamra Sami
With the U.S. FDA giving the green light to Takeda Pharmaceutical Co. Ltd.’s Adzynma for treating a rare blood clotting disorder caused by a deficiency in the ADAMTS13 enzyme, the company has won two approvals in two days after the FDA approved fruquintinib a day earlier.
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ACIP next as FDA clears Valneva chikungunya vaccine

Nov. 10, 2023
By Randy Osborne
With Valneva SE’s accelerated approval from the U.S. FDA for chikungunya vaccine Ixchiq, attention turned to the February 2024 meeting of the Advisory Committee on Immunization Practices (ACIP), which will vote on the product. A single-dose, live-attenuated vaccine, Ixchiq is designed to prevent disease caused by the virus in people 18 and older who are at increased risk of exposure to the bug.
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U.S. Capitol building, Washington D.C.

US Senate patent reform bill draws mixed reviews

Nov. 10, 2023
By Mark McCarty
The America Invents Act of 2011 was designed to provide a durable overhaul of the U.S. patent system, but the inter partes review (IPR) process has drawn fire from inventors as a patent-killing machine. The Senate is considering a new bill to address some of these concerns, but witnesses at a hearing this week were anything but united in their assessment of the status quo, making it difficult to forecast the fate of this latest effort at patent reform.
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Roche MS test secures FDA breakthrough device designation

Nov. 10, 2023
By Shani Alexander
The U.S. FDA granted Roche Holding AG breakthrough device designation for its Elecsys Neurofilament Light Chain test for multiple sclerosis. The Elecsys NfL test can aid in the detection of disease activity in adults, 18-55 years old, with relapsing-remitting multiple sclerosis or secondary progressive multiple sclerosis. It also provides critical information for managing the disease.
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Regulatory actions for Nov. 10, 2023

Nov. 10, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acon, Arup, 2curex.
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Regulatory actions for Nov. 9, 2023

Nov. 9, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Establishment Holdings, Owlet, Schemaview.
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Recor Medicaal Paradise renal denervation catheter

FDA greenlights Recor’s Paradise system for renal denervation

Nov. 9, 2023
By Shani Alexander
Recor Medical Inc. finally received U.S. FDA approval for its Paradise ultrasound renal denervation (RDN) system for the treatment of hypertension after more than ten years of research and clinical trials. Paradise is the first RDN system to reach the U.S. market, and its approval is good news for the technology after years of disappointment in the data from trials and concerns over the efficacy of RDN devices.
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