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Home » Topics » Regulatory

Regulatory
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Biogen, Eisai win FDA clearance for AD therapy Leqembi

Jan. 10, 2023
By Randy Osborne
As expected, the U.S. FDA gave its go-ahead to lecanemab, an amyloid-beta binder for mild cognitive impairment caused by Alzheimer’s disease (AD) and mild AD from Biogen Inc. and Eisai Co. Ltd, which have assigned to the compound the brand name Leqembi.
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China grants emergency use authorization for Merck’s COVID-19 drug

Jan. 10, 2023
By Doris Yu
China’s NMPA has approved Merck & Co. Inc.’s COVID-19 treatment molnupiravir for emergency use to combat the increasing number of cases in the country.
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Shionogi expands reach of COVID-19 antiviral, Xocova, to Korea and China

Jan. 10, 2023
By Tamra Sami
After receiving approval in Japan for its orally administered COVID-19 antiviral, 3CL protease inhibitor Xocova (ensitrelvir/S-217622) in late November, Shionogi & Co. Ltd. is gearing up for approvals in South Korea and China.
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Regulatory actions for Jan. 10, 2023

Jan. 10, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Act Genomics, Arthrex, Bactiguard, Cellmyx, Inogen, Medalliance, Micronoma.
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Regulatory actions for Jan. 10, 2023

Jan. 10, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biogen, Biora, Cantex, Eisai, Hifibio, Ideaya, Immorna, Krystal, Neurelis, Otsuka, Phio, Revance, Santhera, Secura, SK, Tenaya.
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Datar gets FDA breakthrough device designation for brain tumor blood test

Jan. 9, 2023
By T.V. Padma
The U.S. FDA has granted Datar Cancer Genetics Inc. a breakthrough device designation for Trinetra-Glio, a blood test to help in the diagnosis of brain tumors.
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Judge's gavel with US flag

DOJ indicts defendants who face decades of jail time for genetic testing false claims

Jan. 9, 2023
By Mark McCarty
The U.S. Department of Justice (DOJ) reported an indictment of three men alleged to have filed more than $100 million in genetic testing false claims directly or indirectly with the Medicare program. Two of the three defendants face as many as 65 years of incarceration if convicted, a clear sign that federal government agencies in the U.S. are more intent than ever on cracking down on fraud and abuse of federal health programs.
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European Commission proposes new extension of MDR timelines with conditions

Jan. 9, 2023
By Mark McCarty
The European Commission (EC) has proposed to extend compliance deadlines under the Medical Device Regulation (MDR) to 2027 for high-risk devices and to 2028 for low- and moderate-risk devices, seemingly providing some critical breathing room for manufacturers and patients alike. However, the proposal requires that manufacturers have an application on file for their legacy device by May 2024, suggesting that manufacturers will still face a crippling backlog in obtaining contracts with notified bodies to process these applications.
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Zoom Stroke Solution

Imperative opens up radial access for stroke treatment with FDA clearance

Jan. 9, 2023
By Annette Boyle
Imperative Care Inc. received U.S. FDA 510(k) clearance for its Zoom Rdl radial access system for treatment of ischemic strokes. The device is designed to enhance radial access for removal of clots in patients with tortuous anatomy and other challenges to the femoral access typically used, providing more options for both patients and physicians.
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Blue tachometer

Though down, accelerated approvals not out in 2022

Jan. 9, 2023
By Mari Serebrov
In the wake of ongoing criticism over the U.S. FDA’s 2021 accelerated approval of Biogen Inc.’s Alzheimer’s drug, Aduhelm, the percentage of novel drugs receiving accelerated approval last year was the lowest it’s been since 2018.
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