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Regulatory
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Medicare puzzle

US doc fee schedule for 2024 hits radiology, oncology care, but Congress eyeing override

Nov. 6, 2023
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services has followed through on an earlier threat to reduce payments for various sorts of radiology services in the physician fee schedule, including those invoked during episodes of cancer care, but Congress may yet intervene.
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Regulatory actions for Nov. 6, 2023

Nov. 6, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Smileyscope.
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Breast cancer cells.
Immuno-oncology

FDA clears Briacell’s personalized cellular immunotherapy to enter clinic

Nov. 6, 2023
Briacell Therapeutics Corp. has received IND clearance from the FDA to begin clinical studies with Bria-OTS, the first generation of the company’s personalized off-the-shelf cellular immunotherapy for breast cancer.
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Antibodies attacking cancer cell
Immuno-oncology

CSPC Pharmaceutical’s SYS-6011 cleared to enter clinic in China for solid tumors

Nov. 6, 2023
CSPC Pharmaceutical Group Ltd.’s SYS-6011 has been cleared by China’s National Medical Products Administration (NMPA) to enter clinical trials in China for solid tumors.
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Laptop displaying FDA logo
FDLI Advertising and Promotion Conference

US DOJ: company history, potential for harm drive criminal charges for marketing

Nov. 3, 2023
By Mark McCarty
The U.S. Department of Justice (DOJ) has a unique role in enforcement of medical product communication even though the department shares oversight of medical product promotions with the FDA and the Federal Trade Commission (FTC).
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Companies agree to work with governments to test AI models

Nov. 3, 2023
By Shani Alexander
Companies developing Artificial intelligence (AI)-enabled solutions have agreed to work with governments to test models both pre- and post-deployment, in a bid to manage the risks around security, safety and societal harms. The landmark agreement was reached at the first AI Safety Summit, held at Bletchley Park, in the U.K.
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U.S. Capitol building
FDLI Advertising and Promotion Conference

US data privacy environment a tangled web for med-tech companies

Nov. 3, 2023
By Mark McCarty
Privacy considerations have been front and center for U.S. federal government agencies for more than two decades, but several states have jumped into the privacy arena with their own legislative imperatives. While companies in the medical device industry would like to see a less imposing thicket of related enforcement requirements, Nancy Perkins of Arnold & Porter LLP said there is little prospect that Congress will relieve the predicament with anything resembles preemptive legislation.
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Regulatory actions for Nov. 3, 2023

Nov. 3, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Empatica, Polaris.
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Immuno-oncology

Prokarium’s ZH-9 cleared to enter clinic in US for bladder cancer

Nov. 3, 2023
Prokarium Ltd. has obtained FDA clearance of its IND application for ZH-9 for patients with non-muscle invasive bladder cancer.
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Antibody-drug conjugate
Immuno-oncology

Angiex cleared to begin phase I study of TM4SF1-directed ADC

Nov. 3, 2023
Angiex Inc. has received FDA clearance of its IND application for AGX-101, a novel TM4SF1-directed antibody-drug conjugate (ADC) being developed for the treatment of solid cancers.
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