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China and U.S. flags

​US FDA finalizes medical device destruction rule

May 30, 2024
By Mark McCarty
The problem of counterfeit devices has perplexed the U.S. FDA for some time, given that the agency had previously been forced to send the illicit products back to the originator, only to see the same devices reenter the U.S.
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Cancer

Full-Life Technologies’ PSMA-targeted radiopharmaceutical cleared for entry to clinic

May 30, 2024
Full-Life Technologies Ltd. has received IND clearance by the FDA, allowing it to conduct clinical trials of 225Ac-FL-020, its PSMA-targeted radiopharmaceutical for the treatment of metastatic castration-resistant prostate cancer.
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Colorized scanning electron microscope image of regulatory T cells and antigen-presenting cells.
Immuno-oncology

Georgiamune’s Treg inhibitor GIM-531 gains FDA clearance to enter clinic

May 30, 2024
Georgiamune Inc. has gained FDA clearance for its IND application for GIM-531, a first-in-class oral regulatory T cell (Treg) inhibitor that enables the restoration of a strong immune response against cancer.
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Judge's gavel with US flag

ACLA files suit against US FDA over lab-developed test final rule

May 29, 2024
By Mark McCarty
The American Clinical Laboratory Association has followed through on its promise to file suit against the U.S. FDA over the agency’s final rule for lab-developed tests. The lawsuit will be heard in the U.S. District Court for the Eastern District of Texas, which is also the venue for litigation against another federal government agency, the Federal Trade Commission, suggesting that litigants expect a favorable review of their case in this court.
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EU flags

EU’s Med4Cure garners €6.9B to support ‘major improvements’

May 29, 2024
By Nuala Moran
The EU has given the go ahead for a large-scale transnational project that will invest €6.9 billion (US$7.45 billion) to address unmet medical need and fill gaps across the pharmaceutical value chain.
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US NIH step closer to including price, as access, in licenses

May 29, 2024
By Mari Serebrov
Price is working its way indirectly into licensing agreements for U.S. NIH-funded inventions, be they drugs, biologics, vaccines or medical devices.
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Map of Europe, Medical Device Regulation (MDR) text

Team NB sees widening gap between MDR applications, certificates

May 29, 2024
By Mark McCarty
The European Association for Medical Devices of Notified Bodies has issued its survey of member NBs for 2023, which includes data that suggest a diminishing appetite for inspections under the Medical Device Single Audit Program. However, the more concerning metric is that the gap between applications for new or renewed medical devices and the number of completed applications continues to widen, a gap that stood at nearly 10,000 such applications at the end of calendar year 2023.
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Hand holding FDA blocks

Industry wary of limitations on FDA’s pre-submission program

May 29, 2024
By Mark McCarty
The U.S. FDA’s reissued draft guidance for pre-submission activity addresses the circumstances in which a manufacturer’s questions can be handled informally, but industry has a few misgivings about the draft. One of these is that a preformatted template proposed by the FDA would limit the number of topics that can be handled in an informal manner, which the Advanced Medical Technology Association said might drive more utilization of formal pre-submission programs, an outcome that would thwart the intent of these informal interactions.
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Camaps FX closed loop system

FDA approves first algorithm for use in pregnant women with type 1 diabetes

May 29, 2024
By Shani Alexander
The U.S FDA approved Camaps FX for use in pregnant women with type 1 diabetes. This first, hybrid, closed-loop app was developed by Camdiab Ltd., a spinout from Cambridge University, allows individuals aged two years and older with type 1 diabetes to manage their glucose levels.
Read More
Clinical research concept with medical icons on light bulb
Immuno-oncology

Anaveon’s ANV-600 cleared for clinical trials

May 29, 2024
Anaveon AG has received FDA approval of its IND application to conduct a phase I/II study of ANV-600.
Read More
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