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Illustration of antibodies targeting cancer cell
Immuno-oncology

China’s NMPA clears Simcere Zaiming’s FGFR2b-targeting ADC to enter clinic

April 15, 2025
Simcere Zaiming Pharmaceutical Co. Ltd. has received clinical trial approval from China’s National Medical Products Administration (NMPA) for the company’s antibody-drug conjugate (ADC), SIM-0686, for FGFR2b-positive, locally advanced or metastatic solid tumors.
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Edwards Lifesciences Sapien M3

Edwards lands first CE mark for transfemoral mitral valve replacement

April 14, 2025
By Annette Boyle
Edwards Lifesciences Corp.’s Sapien M3 secured CE mark for its Sapien M3 mitral valve replacement system for transfemoral treatment of patients with mitral valve disease who are ineligible for surgery or transcatheter edge-to-edge repair. Sapien M3 is indicated for individuals with symptomatic moderate-to-severe or severe mitral valve regurgitation.
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Illustration of TAVR device

CMS disinclined to reassign TAVR procedures to higher-paying DRG​

April 14, 2025
By Mark McCarty
The U.S. Medicare draft inpatient rule for fiscal 2026 discusses a number of coding proposals, although the agency seems disinclined to go along with a proposal to increase payment rates for TAVR devices by switching the procedures to a different diagnostic-related group.
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Medicare puzzle

Gore petitions CMS to reassign DRG for thoracic branch devices

April 14, 2025
By Mark McCarty
The new technology add-on payment for the TAG thoracic branch endoprosthesis is likely coming to an end, but the device’s manufacturer, Gore Medical Inc., petitioned CMS to reassign the procedure to a new diagnostic-related group that would more accurately reflect the costs of the related procedure.
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New UK law aims for ‘faster, fairer and more inclusive’ clinical trials

April 14, 2025
By Nuala Moran
As new clinical trials regulations were signed into law in the U.K., an analysis of 4,616 submissions to conduct studies has highlighted what is required for the updated law to translate into a more efficient, streamlined and adaptable regulatory framework.
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Lab mouse
Drug design, drug delivery & technologies

FDA wants a shift away from animal testing

April 14, 2025
By Lee Landenberger
In a roadmap to change animal testing requirements for INDs, the U.S. FDA said its new approach will improve drug safety, hasten the evaluation process, and lower costs for companies and patients. It’s another step in a process of changing rules put in place decades ago.
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Heart illustration
Cardiovascular

CSPC’s SYH-2046 gains clinical trial clearance in China for heart failure

April 14, 2025
CSPC Pharmaceutical Group Ltd. has obtained clinical trial approval from China’s National Medical Products Administration (NMPA) for SYH-2046 for heart failure after acute myocardial infarction.
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Dexcom G7 CGM

FDA clears Dexcom G7 15 Day

April 11, 2025
By Annette Boyle
The battle to claim the continuous glucose monitor with the longest wear time continues with Dexcom Inc.’s G7 15 Day continuous glucose monitor gaining U.S. FDA clearance on April 10 for adults with diabetes. The company said it now takes the lead with the 15-day duration, but Abbott Laboratories also offers 15 days of useful life for its Freestyle Libre 3 plus.
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David Luria Ziv Menshes

Cardiovia Viaone epicardial access system secures US FDA clearance

April 11, 2025
By Shani Alexander
Cardiovia Ltd.' Viaone epicardial access system received U.S. FDA clearance for treating cardiac arrhythmias. The device provides clinicians with a safe and minimally invasive technology to reach the heart’s outer surface, known as the pericardial space, without the need for a sharp needle, which can cause perforation.
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Data privacy illustration

States active on privacy as Congress convenes work group

April 11, 2025
By Mark McCarty
The thicket of state-based privacy regulation in the U.S. grows thicker by the day, but Congress seems poised to step in with a bipartisan group that may propose legislation that preempts privacy law.
Read More
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