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Regulatory
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Product recall concept image

Philips pulls Tack device due to problems with deployment

March 4, 2025
By Mark McCarty
Royal Phillips NV opted to withdraw the Tack endovascular repair device only six years after the U.S. FDA’s approved it. Tack is designed to repair vascular dissection caused by angioplasty. The associated recall lists 20 injuries and no fatalities, but the device design might be a culprit in forcing the withdrawal of the Tack.
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Illustration of tumor
Immuno-oncology

Fapon’s immunocytokine FP-008 gains IND clearance for solid tumors

March 4, 2025
Guangdong Fapon Biopharma Inc. has obtained IND clearance from the FDA for FP-008, its first-in-class immunocytokine for patients with solid tumors refractory to anti-PD-1 therapy.
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Researcher looking through a microscope

NIH changes set industry up for workforce, ideas drought

March 3, 2025
By Anette Breindl
On March 1, 2025, former NIH director Francis Collins’ announced that he had fully resigned from the NIH, where he continued to lead a laboratory after his resignation as director. Collins gave no reason for his resignation, but it comes just before this week’s confirmation hearings for Jay Bhattacharya, who is U.S. President Donald Trump’s nominee to lead the NIH and who Collins called a “fringe epidemiologist” during the COVID pandemic. It is a bitter irony that when Collins resigned as NIH director in 2021, then-President Joe Biden said that “countless researchers will aspire to follow in his footsteps.”
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Regulatory icons

US PTO peels back 2022 memo on discretionary denials of IPRs

March 3, 2025
By Mark McCarty
The U.S. Patent and Trademark Office has reversed a 2022 agency memorandum on discretionary denials of patent procedures, such as inter partes reviews.
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Leqembi gets another thumbs-up amid CHMP February recommendations

Feb. 28, 2025
By Nuala Moran
The EMA’s Committee for Medicinal products for Human Use (CHMP) is standing by its opinion on Leqembi (lecanemab) after the European .mission pushed back against a recommendation in November 2024 that the Alzheimer’s disease drug be approved
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Google Pixel Watch 3 Loss-of-pulse

FDA clears loss-of-pulse detection on Google Pixel Watch 3

Feb. 28, 2025
By Annette Boyle
The Apple Watch may be able to alert wearers to heart palpitations, but Google LLC’s Pixel Watch 3 can now detect when a user’s heart stops – and call emergency services. The pulse detection featured received clearance from the U.S. FDA on Feb. 26 and Google plans to make it available on its Pixel Watch 3 starting in March. Pulse detection is already available for watches sold in the U.K. and EU.
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Royal Philips NV Radiology Operations Command Center

Philips lands EU MDR for radiology remote scanning

Feb. 28, 2025
By Shani Alexander
Royal Philips NV recently secured EU MDR certification for the remote scanning capabilities on its Radiology Operations Command Center Console. The solution allows radiologists to remotely assist technologists in real-time by controlling scans to acquire images needed for improved diagnostic confidence and patient outcomes.
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Tug-of-war illustration

Novelty of PCCP filings a source of drag for FDA, industry

Feb. 28, 2025
By Mark McCarty
Nick Decker, directory of global regulatory policy for Roch Holding AG’s Roche Diagnostics division, said the FDA is moving carefully into the PCCP space, and industry, too, is taking a measured approach in adopting the PCCP concept.
Read More
Illustration of tumor
Immuno-oncology

Fapon’s immunocytokine FP-008 gains IND clearance for solid tumors

Feb. 28, 2025
Guangdong Fapon Biopharma Inc. has obtained IND clearance from the FDA for FP-008, its first-in-class immunocytokine for patients with solid tumors refractory to anti-PD-1 therapy.
Read More
Ryoncil

Mesoblast prices pediatric stem cell treatment at $1.55 million

Feb. 27, 2025
By Tamra Sami
Regenerative medicine company Mesoblast Ltd. is preparing to launch its allogeneic bone marrow-derived mesenchymal stromal cell (MSC) therapy, Ryoncil, (remestemcel-L), in March in the U.S. and has priced the treatment at roughly $1.55 million for a full course.
Read More
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