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FDA leery of using PCCP mechanism for special 510(k) filings

Sep. 17, 2024
By Mark McCarty
The U.S. FDA’s draft guidance for predetermined change control protocols (PCCPs) is out for comment, but a recent agency webinar highlighted some areas of ambiguity.
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Zimmer to phase out CPT device, but FDA wary of existing inventory

Sep. 17, 2024
By Mark McCarty
The U.S. FDA reported Sept. 17 that the Zimmer Biomet Holdings Inc. CPT hip system is associated with an increased risk of thighbone fracture, a problem Zimmer acknowledged with a July 2, 2024, class II recall.
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Neurology/psychiatric

Somite’s SMT-M01 awarded US orphan drug designation for Duchenne muscular dystrophy

Sep. 17, 2024
Somite Therapeutics Inc.’s lead program, SMT-M01, has been awarded orphan drug and rare pediatric disease designations by the FDA for the treatment of Duchenne muscular dystrophy (DMD). The program leverages the company’s proprietary Alphastem artificial intelligence (AI) platform to develop a novel cell replacement therapy for DMD.
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Senators send stern message to US FDA on animal testing

Sep. 16, 2024
By Mari Serebrov
While it’s called the FDA Modernization Act (FDAMA) 3.0, the short bipartisan bill introduced in the U.S. Senate Sept. 15 is basically a message to the FDA: “The move away from animal testing in FDAMA 2.0 wasn’t a congressional suggestion. It’s a mandate, so get it done.”
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US FDA: Context matters in cancer trials

Sep. 16, 2024
By Mari Serebrov
Putting in writing what it’s been saying at advisory committee meetings, the U.S. FDA is issuing a draft guidance on multiregional clinical trials for cancer drugs that underscores the need for applicability to the U.S. population and medical practices.
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FDA Approved stamp

Genentech’s new multiple sclerosis treatment reduces admin time

Sep. 16, 2024
By Lee Landenberger
Genentech’s newly approved multiple sclerosis (MS) injection takes about 10 minutes to administer, dramatically reducing the four to six hours required by its intravenous predecessor. The U.S. FDA approved the humanized monoclonal antibody Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) for relapsing MS and primary progressive MS on Sept. 13.
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Woman itching wrist

Lilly’s Ebglyss enters US atopic dermatitis market with FDA nod

Sep. 16, 2024
By Jennifer Boggs
Eli Lilly and Co.’s Ebglyss (lebrikizumab) becomes the latest U.S. entrant in the increasingly competitive atopic dermatitis space, following FDA approval of the IL-13-targeting antibody, which will now go up against other biologics such as established blockbuster Dupixent (dupilumab, Regeneron Pharmaceuticals Inc.), as well as more recently approved Adbry (tralokinumab, Leo Pharma Inc.).
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Science and medicine icons with head made of computer code

FDA to convene advisory meeting on generative AI-enabled devices

Sep. 16, 2024
By Mark McCarty
The Nov. 20-21 meeting of the digital health advisory committee will discuss the use of generative artificial intelligence algorithms in medical devices with a focus on the total product life cycle – a theme that suggests a concern on the agency’s part regarding the reliability of these algorithms’ output.
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exact-sciences-cologuard-test-kit-10-31.png

Exact Sciences presents data to bolster colon cancer test

Sep. 16, 2024
By Holland Johnson
Exact Sciences Corp. reported performance data for its blood-based colorectal cancer screening test that showed sensitivities of 88.3% for CRC and 31.2% for advanced precancerous lesions at specificity of 90.1% for negative samples confirmed by colonoscopy.
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WHO headquarters, Geneva

WHO leaning in on regulatory harmonization for devices

Sep. 16, 2024
By Mark McCarty
Hiiti Sillo, director of the WHO’s office for regulation and safety, told an audience at this year’s IMDRF meeting in Seattle that WHO is putting the finishing touches on a streamlined product application dossier process, one of several work products that should be ready for publication sometime in 2025.
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