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3D bioprinter printing cells onto an petri dish.
Product liability and medical devices​

POC 3D printing offers no liability protection for device makers

Aug. 27, 2024
By Mark McCarty
Additive manufacturing at the point-of-care (POC) might seem to open the world of medical device litigation to new theories of liability, but that isn’t likely in part because hospitals are wary of assuming the elevated legal risk associated with taking ownership of POC manufacturing activities.
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OP5_INSU_POD_PDM_NoADH_RIGHT_RGB.jpg

Insulet’s Omnipod 5 FDA cleared for type 2 diabetes patients

Aug. 27, 2024
By Holland Johnson
Insulet Corp.’s Omnipod 5 automated insulin delivery system has been cleared by the US FDA for the indication of type 2 diabetes, making it the first automated insulin delivery system cleared for both type 1 and type 2 diabetes management.
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Pemgarda

Invivyd PrEPs for COVID-19 with Pemgarda data; season ‘upon us’

Aug. 27, 2024
By Randy Osborne
About two months after Astrazeneca plc said its application for sipavibart (AZD-3152) had been accepted by the EMA for pre-exposure prophylaxis (PrEP) against COVID-19 in immunocompromised people, Invivyd Inc. unveiled positive 180-day exploratory efficacy data from the company’s ongoing Canopy phase III trial with Pemgarda (pemivibart) in the same indication – and made known less happy news from regulators on the other side of the pond.
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3D illustration of knee joint

FDA approves Vericel’s Maci for knee cartilage defects

Aug. 26, 2024
By Holland Johnson
Vericel Corp.’s Maci for repairing cartilage defects in the knee has been approved by the U.S. FDA via a supplemental biologics license application. Using a patient’s own cells cultured on a porcine collagen membrane, Maci Arthro is delivered arthroscopically and allows for repair of knee cartilage defects up to 4 cm2.
Read More
Eye with digital overlay
Product liability and medical devices

AI presents potential for new theories of medical product liability

Aug. 26, 2024
By Mark McCarty
Product liability is always a point of concern for manufacturers of medical devices and other U.S. FDA-regulated products, and the broad contours of product liability jurisprudence are well known by corporate counsel. However, artificial intelligence products are rapidly pressing their way into routine clinical use, representing a technological shift that may occasionally deviate from the existing rules of the road where product liability is concerned.
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Medicare puzzle

Medicare contractors withdraw policy for allograft rejection testing

Aug. 26, 2024
By Mark McCarty
The U.S. CMS said its Medicare administrative contractors withdrew a draft local coverage determination that would have restricted the use of surveillance testing for allograft rejection.
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Real fluorescence microscopic view of human neuroblastoma cells
Immuno-oncology

Invenra’s bispecific antibody awarded US orphan drug designation for neuroblastoma

Aug. 26, 2024
Invenra Inc.’s bispecific antibody, INV-724, developed for the treatment of neuroblastoma, has been awarded orphan drug and rare pediatric disease designations by the FDA.
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Stamp with EU flag

EU clears Regeneron’s Ordspono, Merck’s Winrevair, ARS’ Eurneffy

Aug. 26, 2024
By Nuala Moran
Five months after getting a complete response letter from the U.S. FDA, Regeneron Pharmaceuticals Inc. has landed conditional European marketing approval for odronextamab, a bispecific antibody for treating lymphoma. Now named Ordspono, the approval is for treating adult patients with relapsed or refractory follicular lymphoma or diffuse large B-cell lymphoma, after two or more lines of therapy. The European Commission also approved Merck & Co. Inc.’s Winrevair (sotatercept) for pulmonary arterial hypertension and ARS Pharmaceuticals Inc.'s Eurneffy (inhaled epinephrine) for anaphylaxis.
Read More
Flag of Australia, sky background

TGA wigs out over assistive tech in new regulatory consultation

Aug. 23, 2024
By Mark McCarty
TGA opened a consultation for regulation of assistive technologies, a key element of which is to make determinations about the regulatory status of some of these products. While the agency makes clear that some items that are currently unregulated may soon be subject to regulation, one of the more innocuous-seeming articles that may fall under regulation is the common and seemingly innocuous wig.
Read More
Dermatologic

Azitra gains IND clearance for ATR-04 for EGFR inhibitor-associated dermal toxicity

Aug. 23, 2024
Azitra Inc. has obtained IND clearance from the FDA for a first-in-human phase I/II study of ATR-04 for moderate to severe EGFR inhibitor-associated dermal toxicity. The study is expected to begin by year-end.
Read More
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