FDA warns Globus subsidiary HBT over ViaCell production facility issues

The FDA this week released a warning letter it sent to a Globus Medical (NYSE:GMED) subsidiary Human Biologics of Texas, which produces the company’s ViaCell allograft product, over issues it found during an inspection of the facility in April. The federal watchdog noted multiple infractions during the initial inspection, and also provided a response to corrective actions the company said it was taking in response to the earlier noted issues. In its in inspection, FDA investigators noted failures to document and investigate deviations in its production of the ViaCell product as well as trends of deviations away from the agency’s core current good tissue practice requirements. “For example, since the start of ViaCell processing in October 2016 through August 2017, you have had monthly sterility failure rates of [redacted] during seven of those months, with one month having a sterility failure rate of [redacted]. Your firm failed to conduct an investigation of all these sterility failures to determine the cause. You also failed to investigate additional sterility failures that occurred from October 2017 through February 2018. By neglecting to identify the cause of the sterility failures, you also failed to take appropriate corrective action(s) to prevent recurrence of the failures,” the FDA wrote in its letter. The agency also noted a failure to “validate and approve a process according to established procedures where the results of processing...
Source: Mass Device - Category: Medical Devices Authors: Tags: Food & Drug Administration (FDA) Regenerative Medicine Regulatory/Compliance Globus Medical Source Type: news

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Conclusion: Considering the high prevalence of UTI and antibiotic resistance rates in kidney transplant patients in our study, there is an urgent need for developing hospital based local antibiogram for appropriate management of UTI. Fosfomycin as an empirical therapy might be a useful choice for adequate coverage of potential pathogens at our centre. Further multi-centric studies on a larger sample size are recommended from India for formulating antibiotic policy. PMID: 32610862 [PubMed - in process]
Source: Journal of the Association of Physicians of India - Category: General Medicine Tags: J Assoc Physicians India Source Type: research
Globally, more than 1.5 million patients undergo bone graft surgeries annually, and the development of biomaterial scaffolds that mimic natural bone for bone grafting remains a tremendous challenge. In recent decades, due to the improved understanding of the mechanisms of bone remodeling and the rapid development of gene therapy, RNA (including messenger RNA (mRNA), microRNA (miRNA), and short interfering RNA (siRNA)) has attracted increased attention as a new tool for bone tissue engineering due to its unique nature and great potential to cure bone defects. Different types of RNA play roles via a variety of mechanisms in ...
Source: Theranostics - Category: Molecular Biology Authors: Tags: Review Source Type: research
Large bone reconstruction is a major clinical issue associated with several challenges, and autograft is the main method for reconstructing large defects of maxillofacial bone. However, postoperative osteoporosis of the bone graft, even with sufficient vascularization, remains a primary problem. Therefore, better understanding of the mechanisms and clinical translation of bone homeostasis is required. Neuronal innervation of the bone is an emerging research topic, especially with regards to the role of peripheral nerves in regulating bone homeostasis. Moreover, sensory and autonomic nerves regulate this process via differe...
Source: Theranostics - Category: Molecular Biology Authors: Tags: Review Source Type: research
Conclusion: We used publicly available datasets to create a gene signature of AR that identified AR irrespective of immunosuppression regimen or recipient age. This study highlights a novel model to screen and validate biomarkers across multiple treatment regimens.
Source: Theranostics - Category: Molecular Biology Authors: Tags: Research Paper Source Type: research
Conclusion: These findings suggest that Tubastatin A downregulates Th17 cell function and suppresses acute lung allograft rejection, at least partially, via the HIF-1α/ RORγt pathway.
Source: Theranostics - Category: Molecular Biology Authors: Tags: Research Paper Source Type: research
Conclusions: JP1 was developed as a novel peptide that indicated therapeutic roles on proliferation and metastasis of melanoma through the NEDD4L-SP1-Integrin αvβ3 signaling.
Source: Theranostics - Category: Molecular Biology Authors: Tags: Research Paper Source Type: research
This article describes cases of bone augmentation with a combination of PRP + β -TCP and PRF + β -TCP for treatment of the chronic periapical lesion. The cases were followed for six months and one year and healing was evaluated quantitatively using cone beam computed tomography.
Source: Nigerian Journal of Clinical Practice - Category: Rural Health Authors: Source Type: research
EFFECT OF SUN EXPOSURE DURATION ON CYCLOOXYGENASE-2 EXPRESSION IN THE CONJUNCTIVA. Acta Clin Croat. 2019 Dec;58(4):639-646 Authors: Reisz Majić P, Cerovski B, Majić P, Krković I, Barać J, Bradvica Štenc I Abstract Pterygium is a multifactorial proliferative pathologic change of bulbar conjunctiva. The purpose of this study was to determine the effect of the duration of exposure to solar radiation (expressed in years) on the incidence of positive cyclooxygenase-2 (COX-2) finding in conjunctival tissue in two groups of patients. Group 1 consisted of 68 patients with primary pterygium having un...
Source: Acta Clinica Croatica - Category: General Medicine Tags: Acta Clin Croat Source Type: research
Conclusion: Targeting CTLA-4 degradation provides a novel means to prevent transplant rejection and induce transplant tolerance.
Source: Theranostics - Category: Molecular Biology Authors: Tags: Research Paper Source Type: research
AbstractPurposeThe purpose of this study was to compare the clinical outcomes of ST4 with those of STGs with a minimum follow-up of 3  years. The hypothesis was that functional outcomes of the ST4 technique are at least as good as those of the STG technique.Study designCohort study. Level of evidence, 3MethodsEighty-seven consecutive patients underwent isolated ACL reconstruction, 50 with the ST4 and 37 with STG. At the femoral side for both groups, the system of the fixation of the graft used a cortical fixation support and at the tibial side the group STG used an interference screw and the ST4 group used a tape lock...
Source: European Journal of Orthopaedic Surgery and Traumatology - Category: Orthopaedics Source Type: research
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