20 research outputs found
Increasing Patient Engagement in Pharmacovigilance Through Online Community Outreach and Mobile Reporting Applications: An Analysis of Adverse Event Reporting for the Essure Device in the US
Considering Other Consumers: Fisheries, Predators, and Atlantic Herring in the Gulf of Maine
After decades of overexploitation and severe depletion, Atlantic herring stocks in waters of the northeastern United States have recovered. Fishery managers now consider the herring resource to be underexploited. Nevertheless, some fishery managers and sustainable fishery advocates in New England have expressed concern that the fishery management plan may not adequately consider the importance of herring as prey for marine mammals, seabirds, and piscivorous fish. Several studies suggest that consumption by these predators is significant, yet trophic interactions are not explicitly considered in stock assessment models. Instead, as in most fisheries stock assessments, predation is subsumed within the natural mortality rate, and no empirical estimates of herring consumption are used in the models. The goal of the present study was to assess the consumption of herring by marine mammals and to compare this level of consumption with estimates of natural mortality derived from herring stock assessment models. Using the most recent estimates of abundance and the best available data on diet, we estimated total annual consumption of herring by eight marine mammal species in the Gulf of Maine. Our results indicate that marine mammals consume 93,802-189,898 metric tons (mt; 1 metric ton = 1000 kg) of herring annually. In addition, piscivorous fish and seabirds are important predators of herring. We estimate that the consumption of herring by these upper trophic level predators may have exceeded the estimate of natural mortality used in stock assessment models by more than fourfold in 1991. We suggest that fisheries management must move beyond a single-species approach to one that includes formal consideration of trophic relationships
Phase 1 study of REGN1400 (anti-ErbB3) combined with erlotinib or cetuximab in patients (pts) with advanced non-small cell lung cancer (NSCLC), colorectal cancer (CRC), or head and neck cancer (SCCHN).
First-in-human study assessing safety and tolerability of REGN1979, a novel CD20xCD3 bispecific antibody, in patients with CD20+ B-cell malignancies previously treated with anti-CD20 therapy.
Phase 1 first-in-human (FIH) study of nesvacumab (REGN910) a fully human and selective angiopoietin-2 (Ang2) monoclonal antibody (MAb): Results from hepatocellular carcinoma (HCC) cohort.
Randomized Phase II Study of Erlotinib in Combination With Placebo or R1507, a Monoclonal Antibody to Insulin-Like Growth Factor-1 Receptor, for Advanced-Stage Non–Small-Cell Lung Cancer
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Early clinical experience of bacteriophage therapy in 3 lung transplant recipients.
Bacteriophage therapy (BT) uses bacteriophages to treat pathogenic bacteria and is an emerging strategy against multidrug-resistant (MDR) infections. Experience in solid organ transplant is limited. We describe BT in 3 lung transplant recipients (LTR) with life-threatening MDR infections caused by Pseudomonas aeruginosa (n = 2) and Burkholderia dolosa (n = 1). For each patient, lytic bacteriophages were selected against their bacterial isolates. BT was administered for variable durations under emergency Investigational New Drug applications and with patient informed consent. Safety was assessed using clinical/laboratory parameters and observed clinical improvements described, as appropriate. All patients received concurrent antibiotics. Two ventilator-dependent LTR with large airway complications and refractory MDR P. aeruginosa pneumonia received BT. Both responded clinically and were discharged from the hospital off ventilator support. A third patient had recurrent B. dolosa infection following transplant. Following BT initiation, consolidative opacities improved and ventilator weaning was begun. However, infection relapsed on BT and the patient died. No BT-related adverse events were identified in the 3 cases. BT was well tolerated and associated with clinical improvement in LTRs with MDR bacterial infection not responsive to antibiotics alone. BT may be a viable adjunct to antibiotics for patients with MDR infections
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The 2020 BMT CTN Myeloma Intergroup Workshop on Immune Profiling and Minimal Residual Disease Testing in Multiple Myeloma
The fifth annual Blood and Marrow Transplant Clinical Trials Network Myeloma Intergroup Workshop on Immune Profiling and Minimal Residual Disease Testing in Multiple Myeloma was conducted as one of the American Society of Hematology Annual Meeting Scientific Workshops on Thursday December 3, 2020. This workshop focused on four main topics: (1) integrating minimal residual disease into clinical trial design and practice; (2) the molecular and immunobiology of disease evolution and progression in myeloma; (3) adaptation of next-generation sequencing, next-generation flow cytometry, and cytometry by time of flight techniques; and (4) chimeric antigen receptor T-cell and other cellular therapies for myeloma. In this report, we provide a summary of the workshop presentations and discuss future directions in the field