FDA approves Xolair ® (omalizumab) for adults with nasal polyps

             Basel, 01 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved the company ’s supplemental Biologics License Application (sBLA) for Xolair® (omalizumab) for the add-on maintenance treatment of nasal polyps in adult patients 18 years of age and older with inadequate response to nasal corticosteroids.1 Nasal polyps can lead to a loss of smell and nasal congestion, and frequently co-occur with other respiratory conditions, such as allergies and asthma. With this approval, Xolair is now the first biologic for the treatment of nasal polyps that targets and blocks immunoglobulin E (IgE), a key driver of inflammation.“With Xolair, we observed significantly reduced nasal polyps and congestion symptoms in adults who had nasal polyps in two pivotal Phase III studies,” said Joseph Han, M.D., Chief of the Division of Rhinology and the Division of Allergy at Eastern Virginia Medical School and study investigator o f the POLYP 1 and POLYP 2 trials. “Xolair provides a new option for treating these patients, who often have other respiratory and allergic conditions that may further worsen symptoms.” The FDA ’s approval is based on results from the Phase III POLYP 1 and POLYP 2 trials. Both trials showed that adult patients with nasal polyps who had an inadequate response to nasal corticosteroids and re...
Source: Roche Media News - Category: Pharmaceuticals Source Type: news

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Just went to a skills lab and they divided us into small groups. Before beginning each skills session, when asked what your primary specialty was, if the person teaching the skill was from an anesthesiology background, more times than not if you answered something other than anesthesia, the proctor would say something similar to "Well I guess you didn't get any training in this in residency". This included a session on suturing after procedures such as SCS or pumps. Not saying all those... Read more
Source: Student Doctor Network - Category: Universities & Medical Training Authors: Tags: Pain Medicine Source Type: forums
This study investigated the effects of 12 wk of postexercise kefir consumption in cancer survivors who have undergone chemotherapy and/or radiation therapy. Methods All participants were enrolled in a structured exercise training program and separated into kefir (KEF) or control (CON) treatment groups. KEF consumed 8 oz. of kefir after exercise sessions (3 d·wk−1) for 12 wk. Outcome measures included assessments for body size and composition, aerobic fitness and muscular strength, medical history, and psychological state at pre- and postintervention time points. Blood was collected and analyzed for C-re...
Source: Medicine and Science in Sports and Exercise - Category: Sports Medicine Tags: CLINICAL SCIENCES Source Type: research
Conclusions Exercise training combined with multinutrient supplementation had a limited effect on ameliorating the adverse musculoskeletal consequences of ADT, likely related to the modest intervention adherence.
Source: Medicine and Science in Sports and Exercise - Category: Sports Medicine Tags: CLINICAL SCIENCES Source Type: research
This study aimed to assess the associations between serious injury (≥3-month time loss) and level of specialization among high-level female soccer players and to compare the specialization and college commitment ages of female youth soccer players to Division I college and professional soccer athletes. Methods Youth, college, and professional female soccer players in the United States playing in the top league at each level were recruited to complete an anonymous online survey. The survey collected information about player demographics, soccer specialization and training patterns, history of serious injuries from...
Source: Medicine and Science in Sports and Exercise - Category: Sports Medicine Tags: EPIDEMIOLOGY Source Type: research
Conclusion These findings demonstrate that T2D and HTN attenuate tolerance to uncompensable heat stress (32°C WBGT); however, these chronic diseases do not significantly impact thermal and cardiovascular strain, or the validity of ACIGH recommendations during moderate-intensity work.
Source: Medicine and Science in Sports and Exercise - Category: Sports Medicine Tags: APPLIED SCIENCES Source Type: research
In conclusion, the vast majority of the GIM samples (98%) lack the aneuploidy that is characteristic of gastric dysplasia or cancer. This indicates that aneuploidy usually occurs after the development of gastric dysplasia rather than at the stage of GIM. The finding also suggests that the presence of GIM alone may not be sufficient to suggest an increased risk for GC and that the inclusion of other high-risk features (ie, extensive GIM, dysplasia, racial minorities, and/or family history of GC in a first-degree relative) and/or aneuploidy ought to play a role in the selection of GIM patients who may warrant endoscopic surv...
Source: The American Journal of Surgical Pathology - Category: Pathology Tags: Original Articles Source Type: research
We present a relatively large retrospective cohort of urinary LCNEC, 20 from the urinary bladder, and 2 from the ureter, from a single institution. The patients included 16 men and 6 women with a median age of 74.5 years. Most LCNEC presented at an advanced stage with tumors invading the muscularis propria and beyond (21/22). Eight cases were pure LCNEC, while 14 cases were mixed with other histologic types, including conventional urothelial carcinoma (n=9), carcinoma in situ (n=7), small cell carcinoma (n=6), and urothelial carcinoma with glandular (n=3) features. Most LCNEC expressed neuroendocrine markers synaptophysin ...
Source: The American Journal of Surgical Pathology - Category: Pathology Tags: Original Articles Source Type: research
We examined 27 LELCC cases through next-generation sequencing using a panel of genes commonly mutated in primary liver cancers. Alterations in BAP1, ARID1A, ARID2, and PBRM1 were detected through immunohistochemistry. Fluorescence in situ hybridization was performed to analyze FGFR2 fusions and CCND1 amplification. LELCC is histologically classified as predominantly undifferentiated or glandular. Epstein-Barr virus–encoded small RNA (EBER) expression was found in 16 LELCCs. Approximately 50% of LELCCs expressed programmed death-ligand 1 strongly. Notably, recurrent pTERT and TP53 mutations were detected in 9 (38%) an...
Source: The American Journal of Surgical Pathology - Category: Pathology Tags: Original Articles Source Type: research
Venous invasion (VI) is a powerful prognostic factor in colorectal cancer (CRC) that is widely underreported. The ability of elastin stains to improve VI detection is now recognized in several international CRC pathology protocols. However, concerns related to the cost and time required to perform and evaluate these stains in addition to routine hematoxylin and eosin (H&E) stains remains a barrier to their wider use. We therefore sought to determine whether an elastin trichrome (ET) stain could be used as a “stand-alone” stain in CRC resections, by comparing the sensitivity, accuracy, and reproducibility of det...
Source: The American Journal of Surgical Pathology - Category: Pathology Tags: Original Articles Source Type: research
Inflammatory pseudotumor is a term used to designate inflammation-rich tumefactive lesions. Following the exclusion of specific entities such as IgG4-related disease and other neoplastic entities previously included in this entity, the majority of hepatic pseudotumors show a prominent fibrohistiocytic inflammatory reaction and have been previously categorized as fibrohistiocytic variant of hepatic pseudotumor (FHVHPT). The goal of this study was to examine the clinical, radiologic, histologic, and etiologic aspects of this entity. After excluding neoplastic diseases, we identified 30 patients with FHVHPT from 3 institution...
Source: The American Journal of Surgical Pathology - Category: Pathology Tags: Original Articles Source Type: research
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