FDA rejects Novartis ’ Advair generic, leaving GSK without rival

GlaxoSmithKline (NYSE:GSK) was granted a temporary win today after Novartis‘ (NYSE:NVS) Sandoz unit reported that the FDA rejected its application for a generic version of the company’s blockbuster lung treatment, Advair. The regulatory agency reportedly told Novartis that it needs to submit additional clinical data before the FDA can make its final decision. Get the full story at our sister site, Drug Delivery Business News. The post FDA rejects Novartis’ Advair generic, leaving GSK without rival appeared first on MassDevice.
Source: Mass Device - Category: Medical Devices Authors: Tags: Drug-Device Combinations Food & Drug Administration (FDA) Pharmaceuticals Regulatory/Compliance Respiratory Wall Street Beat GlaxoSmithKline plc Novartis sandoz Source Type: news

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Source: The Guttmacher Institute - Category: International Medicine & Public Health Authors: Source Type: news
Supriya G. Mohile, M.D., M.S., an oncologist at the Wilmot Cancer Institute and trailblazer in the growing field of geriatric oncology, has been named the 2018 winner of the B.J. Kennedy Award by the American Society of Clinical Oncology (ASCO). She will deliver the B.J. Kennedy Lecture on June 4 at ASCO ’s annual meeting in Chicago.
Source: University of Rochester Medical Center Press Releases - Category: Universities & Medical Training Authors: Source Type: news
CONCLUSIONS: Further studies using biomarker-underpinned diagnoses are warranted to shed more light on the potential diagnostic utility of BACE1 activity as AD biomarker candidate in MCI. PMID: 29788013 [PubMed - as supplied by publisher]
Source: Dementia and Geriatric Cognitive Disorders - Category: Psychiatry Tags: Dement Geriatr Cogn Disord Source Type: research
Antioxidants&Redox Signaling,Volume 28, Issue 18, Page 1746-1746, June 20, 2018.
Source: Antioxidants and Redox Signaling - Category: Research Source Type: research
Lung cancer has long been associated mostly with men. But a new study finds a disturbing trend among women, even among those who do not smoke. Tara Narula reports.
Source: Health News: CBSNews.com - Category: Consumer Health News Source Type: news
CONCLUSIONS: Psychiatry residents show signs of high emotional exhaustion, which is associated with burnout. Results demonstrate a strong positive correlation between EHR use and resident burnout. Time spent on EHR use may be an area of importance for psychiatry program directors and other psychiatric educators to consider when seeking to minimize burnout and promote wellness. PMID: 29785625 [PubMed - as supplied by publisher]
Source: The Journal of American Association of Directors of Psychiatric Residency Training - Category: Psychiatry Tags: Acad Psychiatry Source Type: research
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Source: Medscape Medical News Headlines - Category: Consumer Health News Tags: Pediatrics News Alert Source Type: news
No abstract available
Source: Health Physics - Category: Radiology Tags: Introduction Source Type: research
In this study, global metabolomic changes were analyzed using ultraperformance liquid chromatography quadrupole time-of-flight mass spectrometry. The pilot study using 16 nonhuman primates (8 nonhuman primates each in gamma-tocotrienol- and vehicle-treated groups), with samples obtained from gamma-tocotrienol-treated and irradiated nonhuman primates, demonstrates several metabolites that are altered after irradiation, including compounds involved in fatty acid beta-oxidation, purine catabolism, and amino acid metabolism. The machine-learning algorithm, Random Forest, separated control, irradiated gamma-tocotrienol‐treate...
Source: Health Physics - Category: Radiology Tags: Papers Source Type: research
This study investigated skin fixation and efficacy of decontamination products for these actinide forms using viable pig skin in the Franz cell diffusion system. Commonly used or recommended decontamination products such as water, cleansing gel, diethylenetriamine pentaacetic acid, or octadentate hydroxypyridinone compound 3,4,3‐LI(1,2‐HOPO), as well as diethylenetriamine pentaacetic acid hydrogel formulations, were tested after a 2‐h contact time with the contaminant. Analysis of skin samples demonstrated that more plutonium nitrate is bound to skin as compared to plutonium-tributyl phosphate, and fixation of americ...
Source: Health Physics - Category: Radiology Tags: Papers Source Type: research
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