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https://www.readbyqxmd.com/read/28230450/characteristics-and-medication-use-of-psoriasis-patients-who-may-or-may-not-qualify-for-randomized-controlled-trials
#1
William Malatestinic, Beth Nordstrom, Jashin J Wu, Orin Goldblum, Kathleen Solotkin, Chen-Yen Lin, Kristin Kistler, Kathy Fraeman, Joseph Johnston, Lcdr Lesley Hawley, Nicholas Sicignano, Andre Araujo
BACKGROUND: Clinical trials impose exclusion criteria that may limit the generalizability of results. OBJECTIVES: To (a) determine the percentage of real-world patients who would qualify for psoriasis randomized controlled trials; (b) ascertain differences between moderate-to-severe psoriasis patients who would be eligible, ineligible, or potentially eligible for clinical trials; and (c) compare their biologic treatment patterns. METHODS: Moderate-to-severe psoriasis patients were identified from the U...
March 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28188433/the-clinical-effectiveness-of-ranibizumab-treat-and-extend-regimen-in-namd-systematic-review-and-network-meta-analysis
#2
REVIEW
Andriy Danyliv, Julie Glanville, Rachael McCool, Alberto Ferreira, Adrian Skelly, Ruth Pulikottil Jacob
INTRODUCTION: Neovascular age-related macular degeneration (nAMD) is a chronic eye condition that causes severe deterioration of vision and ultimately blindness. Two vascular endothelial growth factor inhibitors are approved for nAMD treatment in Europe: ranibizumab and aflibercept. The European license for ranibizumab was updated with an individualized "treat and extend" (T&E) regimen, which involves more proactive treatment based on changes in best corrected visual acuity (BCVA) and/or anatomical outcomes...
February 10, 2017: Advances in Therapy
https://www.readbyqxmd.com/read/28178263/novartis-snaps-up-selexys-for-sickle-cell
#3
Chris Morrison
No abstract text is available yet for this article.
February 8, 2017: Nature Biotechnology
https://www.readbyqxmd.com/read/28148221/motivations-for-non-participation-in-population-based-health-studies-among-the-elderly-comparison-of-participants-and-nonparticipants-of-a-prospective-study-on-influenza-vaccination
#4
Manas K Akmatov, Leonhard Jentsch, Peggy Riese, Marcus May, Malik W Ahmed, Damaris Werner, Anja Rösel, Jana Prokein, Inga Bernemann, Norman Klopp, Blair Prochnow, Thomas Illig, Christoph Schindler, Carlos A Guzman, Frank Pessler
BACKGROUND: Participation in epidemiological studies has strongly declined in recent years. We examined the reasons for (non)participation in population-based health studies among participants and nonparticipants of a prospective study on influenza vaccination among the elderly. METHODS: Males and females between 65 and 80 years of age (N = 5582) were randomly selected from the residents' registration office in Hannover, Germany, and were invited to participate in a study featuring vaccination with a seasonal adjuvanted influenza vaccine (Fluad™, Novartis) including five follow-up visits (day 0, 1/3, 7, 21, 70 with respect to vaccination)...
February 2, 2017: BMC Medical Research Methodology
https://www.readbyqxmd.com/read/28144918/a-retrospective-study-of-ranibizumab-treatment-regimens-for-neovascular-age-related-macular-degeneration-namd-in-australia-and-the-united-kingdom
#5
Robert L Johnston, Hans-Joachim Carius, Adrian Skelly, Alberto Ferreira, Fran Milnes, Paul Mitchell
INTRODUCTION: Neovascular age-related macular degeneration (nAMD) is the leading cause of vision loss among persons aged 65 years and older. Anti-vascular endothelial growth factor (anti-VEGF) treatment is the recommended standard of care. The current study compares the effectiveness of ranibizumab in routine clinical practice in two countries that generally apply two different treatment regimens, treat-and-extend (T&E) in Australia or pro re nata (PRN) in the UK. METHODS: This retrospective, comparative, non-randomised cohort study is based on patients' data from electronic medical record (EMR) databases in Australia and the UK...
January 31, 2017: Advances in Therapy
https://www.readbyqxmd.com/read/28131786/buparlisib-and-paclitaxel-in-patients-with-platinum-pretreated-recurrent-or-metastatic-squamous-cell-carcinoma-of-the-head-and-neck-beril-1-a-randomised-double-blind-placebo-controlled-phase-2-trial
#6
Denis Soulières, Sandrine Faivre, Ricard Mesía, Éva Remenár, Shau-Hsuan Li, Andrey Karpenko, Arunee Dechaphunkul, Sebastian Ochsenreither, Laura Anna Kiss, Jin-Ching Lin, Raj Nagarkar, László Tamás, Sung-Bae Kim, Jozsef Erfán, Anna Alyasova, Stefan Kasper, Carlo Barone, Sabine Turri, Arunava Chakravartty, Marie Chol, Paola Aimone, Samit Hirawat, Lisa Licitra
BACKGROUND: Phosphatidylinositol 3-kinase (PI3K) pathway activation in squamous cell carcinoma of the head and neck contributes to treatment resistance and disease progression. Buparlisib, a pan-PI3K inhibitor, has shown preclinical antitumour activity and objective responses in patients with epithelial malignancies. We assessed whether the addition of buparlisib to paclitaxel improves clinical outcomes compared with paclitaxel and placebo in patients with recurrent or metastatic squamous cell carcinoma of the head and neck...
January 25, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28130773/identification-of-substandard-medicines-via-disproportionality-analysis-of-individual-case-safety-reports
#7
Zahra Anita Trippe, Bruno Brendani, Christoph Meier, David Lewis
INTRODUCTION: The distribution and use of substandard medicines (SSMs) is a public health concern worldwide. The detection of SSMs is currently limited to expensive large-scale assay techniques such as high-performance liquid chromatography (HPLC). Since 2013, the Pharmacovigilance Department at Novartis Pharma AG has been analyzing drug-associated adverse events related to 'product quality issues' with the aim of detecting defective medicines using spontaneous reporting. The method of identifying SSMs with spontaneous reporting was pioneered by the Monitoring Medicines project in 2011...
January 28, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28126333/first-line-ceritinib-versus-platinum-based-chemotherapy-in-advanced-alk-rearranged-non-small-cell-lung-cancer-ascend-4-a-randomised-open-label-phase-3-study
#8
Jean-Charles Soria, Daniel S W Tan, Rita Chiari, Yi-Long Wu, Luis Paz-Ares, Juergen Wolf, Sarayut L Geater, Sergey Orlov, Diego Cortinovis, Chong-Jen Yu, Maximillian Hochmair, Alexis B Cortot, Chun-Ming Tsai, Denis Moro-Sibilot, Rosario G Campelo, Tracey McCulloch, Paramita Sen, Margaret Dugan, Serafino Pantano, Fabrice Branle, Cristian Massacesi, Gilberto de Castro
BACKGROUND: The efficacy of ceritinib in patients with untreated anaplastic lymphoma kinase (ALK)-rearranged non-small-cell lung cancer (NSCLC) is not known. We assessed the efficacy and safety of ceritinib versus platinum-based chemotherapy in these patients. METHODS: This randomised, open-label, phase 3 study in untreated patients with stage IIIB/IV ALK-rearranged non-squamous NSCLC was done in 134 centres across 28 countries. Eligible patients were assigned via interactive response technology to oral ceritinib 750 mg/day or platinum-based chemotherapy ([cisplatin 75 mg/m(2) or carboplatin AUC 5-6 plus pemetrexed 500 mg/m(2)] every 3 weeks for four cycles followed by maintenance pemetrexed); randomisation was stratified by World Health Organization performance status (0 vs 1-2), previous neoadjuvant or adjuvant chemotherapy, and presence of brain metastases as per investigator's assessment at screening...
January 23, 2017: Lancet
https://www.readbyqxmd.com/read/28125373/health-care-resource-utilization-and-costs-in-patients-with-chronic-myeloid-leukemia-with-better-adherence-to-tyrosine-kinase-inhibitors-and-increased-molecular-monitoring-frequency
#9
Dominick Latremouille-Viau, Annie Guerin, Patrick Gagnon-Sanschagrin, Katherine Dea, Benjamin G Cohen, George J Joseph
BACKGROUND: Frequent molecular monitoring (qPCR tests), as recommended by evidence-based monitoring guidelines, is associated with higher adherence to tyrosine kinase inhibitors (TKIs) in the management of chronic myeloid leukemia (CML); both factors have been associated with better clinical and economic outcomes. OBJECTIVES: To (a) estimate the effect of more frequent qPCR tests on health care resource utilization (HRU) and associated costs, including direct (effect of qPCR test frequency on HRU) and indirect (through TKI adherence) effects, and (b) develop an economic model applicable to multiple clinical practice scenarios...
February 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28125370/a-systematic-review-of-the-effect-of-cancer-treatment-on-work-productivity-of-patients-and-caregivers
#10
Khalid M Kamal, Jordan R Covvey, Ankur Dashputre, Somraj Ghosh, Surbhi Shah, Monali Bhosle, Christopher Zacker
BACKGROUND: Cancer is a leading cause of death with substantial financial costs. While significant data exist on the economic burden of care, less is known about the indirect costs of treatment and, specifically, the effect on work productivity of patients and their caregivers. To examine the full effect of cancer and the potential value of new therapies, all aspects of care, including indirect costs and patient-reported outcomes, should be evaluated. OBJECTIVE: To perform a systematic review of the literature examining the effect of cancer treatment on work productivity in patients and their caregivers...
February 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28125369/payer-perspectives-on-patient-reported-outcomes-in-health-care-decision-making-oncology-examples
#11
Andrew P Brogan, Carla DeMuro, Amy M Barrett, Denise D'Alessio, Vasudha Bal, Susan L Hogue
BACKGROUND: Health authorities and payers increasingly recognize the importance of patient perspectives and patient-reported outcomes (PROs) in health care decision making. However, given the broad variety of PRO endpoints included in clinical programs and variations in the timing of PRO data collection and country-specific needs, the role of PRO data in reimbursement decisions requires characterization. OBJECTIVES: To (a) determine the effect of PRO data on market access and reimbursement decisions for oncology products in multiple markets and (b) assess the effect of PRO data collected after clinical progression on payer decision making...
February 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28125366/treatment-patterns-and-overall-survival-associated-with-first-line-systemic-therapy-for-patients-with-advanced-non-small-cell-lung-cancer
#12
Michele M Spence, Rita L Hui, Jennifer T Chang, Joanne E Schottinger, Mirta Millares, Nazia Rashid
BACKGROUND: A variety of regimens are used as first-line treatment in patients with advanced non-small cell lung cancer (NSCLC), which may include combination regimens and single agents, depending on histology, molecular profile, and performance status. OBJECTIVE: To describe the types of first-line therapies and compare overall survival between therapies used for patients with advanced NSCLC in an integrated health care system. METHODS: This retrospective cohort study included patients aged 18 years or older from Kaiser Permanente California with a diagnosis of stage IIIB/IV NSCLC...
February 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28125362/duration-of-treatment-in-prostate-cancer-patients-treated-with-abiraterone-acetate-or-enzalutamide
#13
Dominic Pilon, Ajay S Behl, Lorie A Ellis, Bruno Emond, Patrick Lefebvre, Nancy A Dawson
BACKGROUND: Abiraterone acetate (AA) and enzalutamide (ENZ) are oral therapies offering survival benefit to metastatic castration-resistant prostate cancer (mCRPC) patients. Despite the availability of multiple treatment options for mCRPC, there is a lack of information on the effect that being initiated on AA or ENZ has on the combined prostate cancer treatment duration. OBJECTIVE: To compare the combined duration of prostate cancer treatments of patients initiated on AA with that of patients initiated on ENZ...
February 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28113163/what-lies-within-the-human-body-might-well-be-one-of-the-best-sources-for-new-antibiotics
#14
Shannon Fischer
In 1991, a group of Italian researchers announced that they had isolated a new antibiotic from a chemical soup brewed with a soil-dwelling bacteria called Planobispora rosea. The drug was a type of thiopeptide, effective against grampositive bacteria like Staphylococcus aureus, P. acnes, and C. difficile but uncooperative in terms of being harnessed for human medicines. Little came of that work until around 2012, when pharma giant Novartis reported that it had begun to experiment with the original drug's structure, ultimately creating a semisynthetic version with enough solubility that it could be effectively administered to human patients...
September 2016: IEEE Pulse
https://www.readbyqxmd.com/read/28090712/acad%C3%A3-mie-des-sciences-prizes-novartis-chemistry-lectureship-2016-2017
#15
(no author information available yet)
No abstract text is available yet for this article.
January 16, 2017: Angewandte Chemie
https://www.readbyqxmd.com/read/28073840/fda-approval-summary-sonidegib-for-locally-advanced-basal-cell-carcinoma
#16
Denise Casey, Suzanne Demko, Stacy Shord, Hong Zhao, Huanyu Chen, Kun He, Alexander Putman, Whitney S Helms, Patricia Keegan, Richard Pazdur
On July 24, 2015, the U. S. Food and Drug Administration (FDA) approved sonidegib (ODOMZO®, Novartis) for treatment of patients with locally advanced basal cell carcinoma (laBCC) not amenable to curative surgery or radiation therapy. The approval was based on data from one randomized, double-blind, non-comparative trial of two doses of sonidegib administered to 230 hedgehog inhibitor-naïve patients with metastatic basal cell carcinoma (mBCC, n=36) or laBCC (n=194). Patients were randomized 2:1 to receive sonidegib 800 mg (n=151) or 200 mg (n=79) daily...
January 10, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28071266/biogen-s-portfolio-and-research-efforts-in-multiple-sclerosis-an-interview-with-dr-ralph-kern
#17
Ralph Kern
Ralph Kern speaks to Laura Dormer, Commissioning Editor: Dr Ralph Kern is Senior Vice President and Head of Worldwide Medical at Biogen in Cambridge, MA, USA. In this role, he oversees Biogen's global therapeutic, regional and country medical teams, global medical operations, as well as medical research and scientific communications functions. Prior to joining Biogen, he was head of the Neuroscience Medical Unit at Novartis Pharmaceuticals Corporation and held various medical and commercial leadership roles at Genzyme Corporation...
February 2017: Neurodegenerative Disease Management
https://www.readbyqxmd.com/read/28069568/novartis-is-under-investigation-for-allegedly-bribing-thousands-of-greek-doctors
#18
Owen Dyer
No abstract text is available yet for this article.
January 9, 2017: BMJ: British Medical Journal
https://www.readbyqxmd.com/read/28050320/changes-in-anterior-chamber-depth-after-phacoemulsification-in-pseudoexfoliative-eyes-and-their-effect-on-accuracy-of-intraocular-lens-power-calculation
#19
Sirel Gür Güngör, Ahmet Akman, Leyla Asena, Mustafa Aksoy, Almila Sarıgül Sezenöz
OBJECTIVES: To compare anterior chamber depth (ACD) changes after phacoemulsification surgery in patients with pseudoexfoliation syndrome (PEX) and normal patients using an anterior segment imaging method. Another aim of this study was to evaluate the effect of these changes on the accuracy of intraocular lens (IOL) power calculation and postoperative refraction. MATERIALS AND METHODS: Twenty-two eyes of 22 patients with PEX and 30 eyes of 30 normal patients who underwent uneventful phacoemulsification surgery and IOL implantation were included in the study...
December 2016: Turkish Journal of Ophthalmology
https://www.readbyqxmd.com/read/28044255/mavoglurant-augmentation-in-ocd-patients-resistant-to-selective-serotonin-reuptake-inhibitors-a-proof-of-concept-randomized-placebo-controlled-phase-2-study
#20
Daniel Rutrick, Dan J Stein, Ganesan Subramanian, Brian Smith, Maurizio Fava, Gregor Hasler, Jang-Ho Cha, Fabrizio Gasparini, Toni Donchev, Magdalena Ocwieja, Donald Johns, Baltazar Gomez-Mancilla
INTRODUCTION: To determine if mavoglurant (modified release) as an augmentation therapy to selective serotonin reuptake inhibitors (SSRIs) could have beneficial effects reducing Yale-Brown Obsessive Compulsive Scale (Y-BOCS) total score in patients with obsessive-compulsive disorder (OCD) resistant to SSRI treatment. METHODS: This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 2 study. Patients remained on their SSRI treatment and mavoglurant or placebo was added on...
January 2, 2017: Advances in Therapy
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