Sentences with phrase «efficacy rate in»

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These risks and uncertainties include, among others: the unfavorable outcome of litigation, including so - called «Paragraph IV» litigation and other patent litigation, related to any of our products or products using our proprietary technologies, which may lead to competition from generic drug manufacturers; data from clinical trials may be interpreted by the FDA in different ways than we interpret it; the FDA may not agree with our regulatory approval strategies or components of our filings for our products, including our clinical trial designs, conduct and methodologies and, for ALKS 5461, evidence of efficacy and adequacy of bridging to buprenorphine; clinical development activities may not be completed on time or at all; the results of our clinical development activities may not be positive, or predictive of real - world results or of results in subsequent clinical trials; regulatory submissions may not occur or be submitted in a timely manner; the company and its licensees may not be able to continue to successfully commercialize their products; there may be a reduction in payment rate or reimbursement for the company's products or an increase in the company's financial obligations to governmental payers; the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company's products; the company's products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading «Risk Factors» in the company's most recent Annual Report on Form 10 - K and in subsequent filings made by the company with the U.S. Securities and Exchange Commission («SEC»), which are available on the SEC's website at www.sec.gov.
These risks and uncertainties include: Gilead's ability to achieve its anticipated full year 2018 financial results; Gilead's ability to sustain growth in revenues for its antiviral and other programs; the risk that private and public payers may be reluctant to provide, or continue to provide, coverage or reimbursement for new products, including Vosevi, Yescarta, Epclusa, Harvoni, Genvoya, Odefsey, Descovy, Biktarvy and Vemlidy ®; austerity measures in European countries that may increase the amount of discount required on Gilead's products; an increase in discounts, chargebacks and rebates due to ongoing contracts and future negotiations with commercial and government payers; a larger than anticipated shift in payer mix to more highly discounted payer segments and geographic regions and decreases in treatment duration; availability of funding for state AIDS Drug Assistance Programs (ADAPs); continued fluctuations in ADAP purchases driven by federal and state grant cycles which may not mirror patient demand and may cause fluctuations in Gilead's earnings; market share and price erosion caused by the introduction of generic versions of Viread and Truvada, an uncertain global macroeconomic environment; and potential amendments to the Affordable Care Act or other government action that could have the effect of lowering prices or reducing the number of insured patients; the possibility of unfavorable results from clinical trials involving investigational compounds; Gilead's ability to initiate clinical trials in its currently anticipated timeframes; the levels of inventory held by wholesalers and retailers which may cause fluctuations in Gilead's earnings; Kite's ability to develop and commercialize cell therapies utilizing the zinc finger nuclease technology platform and realize the benefits of the Sangamo partnership; Gilead's ability to submit new drug applications for new product candidates in the timelines currently anticipated; Gilead's ability to receive regulatory approvals in a timely manner or at all, for new and current products, including Biktarvy; Gilead's ability to successfully commercialize its products, including Biktarvy; the risk that physicians and patients may not see advantages of these products over other therapies and may therefore be reluctant to prescribe the products; Gilead's ability to successfully develop its hematology / oncology and inflammation / respiratory programs; safety and efficacy data from clinical studies may not warrant further development of Gilead's product candidates, including GS - 9620 and Yescarta in combination with Pfizer's utomilumab; Gilead's ability to pay dividends or complete its share repurchase program due to changes in its stock price, corporate or other market conditions; fluctuations in the foreign exchange rate of the U.S. dollar that may cause an unfavorable foreign currency exchange impact on Gilead's future revenues and pre-tax earnings; and other risks identified from time to time in Gilead's reports filed with the U.S. Securities and Exchange Commission (the SEC).
We would be more constructive on the efficacy of immediate expensing as a stimulus if tax writers allow tax carry forward losses to accrue an annual real rate of return as prescribed in the House bill (H.R. 1).
The technology measures the stage of disease, rate of progression of disease, drug efficacy, and drug toxicity in several cancers and Alzheimer's disease.
Short - term rates have limited efficacy in affecting term premium in recent decades amid unconventional easing:
In recognizing the catalysts behind the public's persistence to save and reluctance to spend, additional analysis by policymakers should focus on the efficacy of further rate cuts on spending and investment, as well as potential «roundabout» benefits of a more normal rates regime to affirm support toward the public's saving objectives, with the end goal of boosting public's risk sentiment and perceptions of future economic stability.
Federal Reserve micro-management of short - term rates led to undue certainty in the markets over the efficacy of monetary policy — «The Great Moderation.»
The brief includes the analysis of survey data from program participants on child safety in the home, observed parenting practices, parental stress and parenting efficacy, self - reported parenting practices, and rates of child maltreatment.
• Assumptions about different cultural groups and how they impact breastfeeding support • Shoshone and Arapaho tribal breastfeeding traditions shared through oral folklore • Barriers to decreasing health disparities in infant mortality for African Americans • Effects of inflammation and trauma on health disparities that result in higher rates of infant mortality among minority populations • Barriers to breastfeeding experienced by Black mothers and how lactation consultants can support them more effectively • Social support and breastfeeding self - efficacy among Black mothers • Decreasing pregnancy, birth, and lactation health disparities in the urban core • Positive changes in breastfeeding rates within the African American community • Grassroots breastfeeding organizations serving African American mothers
Although professional lactation support can improve the duration of overall breast feeding, its effect in improving exclusive breast feeding is unclear.11 18 22 Thus far, studies that report improvement of rates of exclusive breastfeeding have involved mainly community based peer counselling strategies.23 24 25 Even then, a randomised trial in the UK recently cast doubt on the efficacy of this approach.26 There are current recommendations from NICE for the UK - wide implementation of the baby friendly initiative.4 5 6 The 2006 NICE costing report on routine postnatal care of women and their babies estimates that efforts to improve rates of breast feeding will result in substantial cost savings for the NHS.6
Today's unequal electoral participation rates reflect underlying inequalities in levels of political participationmore broadly, and — critically — perceptions of the fairness and efficacy of British democracy.
In the new study, the method accurately predicted vaccine efficacy rates for more than 40 years of flu records.
«Climbers who rated as high in self - efficacy engaged in riskier climbs — they do more climbing, too,» Jones says.
In collaboration with many researchers (graduate students, postdocs, and faculty elsewhere), we have examined the role of cross-immunity on the evolution and dynamics of influenza; the impact of behavioral changes, long periods of infectiousness, variable infectivity, co-infections, prostitution, social networks, and vaccine efficacy on HIV dynamics; the role of exogenous re-infection, variable progression rates, vaccination, public transportation, close and casual contacts on tuberculosis dynamics and control; the impact of life - history vector dynamics on dengue epidemics; and on the identification of time - response scales for epidemics of foot and mouth disease.
«Our population in this trial also had a high response rate in the control group, so further studies are needed in broader populations to assess the efficacy of buprenorphine implants versus sublingual buprenorphine in other settings.»
Conventional drug discovery remains a hit - and - miss affair and Hunter believes the 50 percent failure rates seen for experimental compounds in mid - and late - stage clinical trials due to lack of efficacy is unsustainable, forcing a shift to AI.
Long - term ETV or TDF therapy is the most common treatment option in CHB of any severity, but efficacy data have been mainly based upon on - therapy virological remission rates.
Depletion of gram - positive bacteria within the gut, using an antibiotic called vancomycin, also increased the efficacy of the therapy, improving the anti-tumor response and overall remission rate in less - responsive mice.
Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of Syndax's collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes.
Title: Combining efficacy and completion rates with no data imputation: a composite approach with greater sensitivity for the statistical evaluation of active comparisons in antipsychotic Trials Author: J. Rabinowitz et al..
The combination of pomalidomide plus low - dose dexamethasone showed efficacy with high rates of disease control in relapsed or refractory multiple myeloma patients with severe renal impairment, according to the results of a phase II study.
[44] Two other phase II clinical trials evaluated the efficacy of imatinib in patients with melanoma — including mucosal melanomas — harboring KIT mutations and / or amplifications, with a subset of cases involving mucosal primaries, and both found a disease control rate of approximately 50 %.
Students» ratings of various aspects of the class environment are connected to their engagement in class, motivation to learn, sense of self - efficacy, and achievement.
«This brief offers relevant, scholarly research directly from the education community to help college access practitioners mitigate the problem of low college completion rates, especially among underrepresented student groups,» said IHEP President Michelle Asha Cooper, Ph.D. «With an increased national focus on postsecondary degree completion, understanding the role of social supports can be the key to providing college access practitioners with strategies to create comprehensive structures and increase self - efficacy, which in turn, improves student success.»
CAP's report notes that the discussion of publishing teachers» names along with their value - added score (a measure of a teacher's efficacy, relative to other teachers in the group, in promoting student achievement) began when the Los Angeles Times published a report featuring the performance ratings for Los Angeles Unified School District teachers.
«Over 50 years of research links the various roles that families play in a child's education — as supporters of learning, encouragers of grit and determination, models of lifelong learning, and advocates of proper programming and placements for their child — with indicators of student achievement including student grades, achievement test scores, lower drop - out rates, students» sense of personal competence and efficacy for learning, and students» beliefs about the importance of education.»
Federal Reserve micro-management of short - term rates led to undue certainty in the markets over the efficacy of monetary policy — «The Great Moderation.»
From the method of administration to the efficacy to the near immediate kill rate, advancements in flea and tick medications over the past 25 years will impress anyone in the medical and scientific worlds.
However, given the potential reactions and newer and safer alternatives in many case situations, I give this prescription antibiotic an overall rating / efficacy of a 2.5 with a taste / ease of use of a 4.
Some of the available vaccinations are for diseases not found in Arizona or the vaccination may have conflicting or low efficacy rates or high rates of severe or life - threatening reactions.
In dogs with relapsed DLBCL, OR rate and PFST will be significantly better in dogs treated with a chemotherapy drug selected for optimal efficacy by BDI when compared to those for dogs treated with an empirically selected chemotherapy druIn dogs with relapsed DLBCL, OR rate and PFST will be significantly better in dogs treated with a chemotherapy drug selected for optimal efficacy by BDI when compared to those for dogs treated with an empirically selected chemotherapy druin dogs treated with a chemotherapy drug selected for optimal efficacy by BDI when compared to those for dogs treated with an empirically selected chemotherapy drug.
In other words ignoring the non-linear GHG efficacy curve of CO2 and the rate of anthropogenic deposition is just another attempt to hide a couple of inconvenient declines.
Geoengineering schemes need ranking system to avoid wasting money, destroying the planet (10/26/2008) Schemes to alter Earth's climate on a planetary scale should be ranked according to their efficacy, cost, risks and their rate of mitigation, argues a new editorial published in Nature Geoscience.
(10/26/2008) Schemes to alter Earth's climate on a planetary scale should be ranked according to their efficacy, cost, risks and their rate of mitigation, argues a new editorial published in Nature Geoscience.
Equilibrium and transient efficacies, and TCR and ECS estimates, were derived by comparing the historical GMST response (ΔT) with the causative forcing change (ΔF) respectively with and without the associated change in ocean heat uptake rate (ΔQ) deducted.
In fact, that's exactly what we would expect from a super-strong greenhouse effect: the whole point of the greenhouse effect is that it decreases the rate at which the planet can cool, by decreasing radiative efficacy at (local) thermal wavelengths.
Similarly, in Cochrane v Ontario, the Ontario Human Rights Tribunal found that the evidence did not prove that prostate cancer screening increased survival rates and thus, like in Armstrong, efficacy — not sex — was the motivation for the decision.
In pointing out the 97 % rent recovery rate I was not commenting on the efficacy of the Landlord & Tenant Board at all, but simply on the efficacy of being a landlord.
Professional Duties & Responsibilities Responsible for company customer service departments across multiple fields Hired, trained, directed, and reviewed customer service representatives Directed call center ensuring professional and efficient operations Increased company efficacy through the establishment of best practices Ensured professional and timely response to customer service inquiries Maintained extremely high client satisfaction rate resulting in repeat business Authored and presented customer service, finance, and personnel reports for senior leadership Tracked daily, weekly, and periodic customer service interactions Handled financial transactions including credit card payments, declines, and collections Resolved shipping, warranty, and product operation inquiries Oversaw the creation, update, and maintenance of client information database Maintained working knowledge of company products and services to best assist clients Built long - term relationships with employers, piers, clients, and industry leaders Assisted various company departments with special projects as needed Fostered an atmosphere of respect and dedication to company goals Performed all duties in a professional, positive, and timely manner
Parent ratings of child aggression were unchanged, however — a concern regarding its efficacy in preventing child abuse among this very high - risk group.
A high frequency of binge eating at baseline negatively impacted remission rates at posttreatment in BWL and CBTgsh, but had no effect on the efficacy of IPT.
Contrary to the meta - analyses of Crits - Christoph5 andAnderson and Lambert, 7 studies of IPT werenot included (eg, Elkin et al30 and Wilfleyet al31), because the relation of IPT to STPPis controversial, and empirical results suggest that IPT is very close toCBT.9 Thus, this review includes only studiesfor which there is a general agreement that they represent models of STPP.As it is questionable to aggregate the results of very different outcome measuresthat refer to different areas of psychological functioning, we assessed theefficacy of STPP separately for target symptoms, general psychiatric symptoms (ie, comorbid symptoms), and social functioning.32 Thisprocedure is analogous to the meta - analysis of Crits - Christoph.5 Asoutcome measures of target problems, we included patient ratings of targetproblems and measures referring to the symptoms that are specific to the patientgroup under study, eg, measures of anxiety for studies investigating treatmentsof anxiety disorders.33 For the efficacy ofSTPP in general psychiatric symptoms, broad measures of psychiatric symptomssuch as the Symptom Checklist - 90 and specific measures that do not refer specificallyto the disorder under study were included; eg, the Beck Depression Inventoryapplied in patients with personality disorders.34, 35 Forthe assessment of social functioning, the Social Adjustment Scale and similarmeasures were included.36
Overall efficacy (changes in Positive and Negative Syndrome Scale or in Brief Psychiatric Rating Scale), positive, negative and depressive symptoms, quality of life and relapse rates.
Adolescents, however, have a high treatment drop out rate.1 The well - conducted usual care may have reduced possible differences in efficacy of DGP.
The brief includes the analysis of survey data from program participants on child safety in the home, observed parenting practices, parental stress and parenting efficacy, self - reported parenting practices, and rates of child maltreatment.
Abstract: High unemployment rates for people with multiple sclerosis are frequently attributed to decreases in self - efficacy and outcome expectations with respect to job seeking and retaining tasks.
The mean relapse rate is 50 % at one year and over 70 % at four years.1 A recent prospective twelve year follow - up study showed that individuals with bipolar disorder were symptomatic for 47 % of the time.2 This poor outcome in naturalistic settings suggests an efficacy effectiveness gap for mood stabilisers that has resulted in a re-assessment of the role of adjunctive psychological therapies in bipolar disorder.3 Recent randomised controlled trials show that the combination of pharmacotherapy and about 20 — 25 sessions of an evidence - based manualised therapy such as individual cognitive behaviour therapy4 or family focused therapy5 may reduce relapse rates in comparison to a control intervention (mainly treatment as usual) in currently euthymic people with bipolar disorder.
Compared to the nonintervention sample across time, the Strong Communities samples showed significant changes in the expected direction for social support, collective efficacy, child safety in the home, observed parenting practices, parental stress, parental efficacy, self - reported parenting practices, rates of officially substantiated child maltreatment, and rates of ICD - 9 coded child injuries suggesting child maltreatment.
A recent efficacy trial found that those randomized to MBRP, as compared with those in a control group, demonstrated significantly lower rates of substance use and greater decreases in craving following treatment.
Since in clinical practice the popularity of mindfulness - based interventions for ADHD is rising, future studies should focus on gathering empirically sound evidence for the efficacy and effectiveness of mindfulness - based interventions, preferably including ratings of independent observers as outcomes.
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