This malaria vaccine is being evaluated in a Phase 2
efficacy trial in children at this site.
Thailand Clinical Trials Development Trial MHRP, in collaboration with the P5, is planning
an efficacy trial in a high - risk population of men who have sex with men (MSM) to hopefully improve upon the RV144 result and extend its relevance to at - risk populations to achieve the greatest public health impact.
«The next steps are to move ahead with a larger
efficacy trial in West Africa.»
[NIAID Director Anthony] Fauci says $ 56 million of the total would go toward a larger
efficacy trial in Liberia, which would include both the NIAID / GSK [GlaxoSmithKline] vaccine and another made by NewLink Genetics of Ames, Iowa (pending more data from ongoing safety trials).»
Efficacy trials in Brazil, Panama, and the Cayman Islands showed that this approach has helped reduce the Aedes aegypti population by more than 90 percent, Oxitec said.
Not exact matches
In particular, the complaint alleges that throughout the Class Period, defendants made materially false and / or misleading statements and / or failed to disclose that (1) the trials for GED - 0301 suffered from fatal design defects, such that GED - 0301 had failed to demonstrate meaningful clinical efficacy; (2) the growth of Otezla sales had dramatically slowed during Celgene's third fiscal quarter of 2017; and (3) the clinical and nonclinical pharmacology data in Celgene's new drug application («NDA») for Ozanimod were insufficient to permit a complete review by the FDA, which resulted in the FDA issuing a refusal to file letter to Celgene regarding the ND
In particular, the complaint alleges that throughout the Class Period, defendants made materially false and / or misleading statements and / or failed to disclose that (1) the
trials for GED - 0301 suffered from fatal design defects, such that GED - 0301 had failed to demonstrate meaningful clinical
efficacy; (2) the growth of Otezla sales had dramatically slowed during Celgene's third fiscal quarter of 2017; and (3) the clinical and nonclinical pharmacology data
in Celgene's new drug application («NDA») for Ozanimod were insufficient to permit a complete review by the FDA, which resulted in the FDA issuing a refusal to file letter to Celgene regarding the ND
in Celgene's new drug application («NDA») for Ozanimod were insufficient to permit a complete review by the FDA, which resulted
in the FDA issuing a refusal to file letter to Celgene regarding the ND
in the FDA issuing a refusal to file letter to Celgene regarding the NDA.
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.
Actual results and the timing of events could differ materially from those anticipated
in the forward - looking statements due to these risks and uncertainties as well as other factors, which include, without limitation: the uncertain timing of, and risks relating to, the executive search process; risks related to the potential failure of eptinezumab to demonstrate safety and
efficacy in clinical testing; Alder's ability to conduct clinical
trials and studies of eptinezumab sufficient to achieve a positive completion; the availability of data at the expected times; the clinical, therapeutic and commercial value of eptinezumab; risks and uncertainties related to regulatory application, review and approval processes and Alder's compliance with applicable legal and regulatory requirements; risks and uncertainties relating to the manufacture of eptinezumab; Alder's ability to obtain and protect intellectual property rights, and operate without infringing on the intellectual property rights of others; the uncertain timing and level of expenses associated with Alder's development and commercialization activities; the sufficiency of Alder's capital and other resources; market competition; changes
in economic and business conditions; and other factors discussed under the caption «Risk Factors»
in Alder's Annual Report on Form 10 - K for the fiscal year ended December 31, 2017, which was filed with the Securities and Exchange Commission (SEC) on February 26, 2018, and is 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).
Announced a clinical
trial collaboration with Pfizer, Inc. (Pfizer) to evaluate the safety and
efficacy of the investigational combination of Yescarta and Pfizer's utomilumab, a fully humanized 4 - 1BB agonist monoclonal antibody,
in patients with refractory large B - cell lymphoma.
«The positive
efficacy results observed
in the pivotal phase 3 clinical
trials indicate that sarecycline can be an effective treatment option for patients with moderate to severe acne,» said Allergan R&D chief David Nicholson
in a statement.
We do this by conducting clinical
trials in which we collect safety and
efficacy data about our experimental drugs with the goal of submitting those data to regulatory authorities, like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), so that these experimental drugs can be approved for use by patients.
A stroke drug invented at The Scripps Research Institute has shown signs of safety and
efficacy in a mid-stage clinical
trial.
In a March 16 research note, Andrew Fein, an analyst at H.C. Wainwright & Co., reported that OvaScience (OVAS: NASDAQ) shifted its focus back to research and development, after interim data from the first 20 patients in its Phase 1 trial of OvaPrime showed no signs of efficacy despite indicating safety and tolerabilit
In a March 16 research note, Andrew Fein, an analyst at H.C. Wainwright & Co., reported that OvaScience (OVAS: NASDAQ) shifted its focus back to research and development, after interim data from the first 20 patients
in its Phase 1 trial of OvaPrime showed no signs of efficacy despite indicating safety and tolerabilit
in its Phase 1
trial of OvaPrime showed no signs of
efficacy despite indicating safety and tolerability.
But oliceridine's value proposition actually depends on how well it stacks up against morphine from both a safety and
efficacy standpoint, which is the secondary endpoint
in each
trial.
Most biotechs would have shuttered a clinical program that showed absolutely no
efficacy whatsoever
in a late - stage
trial, but Novavax has instead doubled down on RSV by going forth with its phase 3
trial of the RSV F vaccine for infants via maternal immunization, and begun planning for another
trial in older adults that's reportedly on track to kick off
in 2018.
Efficacy of tart cherry juice
in reducing muscle pain during running: a randomized controlled
trial.
A systematic review of the
efficacy of herbal galactagogues published
in the Journal on Lactation found five
trials that showed an increase
in breast milk production.
The
efficacy of malunggay (moringa oleifera) given to near term pregnant women
in inducing early postpartum breast milk production - a double blind randomized clinical
trial.
The aim of this
trial is to evaluate the safety and
efficacy of continuous KMC initiated immediately after birth compared to the current recommendation of initiating continuous KMC after stabilization,
in improving survival of neonates with birth weight from 1.0 to < 1.8 kg.
In the third
trial of the nurse home visitor program, nurse - visited, 6 - month - old infants born to mothers with low psychological resources (i.e., maternal IQ, mental health, and sense of
efficacy) displayed fewer aberrant emotional expressions (e.g., low levels of affect and lack of social referencing of mother) associated with child maltreatment.18
The DAME
trial was a multi-site, randomised controlled
trial of antenatal expression of colostrum
in late pregnancy for women with diabetes
in pregnancy to explore the safety and
efficacy for mother, foetus and infant.
The
trial was designed to test the safety and
efficacy of omega - 3 — fortified formulas compared with unfortified formulas or breast milk
in 288 premature infants.
Safety and
efficacy of antenatal milk expressing for women with diabetes
in pregnancy: protocol for a randomised controlled
trial.
A randomized
trial assessing the
efficacy of peer counseling on exclusive breastfeeding
in a predominantly Latina low - income community
In recent years, medical researchers have proven its efficacy in clinical trial
In recent years, medical researchers have proven its
efficacy in clinical trial
in clinical
trials.
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
The
efficacy of these treatments for other anxiety disorders
in children and adolescents has been supported by multiple randomized controlled
trials (e.g., Walkup et al., 2008).
Its role
in the initiation of labour is poorly understood and data examining its
efficacy within a clinical
trial are limited.
Efficacy of an online breastfeeding tutorial and maternal needs assessment
in increasing breastmilk - only feeding
in a pediatric practice: results of a randomized controlled
trial
«A future clinical
trial for NMN will tell us if it has any
efficacy in humans.»
«This phase III
trial will be noteworthy for being the first prostate cancer
trial to assess a biomarker, namely AR - V7
in circulating tumour cells, as a predictor of response at the same time as testing the
efficacy of the drug,» Prof Taplin will conclude.
Thomas Smith, who studies the epidemiology of malaria at the Swiss Tropical Institute
in Basel, says it may be premature to say exactly what the
efficacy is based on this early data from the
trial, which is still ongoing.
Although gene therapy research has made great strides
in recent years, it has yet to be widely deployed, and no CRISPR - edited genes have yet been tested for safety or
efficacy in human clinical
trials.
This open label, multicentre, phase 1B
trial investigated the safety and
efficacy of omaveloxolone
in combination with the checkpoint inhibitors ipilimumab or nivolumab.
The three - armed
trial evaluated the
efficacy of chiropractic spinal manipulative therapy (CSMT)
in the treatment of migraine versus placebo (sham chiropractic) and control (usual drug treatment).
«The study results elucidate the molecular mechanisms underlying disease progression
in multiple sclerosis models, providing a basis for future clinical
trials to determine safety and
efficacy of these chemical agents
in humans with demyelinating disorders,» says Patrizia Casaccia, MD, PhD, Professor of Neuroscience, Genetics and Genomic Sciences at Mount Sinai and senior author of the study.
If it appears safe, Inovio plans to test its
efficacy in field
trials among Zika - affected populations
in the Caribbean later this year, says Inovio CEO Joseph Kim.
«Randomized
trials have confirmed the value of radiation dose escalation for prostate tumors, and the potential benefits of larger radiation doses
in fewer fractions, are expected to increase the therapeutic
efficacy for men with prostate cancer,» said Anders Widmark, MD, a professor of radiation sciences at Umeå University
in Umeå, Sweden and lead author of the study.
She has created toxin - smothering antibodies that have been shown to be safe
in humans by Caprion Pharmaceuticals, paving the way for
efficacy trials.
Boni E. Elewski, M.D., professor of dermatology, is the principal investigator of the
Efficacy of Response And Safety of two fixed secUkinumab REgimens
in psoriasis (ERASURE)
trial, one of two studies
in the recent New England Journal of Medicine article «Secukinumab
in Plaque Psoriasis — Results of Two Phase 3
Trials.»
«The combined results of ERASURE, along with the FIXTURE
trial, are very exciting
in terms of the
efficacy and safety of secukinumab,» Elewski, co-lead author, said.
Previous clinical
trials of creatine
in symptomatic HD patients have been limited
in scale, involved daily doses of 10 grams or less, and did not provide evidence of potential
efficacy.
More than 5,000 people
in Guinea received the vaccine
in a
trial to gauge its
efficacy.
The company plans
in October to conduct a separate test specifically to study the seasonal flu vaccine's effectiveness among 480 elderly participants (a demographic often encouraged to get seasonal flu shots), and Phase III
efficacy trials across a larger set of demographics are scheduled to begin early next year.
The researchers hope that ultimately human
trials will prove the
efficacy of the OH14 compound
in sensitising tumour cells and cancer stem cells to existing drug - based therapies thus disabling tumours from seeding new growth after treatment.
Respondents
in this year's survey pointed to five main causes of the field's less than favorable reputation: drug and product recalls such as the withdrawal of Avandia; safety issues such as the discovery of problems with raw material from China used
in medical products; scandals, including evidence that pharmaceutical companies have failed to release data from
trials whose results cast doubts on their drugs» safety and
efficacy; lawsuits brought against companies that failed to warn patients of problems with their products; and ethical issues such as kickbacks for physicians promoting specific medications.
Schlom, of the National Cancer Institute, says the next challenge for researchers is to find ways to combine different immunotherapy drugs into single treatments and measure their
efficacy in clinical
trials.
And scientists who conduct human challenge studies, which typically involve a few dozen participants, say they have critical benefits:
In addition to saving time and money, they can reveal harm caused by a potential drug or vaccine before it enters large - scale human
efficacy trials.
Only a clinical
trial that combines azacitidine with the blinded addition of either vitamin C or a placebo will give the true answer as to whether or not vitamin C increases the
efficacy of azacitidine
in patients.