Sentences with phrase «clinical efficacy studies»

Can you tell us briefly about the results of clinical efficacy studies?

Not exact matches

Last year The Ohio State University Wexner Medical Center began clinical trials on the efficacy of SuperBetter to treat traumatic brain injuries, and the University of Pennsylvania Positive Psychology Center greenlighted a randomized controlled user study of the game to treat depression.

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).

Multicenter study of the lactational amenorrhea method (LAM): I. Efficacy, duration, and implications for clinical application.

Whilst there are no RCT studies available at this time to draw definitive conclusions about the efficacy of this process, many clinical reports exist to indicate that placenta encapsulation is helpful in the postpartum period in terms of increasing milk supply (acting as a galactagogue) and improving mood in the postpartum period.

Luke's Medical Center and at the Rehabilitation Institute about doing clinical studies to demonstrate the efficacy of her firm's brand of adult diapers called Rejoice.

Summary: This study, published in the American Journal of Clinical Nutrition in November 2009, investigated the efficacy of multivitamin supplements at single...

The study, «The efficacy of the BCG vaccine against newly emerging clinical strains of Mycobacterium tuberculosis,» was published in the journal PLOS One in September.

«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.

Following the success of this preliminary safety and feasibility study, more patients are being recruited for a larger clinical trial of the procedure to test the efficacy and durability of the procedure.

The main objective of this study was to verify the safety of the drug and to confirm its efficacy on the clinical manifestations of the disease.

The determination of each efficacy level was also based on the rigor and quantity of published studies on the drug class: to be in Level A, for example, a class of drugs must have been supported by at least two «Class I» studies — well - designed, double - blind, randomized, placebo - controlled clinical trials.

Three studies presented at the American Epilepsy Society's 69th Annual Meeting in Philadelphia highlight emerging efficacy and safety data of Epidiolex, a pharmaceutical liquid formulation of cannabidiol, which is currently undergoing U.S. Food and Drug Administration (FDA) authorized Phase 3 pivotal clinical trials in the United States and across the globe by GW Pharmaceuticals.

With the initial contract of $ 24.9 million over the next 18 months, Mapp Pharmaceutical will manufacture a small amount of the drug for early - stage clinical studies to demonstrate its safety and efficacy in people.

The documentation ranges across the whole spectrum of drug development: Investigators» brochures provide information on all that is currently known about the medicine and so need periodic updating; accurate and concise protocols are required to ensure that trials are performed effectively; clinical trial reports (generally from phase II and III studies) present the information gathered from the trials; higher level documents provide summaries of efficacy and safety data from clinical trial programmes; expert reports provide critical interpretation of the results; and response documents clarify any points that are not clear to the regulatory agencies or provide additional analyses or supporting data for any items of concern.

Furthermore, the report accuses the British Homeopathic Association (BHA), which had submitted evidence to the panel, of cherry - picking, and even, in one case actively misrepresenting, research into the treatment (a famous study that concluded its findings were «compatible with the notion that the clinical effects of homeopathy are placebo effects» was cited by the BHA as evidence of the treatment's efficacy.)

«The efficacy and toxicity need to be validated in clinical studies, but I think the potential is there.»

Despite small clinical studies that have reported efficacy of the approach, the mechanism of action is poorly understood.

They will also be conducting clinical studies to examine the efficacy of delivering collagen for cosmetic and skincare purposes.

The data obtained from this study provide a basis for more rapid, cost - effective clinical trials to evaluate new influenza drugs or to determine the efficacy of candidate vaccines for both seasonal and pandemic influenza.

Pharmacogenomics — the study of how genes affect responses to drugs — is becoming more important in drug - development research and clinical trials, with a view toward decreasing side effects and increasing the efficiency and efficacy of drugs in patients with the right genetic profiles.

Results from recent clinical trials and studies in animals suggest that a class of anti-cancer drugs called angiogenesis inhibitors may be able to temporarily reduce interstitial pressure and improve the efficacy of chemotherapy and radiation treatments.

The safety and efficacy of these methods have been well established through long - term clinical outcomes studies in the field, with the nasal lining protecting the brain from infection just as the blood brain barrier has done.

If these preclinical studies are successful, the researchers plan to further develop their CAR T cell therapy and test its safety and efficacy for different types of metastatic cancer in upcoming clinical trials.

Indeed, this study shows that the therapeutic efficacy of a new drug that is currently in clinical trial depends on Sestrin1.

«When each of the clinicians or clinical teams that have been using ZMapp release their data, we'll get a better sense of maybe the efficacy, but even then, it's hard because it's not really a designed study,» Kobinger said.

Promising outcomes of preliminary studies in patients in Southeast Asia and parts of Western and Central Africa led the World Health Organization to make the recommendation, but safety and efficacy have not yet been proven in large - scale clinical trials.

According to Dr. Fonseca, who studies the efficacy of new diabetes agents as the principal investigator of numerous clinical trials, «New medications offer more options for us and our patients.

The GP practices were involved in ensuring the study not only had access to specific COPD patients but also that the usual clinical care provided by the practices was built into the trials — the study was therefore rooted in a real clinical environment unlike tradition efficacy trial model.

«Our findings challenge the automatic transfer of findings from efficacy studies to clinical guidelines or everyday clinical practice,» said Prof Vestbo.

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.

The study, «The efficacy of the BCG vaccine against newly emerging clinical strains of Mycobacterium tuberculosis,» was published in September.

Further studies of ALN - TTR02 are needed to examine the clinical efficacy and safety of long - term transthyretin knockdown in patients with familial amyloidotic polyneuropathy.

A Houston Methodist team led by Mauro Ferrari, PhD and Jenny Chang, MD has received funding from the U.S. Department of Defense to complete preclinical efficacy studies and a future clinical trial testing a breast cancer precision drug.

While we can not predict the outcome of any future safety or efficacy studies, this decision by FDA allowing clinical research to begin represents a major milestone in allowing us to hopefully provide answers to those critical questions in the future,» Conn said.

SEATTLE, WA and DURHAM, NC — The HIV Vaccine Trials Network (HVTN) and the HIV Prevention Trials Network (HPTN) today announced the initiation of HVTN 704 / HPTN 085, also known as Antibody Mediated Prevention (AMP) or the AMP Study, a Phase 2b clinical trial to evaluate the safety and efficacy of VRC01, a broadly neutralizing monoclonal antibody (bnAb).

The purpose of this study is to examine the response to and clinical efficacy of a new drug, «BAN2401», in subjects with Early Alzheimer's Disease.

Based on proof - of - concept pre-clinical studies indicating robust efficacy and favorable safety profile, the company is now advancing to conduct a clinical trial testing the efficacy of this new treatment.

Kessler Foundation has been using Ekso Bionics» exoskeleton for clinical research in patients with spinal cord injury since October 2011 and recently acquired a second device to study utility and efficacy specifically for stroke survivors.

The first clinical trial was a safety study in Australia, followed by an ongoing efficacy study in Peru to evaluate the ability to treat patients with malaria.

Among this class of derivatives, compound 2 (AMD070, AnorMED) is particularly notable due to its significant anti-HIV efficacy in human clinical studies [86].

While not designed or powered as an efficacy study, there were also encouraging hints of clinical benefit in PD01A - treated patients.

In this presentation, we discuss data from studies conducted with academic, clinical, and industry collaborators that demonstrates the utility of the system as a more predictive, human - relevant alternative for efficacy and safety testing of new chemical entitites.

It exhibited safety in animal studies, and preliminary evidence of both target engagement and clinical efficacy in its Phase I and Phase II trials.

Although these studies were limited to small patient numbers, given the rarity of this disease, PD - 1 pathway blockade seems to have clinical efficacy in mucosal melanoma, with a tolerable safety profile.

Its Clinical Trials Center conducts 13 - 15 clinical studies per year, and in December initiated a Phase 2 clinical trial of an Ebola vaccine following its groundbreaking first - in - human testing of the Ebola vaccine that showed efficacy in Guinea laClinical Trials Center conducts 13 - 15 clinical studies per year, and in December initiated a Phase 2 clinical trial of an Ebola vaccine following its groundbreaking first - in - human testing of the Ebola vaccine that showed efficacy in Guinea laclinical studies per year, and in December initiated a Phase 2 clinical trial of an Ebola vaccine following its groundbreaking first - in - human testing of the Ebola vaccine that showed efficacy in Guinea laclinical trial of an Ebola vaccine following its groundbreaking first - in - human testing of the Ebola vaccine that showed efficacy in Guinea last year.

Paris, France, April 3, 2018, 5.35 pm CET — GenSight Biologics (Euronext: SIGHT, ISIN: FR0013183985, PEA - PME eligible), a biopharma company focused on discovering and developing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today announced topline results from the REVERSE Phase III clinical trial evaluating the safety and efficacy of a single intravitreal injection of GS010 (rAAV2 / 2 - ND 4) in 37 subjects whose visual loss due to 11778 - ND4 Leber Hereditary Optic Neuropathy (LHON) commenced between 6 and 12 months prior to study treatment.

Using data from the AHRQ report, the Institute for Clinical and Economic Review (ICER, 2011) conducted a cost - effectiveness modeling study, assuming that transcranial electrical stimulation and electroconvulsive therapy have equivalent efficacy.

In a phase II study, voxtalisib, which targets all four class I PI3Ks, had efficacy in FL but limited clinical effect in MCL, DLBCL, and CLL / SLL.