Sentences with phrase «from efficacy studies»

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

Not exact matches

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.

Detailed 48 - week results from a Phase 3 study evaluating the efficacy and safety of switching from a regimen containing abacavir, dolutegravir and lamivudine (600 / 50/300 mg)(ABC / DTG / 3TC) to Biktarvy, a once - daily single tablet regimen, in virologically suppressed adults with HIV.

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).

Presentations will highlight the short and long - term effects of Ingrezza on tardive dyskinesia symptoms by body region, long term safety and efficacy data from the KINECT 4 phase 3 open label study and also from RE-KINECT (real - world screening study of patients with possible TD).

However, the efficacy of carotenoid - rich foods in the prevention of vitamin A deficiency has been questioned in several recent studies, which reported little or no nutritional benefit of vitamin A from the increased consumption of dark - green or yellow vegetables (11, 12).

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

BY NATHAN RILEY Outraged that Mayor Bill de Blasio continues to sit on a city health department study into the efficacy of establishing safe places for drug users to pursue their high — facilities that are in place all over Europe with proven track records of reducing fatal overdoses — protestors sat down in the middle of Broadway across from City Hall bringing downtown traffic to a halt.

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.

For many nutraceuticals, the most compelling evidence for efficacy remains anecdotal or, at best, based on hints of benefit from small or poorly controlled studies.

In the study, they reported that a PPMO designed to prevent creation of the AcrA protein significantly increased the efficacy of antibiotics against E. coli in cell models — from two - to 40-fold.

Twelve percent withdrew from the study for lack of efficacy.

The largest CBD study presented efficacy and safety data on GW Pharmaceutical's investigational medicine, Epidiolex (cannabidiol) from open - label Expanded Access programs at 16 sites.

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.

Apart from patient testimonials and a few preliminary studies in tumor cell lines and in mice, critics say, there is no evidence of the safety or efficacy of the compound, popularly known as the «cancer pill» or «fosfo.»

Prof Fortunato Ciardiello from Seconda Università degli Studi di Napoli, Italy, presented results from the CAPRI - Goim study on the efficacy of cetuximab plus FOLFOX chemotherapy as second - line treatment for patients with mCRC that progressed following FOLFIRI chemotherapy and cetuximab.

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.

Guided by findings from human and monkey studies, researchers are working to improve upon the efficacy of the RV144 vaccine regimen.

Recently, monkey studies testing vaccine regimens different from those in RV144 have supported the notion that enhancing protective antibody activity may increase vaccine efficacy.

Medical psychologist Jack D. Edinger of Duke University and his colleagues conducted a two - and - a-half-year study of 75 adults suffering from sleep maintenance insomnia in order to assess the efficacy of a form of cognitive behavioral therapy (CBT), as compared with relaxation therapy and placebo therapy.

Geisbert says the efficacy of the mix may have been due to the antibodies; past studies that he and others have conducted have found no effect on Ebola from interferon itself, he says.

In the first study of the drug lorcaserin in the human brain, the research revealed the mechanism underlying the drug's efficacy and provides insight into which individuals may benefit most from the medication.

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.

Because MVA was never tested in a real outbreak, data on its efficacy will have to come from animal studies.

The standard pharmaceutical development path for products that target pathogens moves slowly from studying safety, dosing, and biological responses in hundreds of people to an expensive efficacy trial with thousands of participants at high risk of becoming naturally infected.

Results from two studies, involving a total of 2892 Italian employees, provide evidence of the added value of a more comprehensive approach to the assessment of self - efficacy at work.

In a few weeks, meeting participants learned, enough data may be available from small phase I trials of a vaccine jointly made by the U.S. National Institute of Allergy and Infectious Diseases and GlaxoSmithKline (GSK) that began in September to launch efficacy studies.

We hope to move from the safety study into a full scale efficacy study in the spring, involving more patients in centres around the UK and Europe.

In the study, mice given a lethal dose of dengue virus less than a week after receiving the protective DMAb were completely protected from lethal disease — significantly more rapid than vaccine - driven protection, which can take weeks to months to reach peak efficacy levels.

The results from our new study suggest that entinostat may enhance the anti-tumor efficacy of PD - 1 targeted therapy through MDSC targeting, potentially providing an effective combination treatment approach for patients with solid tumors, including lung and renal cell carcinoma.»

Furberg says, «If only one in a thousand patients will die from a heart attack, an efficacy study of 200 or even 2,000 patients is simply too small to get a reliable answer about rare side effects.»

«We are exploring alternative directions for developing this compound, including potential use of the animal efficacy rule,» Cihlar said, referring to a regulatory mechanism under which the U.S. Food and Drug Administration may consider efficacy findings from adequate and well - controlled animal studies of a drug in cases where it is not feasible or ethical to conduct human trials.

The newly published PLOS ONE study assessed the long - term efficacy of the therapy and demonstrated that a single gene therapy treatment led to prolonged production of VNA in blood and protected the mice from subsequent exposures to C. botulinum toxin for up to several months.

«We're looking forward to longer - term results to come in the next five years from various ongoing observational studies,» Dr. Arterburn said: The Utah Obesity Study, the Michigan Bariatric Surgery Collaborative, and large cohorts from Veterans Affairs health system and the HMO Research Network (including Group Health) and should yield important long - term information comparing the efficacy, safety, and costs of surgical and non-surgical care for severe obesity.

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.

Early results from a phase I, first in - human study indicate that a potential new class of drugs, RNA interference (RNAi) drugs, can be safely administered in humans, according to a researcher who presented data on the safety and preliminary efficacy of TKM - 080301 at the AACR Annual Meeting 2013, held in Washington, D.C., April 6 - 10.

Data from these studies indicate the safety and efficacy of Celvive's therapeutic approach.

With her $ 178,000 award, Dr. Chen from Stroke Rehabilitation Research will study the efficacy of home - based arm and hand exercise (HAHE) to improve upper limb dysfunction after TBI.

Researchers from the group of Gary L. Dunbar at Central Michigan University, Michigan, USA have recently shown the ability of adenovirally generated rat iPSCs to survive and differentiate in the striatum of rats [6], and now in a study in Stem Cells Translational Medicine, they focus on the efficacy of transplantation of these cells into the 3 - nitropropionic acid (3 - NP) rat model of HD [7], which induces cell death by energy - depleting mechanisms providing an accurate model of cell loss and replicates many features of the disease [8].

«Both the efficacy and safety results from the ARIEL3 study reinforce the important role of Rubraca in the treatment of recurrent ovarian cancer and expands the treatment options for patients and physicians battling this disease,» he said.

To evaluate the efficacy of artisanal CBD for patients with epilepsy, Robert Carson, MD, PhD, and colleagues performed a retrospective study of medical records obtained from Vanderbilt's BioVU resource.

«Since these molecules come from species other than humans, many studies must be done to evaluate their safety and efficacy in the context of treatment,» he says.

AST - VAC1 (antigen - presenting autologous dendritic cells) is an autologous cancer immunotherapy with promising efficacy and safety data from a Phase 2 study in Acute Myeloid Leukemia (AML).

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.

Published new efficacy and safety data from preclinical studies of AST - OPC1 in the peer - reviewed journal «Stem Cells Translational Medicine.»

A planned interim efficacy analysis was conducted based on 82 patients who completed at least 183 days of treatment, withdrew from the study, or died.

«I think a lot of our success comes from delivering the intervention using home - based approaches and building up people's self - efficacy so that they rely on themselves,» said study lead author Wendy Demark - Wahnefried, PhD, RD, of the University of Alabama at Birmingham Comprehensive Cancer Center.

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.