Sentences with phrase «safety and efficacy results»

These results highlight the challenges that physicians, patients, and policymakers face when safety and efficacy results are at odds with cost - effectiveness results,» the researchers write.

If large - scale trials can replicate safety and efficacy results, the drug could be approved for legal use by 2021.

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).

They have a vested interest in publishing studies that promote the use of their medications and failing to publish study results that call the efficacy or safety of their drugs into question.

«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.

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.

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.

These encouraging results in terms of safety and efficacy are paving the way for a new kind of treatment, not only for Still's disease, but other rare inflammatory diseases, too.

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.

«Results described in this manuscript provide a comprehensive characterization of the efficacy of the PMO antisense platform against Marburg virus in nonhuman primates and its safety profile in humans,» Bavari said.

At Merck Frosst Canada, I have been an integral part of the discovery of a new molecule, the testing of its mechanism of action, the validation of its safety and efficacy in Phase IIb and III clinical trials, the market approval of the resulting product, and the subsequent management of patients and their disease.

«The first year results from the CoreValve US Pivotal Trial support the safety and efficacy of this therapy in patients unsuitable for surgical aortic valve replacement,» said lead investigator Steven Yakubov, MD..

«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.

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.

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.

«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.

The development track will begin with a Phase I trial to test the vaccine regimen's safety and immunogenicity and depending on those study results, a larger efficacy study will follow.

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.

The drug was approved based on efficacy and safety results from a phase III trial presented earlier this year at the 2015 American Society of Clinical Oncology Annual Meeting.

This revolutionary study on the new delivery form of HMB has now resulted in several clinical studies showing safety and efficacy.

In 2002, the Women's Health Initiative, the first study of its kind to test the safety and efficacy of HRT, released results on the increased risk of breast cancer and stroke among menopausal women taking combined hormone replacement therapy.

Long - term safety and efficacy of a cholesterol - lowering diet in children with elevated low - density lipoprotein cholesterol: seven - year results of the Dietary Intervention Study in Children (DISC)

However, from looking at the trial study results, it seems that the efficacy and safety profile are similar to Tysabri.

Evaluation of the efficacy and safety of imidocloprid 10 % plus moxidectin 2.5 % spot - on in the treatment of generalized demodicosis in dogs: results of a European field study.

Results from the clinical trial recently appeared in the journal Stem Cells Translational Medicine and are the first to demonstrate the safety and efficacy of treating a naturally occurring, chronic inflammatory disease in cats with their own fresh, fat - derived stem cells.

There are mixed results on the efficacy and safety of using H2O2 as an emetic.

As a result, questions remain surrounding the outcomes, efficacy and safety of some birth control methods among obese women.