Sentences with phrase «safety trials on»
Wyss - Coray was critical of this trial, but Alkahest, a company he co-founded, recently completed its own more rigorous small safety trial on 18 Alzheimer's patients with «no adverse side effects.»
https://www.scientificamerican.com/ 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.
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).
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.
The safety and integrity of Australian red meat is being further bolstered following recent trials of new cutting - edge microwave technology, aimed at consumers who prefer their meat on the rare side of the cooking spectrum.
In a public dialogue on Golden Rice held by the National Anti-Poverty Commission or NAPC last August, medical doctors has warned that there are not enough data presented to establish safety of Golden Rice to human health thus warranting the discontinuation of human feed trials.
A technical briefing focused on event selection, nutritional impact, safety assessment and agronomic data from the GR2E Golden Rice confined field trials in Bangladesh.
Jovic worried for his friend's safety, so harsh were Divac's criticisms of Milosevic, who was later arrested and is now on trial for war crimes.
There is also a lot of information on the internet about baby bedding safety, about trials and testing carried out by independent research groups on certain items, and about possible dangers (including Sudden Infant Death Syndrome) associated with some baby bedding products.
The widespread assumption of safety has led researchers in fetal behaviour to assure women volunteering for clinical trials that ultrasound exposure of one to one - and - a-half hours (sometimes on more than one occasion) is safe for their unborn babies - yet we know of no follow - up of these exposed children.
The motion notes that the Scottish Premier League is planning to initiate trials and calls on the government to recognise «improvements in stadium design and technology mean that, with rigorous safety specifications, standing areas can be safely introduced».
But Ms Kelly maintained the trial on the M4 around Birmingham had shown safety is not compromised by opening the hard shoulder to regular traffic, with the motorway closely monitored by CCTV.
Alleged N2.3 billion NIMASA Scam: Witness says he shared N121 m on Accused's Instruction The Economic and Financial Crimes Commission, EFCC, Tuesday presented the sixth witness in the ongoing trial of a former Director General of Nigerian Maritime Administration and Safety Agency, NIMASA, Patrick Akpobolokemi and five others for the alleged diversion of over Two Billion -LSB-...]
The researchers caution that the booster therapy used in their new study will not be available on the market or even for use in human trials anytime soon; it must await years of animal testing for safety and effectiveness first.
The CO-STAR (Hepatitis C Patients on Opioid Substitution Therapy Antiviral Response) trial sought to evaluate the efficacy and safety of elbasvir - grazoprevir for injection drug users.
Dr. Hemila concludes that given the low cost and safety of vitamin C and the consistency of positive findings in three randomized trials on EIB, it seems reasonable for physically active people to test vitamin C on an individual basis if they have respiratory symptoms such as cough associated with exercise.
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.
The logical substitution was a medication called abraxane, but there were insufficient safety data on combining that with other drugs used in the trial.
The company hopes that early next year it will initiate clinical trials on product safety, which will pave the way for human efficacy testing that could be completed by 2011.
Following additional scrutiny after Vioxx's withdrawal, and the addition of cardiovascular experts to the trial's data safety monitoring board, the DSMB concluded that patients taking a high dose of Celebrex had a 3.4-fold increase in the risk of heart attacks or strokes compared to those on placebo; those on a moderate dose had a 2.5-fold increase in risk.
A second randomized trial on the use of the sun - safety mobile app Solar Cell showed some improvement and was associated with greater sun protection, according to an article published online by JAMA Dermatology.
Biopure Corporation in Cambridge, Mass., is working on FDA approval for its «oxygen therapeutics,» which are intravenously administered to deliver oxygen to the body's tissues, after the agency in July 2005 put the company's clinical trials on hold, citing safety issues.
Rwanda will present safety and efficacy data on 50 patients at the American Urology Association in May 2011, and a randomized, controlled trial with 150 participants, designed to compare PrePex with the conventional surgical method is currently ongoing.
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.
To test the potential benefit and safety of targeted hypothermia in donors on delayed organ function rates in the recipients of their kidneys, Niemann and his research team conducted a randomized controlled trial in two large organ donation service areas from March 2012 to October 2013.
Previous clinical trials have evaluated the efficacy, safety and tolerability of CIP on human patients.
Beattie reported the results of the Edinburgh safety trials at a conference on cancer in Amsterdam last week.
The review focused on U.S. - based trial results on seven approaches used for one or more of five painful conditions — back pain, osteoarthritis, neck pain, fibromyalgia, and severe headaches and migraine — and found promise in the following for safety and effectiveness in treating pain:
In a legal petition delivered to the NIH at the end of June, Jeremy Rifkin's Foundation on Economic Trends, and the Physicians» Committee for Responsible Medicine, threatened legal action if the NIH did not respond within 20 days to their concerns about the safety and ethics of the trials.
Dr. Hemila concludes that «given the safety and low cost of vitamin C, and the consistency of positive findings in the nine randomized trials on vitamin C against exercise - induced bronchoconstriction and respiratory symptoms, it seems reasonable for physically active people to test whether vitamin C is beneficial on an individual basis, if they have documented exercise - induced bronchoconstriction or suffer from respiratory symptoms such as cough or sore throat after taking vigorous exercise.»
The Food and Drug Administration approved the trial in January 2009 but put it on hold last September because of safety concerns after lab animals injected with stem cells developed small cysts at the injury site.
On 31 May, the panel's independent data and safety monitoring board (DSMB) concluded that increased risk of breast cancer caused by hormones had crossed a pre-established line, and it stopped the trial (ScienceNOW, 9 July).
However, the authors stress that «further clinical investigations will be essential to establish the optimal dose, duration and safety, and whether vitamin D2 or D3 have different effects on mortality risk, since the available trials are based on elderly populations in general (an age group with high competing risk of death often due to multiple co-existing disease conditions) and they do not typically include cause - specific deaths as the primary outcomes.»
Two new phase III clinical trials investigating the efficacy and safety of bitopertin, a glycine uptake inhibitor considered to be a promising new add - on therapy for treating negative symptoms in schizophrenia, failed to show a benefit of the drug over placebo.
The drug has already demonstrated safety in nonhuman primate trials, and the cardiovascular research might even be able to skip ahead to a larger phase II trial based on safety data from the ongoing phase I studies, Leeper suggests.
He and his colleagues plan further animal studies of the drug and hope to move on to safety trials in people.
An information sheet for prospective trial participants, posted on a French regional news site, provides an overview of the study's goal and procedures, while also offering a glimpse of what it's like to partake in a lengthy drug safety study.
In 2011 Yale's Open Data Access (YODA) Project reached an agreement with medical device maker Medtronic to act as an intermediary for releasing all data on clinical trials of a controversial bone - growth protein whose safety had been questioned.
By 2007, the drug had been tested on cells and in a phase I clinical safety trial in healthy volunteers.
On a more pragmatic level, the researchers hope to soon be able to translate the findings into clinical trials to test safety and efficacy in people.
If their phase I clinical trial to test the safety and preliminary efficacy of this therapy gains approval, University of Pittsburgh researchers will test the therapy on 10 patients who suffer from chronic ischemic stroke — the most common form, in which clots block blood flow.
But «overall, I wish more attention was paid to the fact that this small trial was to examine safety and efficacy and that much more needs to be done to make statements regarding clinically meaningful impact on disease,» Vandross said.
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.
«With so few patients aged 75 or older enrolled in clinical trials, critical information on the safety and effectiveness of new therapies in this age group is greatly lacking,» she said.
A new paper published in the Journal of Allergy and Clinical Immunology has reported on a multicentre trial to test the safety and clinical efficacy of a new vaccine against grass pollen allergy in patients with grass pollen — induced rhinitis and controlled asthma.
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.
We have commenced a series of clinical trials designed to obtain safety and efficacy data on Epidiolex to provide to the FDA and other regulatory authorities around the world, which is necessary to be considered for approval as a prescription medicine.
The trial mainly tested the safety of the drug in people, and so the final word on whether aducanumab works to ameliorate the memory and cognitive losses associated with Alzheimer's will have to wait until the completion of two larger phase III trials.
Prothena announced the dosing of the first Phase Ia subject on April 8, 2014; they appear to have been successful in recruiting subjects and to have quickly derived favorable safety signals, as they announced the dosing of the first PD volunteer in the Phase Ib trial on July 31, 2014, «based upon safety and tolerability observed to date in the ongoing study in healthy volunteers.»
Impact of Rifabutin or Rifampin on Bedaquiline Safety, Tolerability, and Pharmacokinetics Assessed in a Randomized Clinical Trial with Healthy Adult Volunteers.