Not exact matches
In December, Tehrani signed a deal with GlaxoSmithKline that will allow the pharmaceutical giant to test
at least four of its drug candidates
on a Zymeworks - designed platform, which combines a computer simulation with a way of engineering protein molecules and allows products to be refined before they move to expensive
clinical trials.
«Watson is able to give us faster, better matching of patients to potential
clinical trials that our oncologists wouldn't have otherwise be able to see — and I sit with our oncologists who work
on this kind of thing,» Christopher Ross, CIO
at the Mayo Clinic, told MobiHealthNews in an interview.
The striking example I focused
on then was the cancer drug Avastin, developed by Genentech (now Roche)-- which,
at the time, had been studied in
at least 400 completed human
clinical trials for various cancers.
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.
Some retrospective studies and preclinical work have indicated that it might also lower a person's risk of cancer, though
at least one
clinical trial wasn't able to show that it had any protective effect
on esophageal cancer.
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.
Researchers from the Sichuan University in Chengdu inserted the re-engineered cells into a lung cancer patient participating in a
clinical trial at the West China Hospital
on October 28th, according to Nature.
There are about 120 studies ongoing in Israel, including
clinical trials looking
at the effects of cannabis
on autism, epilepsy, psoriasis, and tinnitus.
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).
The Blockchain for
Clinical Trials Forum will take place
on February 12
at the Orlando Science Center in Florida and will bring together prominent healthcare industry stakeholders.
Athenex, which raised $ 68 million from a secondary stock offering during the quarter, finished the year with $ 51 million in cash and short - term investments, down from $ 69 million in September as the company spent heavily
on clinical trials for the drugs it is developing and absorbed higher licensing fees
at its specialty drug business, which has added 12 new drugs to its stable of products.
A March 28, 2018, research note by JMP Securities analyst Michael King indicated that
at the recent International Symposium
on Amyloidosis in Japan, Alnylam Pharmaceuticals Inc. (ALNY: NASDAQ) reported multiple sets of results of
clinical trials, separately evaluating its investigational RNA interference (RNAi) therapeutics patisiran and ALN - TTRsc02.
«There's more emphasis now and there will be more emphasis because of the Affordable Care Act [
on] offering mental health services in primary care settings,» suggests Curry, who is about to start a
clinical trial looking
at the effects of cognitive behavior therapy for adolescents with depression and substance abuse problems.
However, the home atmosphere was described
at trial by a
clinical psychologist as «having taken
on the flavor of an «armed camp.»»
In addition, there was no effect
on breastfeeding duration when the pacifier was introduced
at 1 month of age.280 A more recent systematic review found that the highest level of evidence (ie, from
clinical trials) does not support an adverse relationship between pacifier use and breastfeeding duration or exclusivity.281 The association between shortened duration of breastfeeding and pacifier use in observational studies likely reflects a number of complex factors such as breastfeeding difficulties or intent to wean.281 A large multicenter, randomized controlled
trial of 1021 mothers who were highly motivated to breastfeed were assigned to 2 groups: mothers advised to offer a pacifier after 15 days and mothers advised not to offer a pacifier.
Although some SIDS experts and policy - makers endorse pacifier use recommendations that are similar to those of the AAP, 272,273 concerns about possible deleterious effects of pacifier use have prevented others from making a recommendation for pacifier use as a risk reduction strategy.274 Although several observational studies275, — , 277 have found a correlation between pacifiers and reduced breastfeeding duration, the results of well - designed randomized
clinical trials indicated that pacifiers do not seem to cause shortened breastfeeding duration for term and preterm infants.278, 279 The authors of 1 study reported a small deleterious effect of early pacifier introduction (2 — 5 days after birth)
on exclusive breastfeeding
at 1 month of age and
on overall breastfeeding duration (defined as any breastfeeding), but early pacifier use did not adversely affect exclusive breastfeeding duration.
The Effect of Timing of Cord Clamping
on Neonatal Venous Hematocrit Values and
Clinical Outcome
at Term: A Randomized, Controlled
Trial José M. Ceriani Cernadas, Guillermo Carroli, Liliana Pellegrini, Lucas Otaño, Marina Ferreira, Carolina Ricci, Ofelia Casas, Daniel Giordano and Jaime Lardizábal Pediatrics 2006; 117; 779 - 786; originally published online Mar 27, 2006; DOI: 10.1542 / peds.2005 - 1156 Download file in 380 kb - 10 pages The online version of this article, along with updated information and services, is located
on the World Wide Web
at: http://www.pediatrics.org/cgi/content/full/117/4/e779 Background: The umbilical cord is usually clamped immediately after birth.
Cole is the first Democrat to publicly announce a bid against Collins, whose fifth year in Congress has been marked by controversy over his investment in an Australian biotech company that critics said could have benefited from his work
on a bill aimed
at speeding
clinical trials of new drugs.
Sawyers conducted some of the first, dramatically successful
clinical trials on Gleevec, which inhibits specific enzymes
at play in certain cancers, particularly CML.
Results of the Phase II
clinical trial were presented Feb. 23
at the 2016 Conference
on Retroviruses and Opportunistic Infections (CROI) in Boston.
«It will be very exciting to see if the study can move to a
clinical trial soon,» said Alex Agelidis, a graduate student
at UIC and co-author
on the paper.
Tash, now
at the University of Kansas Medical Center in Kansas City, and colleagues began with an anticancer drug that, during
clinical trials, severely cut down
on sperm production.
Between 2011 and 2014, he conducted three such transplants
at Karolinska University Hospital, four in cooperation with the Kuban State Medical University in Krasnodar, as part of a formal
clinical trial, and one —
on a toddler born without a trachea — in Illinois.
Ophthalmologists
at 10 sites nationwide tested the ring in a phase 2
clinical trial on patients with glaucoma or ocular hypertension.
At the moment, though, he is employed as a full - time clinician at a university hospital — and concurrently works on four research projects, from fundamental science to clinical trial
At the moment, though, he is employed as a full - time clinician
at a university hospital — and concurrently works on four research projects, from fundamental science to clinical trial
at a university hospital — and concurrently works
on four research projects, from fundamental science to
clinical trials.
Findings were presented
at the WCLC are based
on the updated results of 12 lung cancer patients enrolled in the
clinical trial with pembro and irinotecan or gemcitabine with or without vinorelbine or docetaxel.
Although the analysis found pulses had little impact
on «second meal food intake,» the amount of food someone eats
at his or her next meal, these findings support longer term
clinical trials that have shown a weight loss benefit of dietary pulses.
A somewhat obscure study
on statistical methods published in 2009 by medical statistician Ying Lu
at Stanford University, California in a specialty journal
on clinical trials, was downloaded 2000 times in early August, making it the hottest paper among Stanford University's 5439 registered users.
For example, Matt Krause, director of human resources
at CV Therapeutics, says, «Our research programs include multiple, cutting - edge cardiovascular product candidates in various stages of
clinical trials and preclinical programs, all of which rely heavily
on the contributions from our many B.S. - and M.S. - level scientists.»
The team plans to present the results
on 4 November
at the 10th
Clinical Trials on Alzheimer's Disease conference in Boston, Massachusetts.
«We are pleased to have demonstrated such a potent and durable immune response to the vaccine,» said the study's lead author, Sita Awasthi, PhD, a research associate professor of Infectious Diseases
at Penn. «If found effective in
clinical trials, the vaccine will have a huge impact
on reducing the overall prevalence of genital herpes infections and could reduce new HIV infections as well, especially in high - burden regions of sub-Saharan Africa.»
The German biotech CureVac, for example, has brought mRNA - based vaccines for rabies and cancer to
clinical trials, and Karikó now heads a research team
at BioNTech in Mainz, Germany, that focuses
on mRNA - based drugs.
Biden has also been talking to Los Angeles, California, oncologist and billionaire Patrick Soon - Shiong, who
on 11 January announced an industry - led moonshot aimed
at testing in
clinical trials combinations of cancer immunotherapy drugs, one of most promising new cancer treatments in recent years.
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.
Sean Morrison, Professor and Director of the Children's Medical Center Research Institute
at UT Southwestern Medical Center in the United States, who is not an author
on the paper, added: «Patients are ultimately not helped by therapies that are not based
on sound science and that are not tested in systematic
clinical trials.
«The CASTLE - AF
clinical trial represents a landmark in the history of cardiovascular medicine because of its potential impact
on our patients who are suffering from heart failure,» said James Fang, M.D., Chief of Cardiovascular Medicine
at the University of Utah Health.
The GP asked him whether he felt his eczema improved in sunny weather and when the teacher said yes, he was referred to a
clinical researcher
at the local hospital who was starting a
trial into the effects of light
on skin conditions, including eczema.
Researchers, Dr Abi Rose and Dr Andy Jones, from the University's Addiction Research Team conducted a meta - analysis
on all 12
clinical trials comparing baclofen with placebo
on at least one of the described drinking outcomes, craving, anxiety, or depression.
In 1996, when RMP - 7 was first used
on brain cancer patients in a Phase 1
clinical trial at UCLA, it was found to be safe, with virtually no side effects.
The results of this study were first released in late 2016
at the international
Clinical Trials on Alzheimer's Disease meeting in San Diego.
The first - of - its - kind study found the dual treatments to be safe and elicit a
clinical response in patients, according to new results from a phase I
trial to be presented
at the AACR Annual Meeting 2015
on April 19.
The supplement they took has yet to be proved in large
clinical trials, while scientists who have studied it have been caught in the cross fire between converts, willing to take the supplement
on faith and anecdotal evidence alone, and skeptics who look askance
at all alternative medicine.
«Part of what was exciting about the design of this
clinical trial is that we decided early
on to accept women from a younger and generally sicker population than is typically enrolled in
clinical trials,» says Dr. Cristofanilli, who is also a researcher
at the Sidney Kimmel Cancer Center
at Thomas Jefferson University.
The two drug combination «reveals the possibilities of combining an immune signaling molecule with taking the brakes off
at the same time,» said F. Stephen Hodi, MD, first author
on the
clinical trial report.
The study included 124 newly diagnosed patients
at 25
clinical trial sites in the U.S. Two - thirds of the patients were treated with ICT - 107, an experimental vaccine based
on immune system cells called dendritic cells that were exposed to six synthetic proteins, or antigens, known to be involved in GBM development.
Li Ying, a retired chemist
at the Chinese Academy of Sciences Institute of Materia Medica in Shanghai, who worked
on the synthesis of artemisinin derivatives, wrote in an article in 2008 that Tu's method of extraction and purification yielded crystals containing artemisinin mixed with other chemicals, giving rise to toxicity in
clinical trials.
White and colleagues will work with other collaborators
at the Cancer Institute to develop early - phase patient
clinical trials based
on the findings from this study in the near future.
The lab is also working with the Breast Oncology Program
at UCSF to make this data part of an adaptive
clinical trial called I - SPY, which lets researchers identify the most effective therapies based
on patient molecular profiling, and is collaborating with members of the UCSF Institute for Computational Health Sciences (ICHS) to put these and other public data into a centralized database that clinicians can access through an app to help make the most appropriate treatment decisions.
Apart from the loss of time, money and resources, these failures are also «tragic because we have so little
clinical trial information
on children to begin with,» says Florence Bourgeois, an assistant professor of pediatrics and emergency medicine
at Harvard Medical School, who co-authored the study.
It's essential that people feel they are in a safe, comfortable setting with someone who can oversee the experience, says Alicia Danforth, a
clinical psychologist
at the Harbor — UCLA Medical Center in Torrance, California, who is involved in MAPS - sponsored
trials studying MDMA's effects
on social anxiety in adults with autism.