He is contemplating a return to medicine, he says, but for now he takes satisfaction in corresponding with addiction researchers from his Paris apartment and encouraging them to conduct
further clinical trials of baclofen.
«If it doesn't show any improvement, then I doubt there will be
any further clinical trials of it.»
Not exact matches
A surge
of call centers opening in India, increasing
clinical trials being conducted in Eastern Europe, and increased manufacturing throughout the
Far East.
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).
If we are required by the FDA, the EMA, or other regulatory authorities to perform studies in addition to those we currently anticipate, or if there are any delays in completing our
clinical trials or the development
of our current product candidates, our expenses could increase and our ability to generate revenue could be
further delayed.
A day after Collins was heard off the House floor discussing the possible sale
of an Australian biotech stock, the company issued a news release
further confirming its experimental treatment for multiple sclerosis had failed in
clinical trials.
WASHINGTON — A day after Rep. Chris Collins was heard off the House floor discussing the possible sale
of an Australian biotech stock, the company issued a news released
further confirming its experimental treatment for multiple sclerosis had failed in
clinical trials.
Researchers have not yet determined which
of these components, or if the combination
of all
of them, may offer protection against inflammation, but Bao and her colleagues are interested in exploring this
further through
clinical trials that would regulate and monitor diet.
But billions
of dollars have poured into large - scale
clinical trials of amyloid - lowering therapies that so
far have failed.
Dr. Del Maestro adds, «Yong and colleagues at the University
of Calgary have begun to unravel the complex interaction
of the microglia with the brain tumor cells, resulting not only in
furthering our understanding, but providing a new concept and drug which can now be immediately assessed in
clinical trials.»
Their results, published this week in the journal Biomedical Optics Express, from The Optical Society (OSA), may yield a cheaper and less invasive initial screening test for colon cancer that could complement colonoscopy, though
further clinical trials will need to demonstrate the safety and effectiveness
of the blood test before it is routinely used.
Thus
far, such side effects seen in
clinical trials have been minor, but it sometimes takes years
of exposure to a drug before deadly infections show up, he says.
«This vaccine appears to be safe for patients, and elicits a broad anti-tumor immunity — we think it warrants
further testing in larger
clinical trials,» said study lead author Janos L. Tanyi, MD, an assistant professor
of obstetrics and gynecology at Penn Medicine.
Previous research has largely focused on dietary components and which diet would be best to lower the risk
of obesity and type 2 diabetes, but so
far there is no clear evidence from epidemiological or
clinical trial data that a specific diet is optimal for long - term weight - loss or lowering the risk
of diabetes.
In collaboration with Ghent University Hospital and Antwerp University Hospital, VIB and Ghent University are now planning
clinical trials to
further validate immunodiagnosis
of FMF.
... The results support the rationale for
further randomized
clinical trials of AHSCT for the treatment
of MS,» the article concludes.
One aspect to the pandemic has, so
far, gone as planned:
clinical trials of the new vaccines.
This small molecule is in
clinical trials against cancer and has high specificity and good pharmacological properties, which could warrant its
further development as antiviral drug for treatment
of pH1N1 virus infection,» Dr. Oxana Denisova says.
These findings provide
further evidence
of ONC201 as an inhibitor
of cancer stem cells and support ongoing
clinical trials in prostate cancer and glioblastoma that have shown evidence
of tumor shrinkage.
The most prominent example so
far is the drug sti571, known as Gleevec, which in a recent
clinical trial put an amazing 53 out
of 54 patients with chronic myelogenous leukemia into remission.
Work done so
far suggests that the technique — a modified form
of IVF — is safe enough to try in
clinical trials, the HFEA panel said, as long as several extra experiments are carried out first and children born as a result
of the technique are followed up for an extensive period.
* GRAIL plans to use the money to
further develop the technology and to run the large
clinical trials (involving hundreds
of thousands
of subjects) needed to see if screening will be feasible.
Despite expectations
of a rapid breakthrough, no cystic fibrosis gene therapy
trial so
far has been able to show long - term
clinical improvement.
«Secondary benefits
of this
trial include the significant improvement in
clinical care for children with sickle cell disease at each
of the 29 sites because each location had a designated hematologist, neurologist, neuroradiologist and psychologist working as a team to identify and decrease
further injury to the brain in this vulnerable population.»
This was the situation for the 14 arm amputees who took part in the first
clinical trial of a new treatment, invented by Chalmers researcher Max Ortiz Catalan, and
further developed with his multidisciplinary team in the past years.
A 38 - center
clinical trial sponsored by the National Institutes
of Health and led by researchers at the Stanford University School
of Medicine has shown that
far more people than previously thought can benefit from an emergency procedure for acute ischemic stroke.
When asked about the ethics
of offering a drug to people who may never get the disease it's designed to prevent, Michael Sand, the Boehringer scientist overseeing the
clinical trial, acknowledges that psychosis risk prediction is
far from perfect.
Further clinical trials are on - going internationally, and we hope to include data from them in a future analysis to determine whether the promise
of today's results is confirmed in an even larger and more diverse group
of patients.»
The study is investigator led and has therefore focused on
clinical need, targeting patients with progressive multiple sclerosis in whom most disability is incurred... The study also reports a predominant effect on neurodegenerative rather than inflammatory outcomes, suggesting a novel mechanism
of action that might be suitable as combination treatment with immunomodulatory treatments...
Further phase 3 studies to measure the effect
of simvastatin on sustained disability, particularly in patients with non-relapsing secondary progressive and primary progressive multiple sclerosis, are clearly needed, but this
trial represents a promising point from which to develop
trials of progressive disease.»
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.»
Watterson and his collaborators have a new National Institutes
of Health (NIH) award to
further refine the compound so it is metabolically stable and safe for use in humans and develop it to the point
of starting a phase 1
clinical trial.
«The team will
further evaluate the long - term biocompatibility
of the modified insulin system in an animal model before determining whether to move to
clinical trials,» says co-author Dr. John Buse, professor of medicine at the UNC School of Medicine and director of the UNC Diabetes Care Center and the NC Translational and Clinical Sciences In
clinical trials,» says co-author Dr. John Buse, professor
of medicine at the UNC School
of Medicine and director
of the UNC Diabetes Care Center and the NC Translational and
Clinical Sciences In
Clinical Sciences Institute.
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.
Looking
further ahead the research will expand to include animal testing and then a series
of clinical trials in humans.
Further study in
clinical trials is necessary, but the study provides a promising new find in a type
of cancer with no current targeted options, Chan said.
In a small phase I and II
clinical trial, Johns Hopkins researchers and colleagues elsewhere found that the high - fat, low - carbohydrate ketogenic diet was a safe and effective treatment option for the majority
of adults experiencing a relatively rare, often fatal and always severe form
of epilepsy marked by prolonged seizures that require medically induced comas to prevent them from
further damaging the body and the brain.
«We can reduce the toxicity
of approved protein drugs, and may also be able to rehabilitate protein fusion drugs that have so
far failed in
clinical trials due to unacceptable side effects.»
«The
clinical trials for treatments have all failed because by the time
of diagnosis the brain is so
far gone that it's like pouring gas into a car that has no engine.»
Dr. Younossi stressed that while these preliminary results are encouraging, he plans to conduct
further research to examine data outside
of the
clinical trial setting in order to evaluate the real - world consequences
of a hepatitis C cure on work productivity and associated economic gains.
Melton and his colleagues are already working with Evotec, a company in Hamburg, Germany, and Janssen Pharmaceuticals, a subsidiary
of Johnson & Johnson, to
further study betatrophin and possibly move it toward
clinical trials.
Scientific knowledge and new findings go
far beyond data sets produced from
clinical trials, often are outside the scope
of the parameters established by the Food and Drug Administration regulations, and often outdate the FDA - approved labeling.»
«Despite the limitations
of a single arm, non-randomized study, we infer from these data that Interferon ß - 1a treatment is worth
further consideration for the treatment
of Ebola virus disease,» said Dr. Fish, who is also a Professor in the Department
of Immunology at the University
of Toronto, noting that the decision to undertake the
clinical trial was based on previous preliminary scientific data, and on the fact that no currently approved antivirals exist to treat Ebola.
Of the five studies the project has tackled so
far, some involving experimental treatments already in
clinical trials, only two could be repeated; one could not, and technical problems stymied the remaining two replication efforts.
Moreover, our previous study found that regular use
of aspirin after diagnosis was associated with longer survival among the 15 % to 30 %
of patients with colorectal cancer and with a mutation in phosphatidylinositol -4,5-bisphosphate 3 - kinase, catalytic subunit alpha (PIK3CA [NCBI Entrez Gene 5290]-RRB-, one
of the PI3K family genes.30 Markedly improved survival associated with aspirin according to PIK3CA status was also found in an analysis within a separate
clinical trial cohort.31
Further investigations for the joint effect
of these genes would be helpful to better understand the underlying molecular mechanisms
of aspirin, NSAIDs, and colorectal cancer.
«This
clinical trial utilizes some
of the best aspects
of what we've learned so
far with chemotherapy and radiation,» says Gregory Gan, MD, PhD.
So
clinical trials are certainly something that are still
far away at the current stage, but it is certainly worthwhile to follow our experimental approach both in vitro and in vivo, in order to test whether at some stage we can really move forward and test, whether by reprogramming endogenous cells, we can reconstitute neural circuits that are damaged or deceased; and, thereby also improve the lives
of many people that suffer neurological diseases.
Of course, we are still far away from being able to do this within the context of a clinical trial in human
Of course, we are still
far away from being able to do this within the context
of a clinical trial in human
of a
clinical trial in humans.
There is no
further news on advancement
of clinical trial although phase I / II
trial has been completed in 2008.
This paper provides direct evidence for the role
of TNF in chronic intestinal inflammation using TNBS colitis in Tg197 mice as a model and encourages
further clinical trials with anti-TNF therapeutics for the treatment
of Crohn's disease.
In an effort to
further exploit the potential
of Pexa - Vec to activate the immune system to fight cancer, as seen in McDonald's preclinical data, SillaJen recently announced a new
clinical trial in collaboration with New York - based Regeneron Inc. to test Pexa - Vec and REGN2810, a PD - 1 checkpoint inhibitor, in combination against renal cell carcinoma, and recently signed a sponsored research agreement with UCSF to enable joint support
of parallel preclinical experiments by McDonald's team.