The results of the study, which is funded, in part, by a grant from Bone Cancer Dogs Inc., will build a foundation
for further clinical trials.
Not exact matches
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).
* MEDICINES360 AND ALLERGAN PRESENT 5 - YEAR
TRIAL DATA FROM LARGEST ON - GOING IUS
CLINICAL STUDY Source text
for Eikon:
Further company coverage:
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.
The compound, already proven safe
for humans, is undergoing
further animal testing in preparation
for possible
clinical trials in cocaine addicts, the researchers say.
«Our results indicate it is a promising agent
for clinical trials, and a as an add - on to more conventional therapies, to prevent tumour recurrence,
further disease progression and metastasis.»
The evidence presented
further suggests that IL - 17 is necessary only
for the initial sensitization to allergen and may therefore explain the recent finding that an IL - 17RA antibody was unable to affect established asthma symptoms in a recent
clinical trial.»
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.
Dr. Ianchulev expects additional
clinical trials to begin within the next 12 months to
further evaluate the technology
for treating patients with glaucoma, as well as
for pupil dilation.
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.
«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.
«
For patients diagnosed with MGUS, maintaining a healthy weight may be a way to prevent the progression to multiple myeloma, if
further confirmed by
clinical trials.»
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.
... The results support the rationale
for further randomized
clinical trials of AHSCT
for the treatment of MS,» the article concludes.
According to CenterWatch, an online
clinical trials listing service that publishes the manual, approximately 20,000 copies have been sold so
far: The sales were «beyond what we expected,» reveals Chadwick, underscoring the fact that there is huge demand
for such materials.
Pediatricians in community practice may not have enough time to participate in
clinical research, especially if they work
far from academic hospitals where supportive resources
for clinical trials are readily available.
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.
Thus, so
far, it has never been investigated whether individuals in
clinical trials experiencing side effects from antidepressant medication, and
for this reason may have guessed that they have not received placebo, also respond more favorably to treatment than those without side effects.
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.
The U-M team has new NIH funding
for an additional
clinical trial to
further refine the approach.
«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.
It has disbursed $ 671 million so
far, mostly
for basic research and
clinical trials.
Further research will be needed to adapt the technique
for humans, but the approach could offer improved safety and efficacy control
for human
clinical trials, which are now underway in Canada.
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.
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.
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.
«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.»
«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.
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.
For further information about PNP's
clinical trials, please visit clinicaltrials.gov or call Lisa Clemons, R.N., at 205-934-9713.
For further information on
clinical trials, visit Trialnet @ www.diabetestrialnet.org/index.htm and / or the Juvenile Diabetes Research Foundation website @ www.jdrf.org /.
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.
Testing these structural and functional markers in glaucoma suspects and patients and importantly, in patients enrolled in
clinical trials for vision restoration, which I know are few and
far between.
Following the success of
trials showing that the Cytosponge was as good a diagnostic tool as endoscopy, and
far more pleasant
for patients, Rebecca's team has received funding
for a 4,000 - patient
clinical trial to pave the way
for the Cytosponge to become the first - line assessment
for Barrett's oesophagus.
Current stem cell therapies have been the standard of care
for many cancers, blood and immune disorders and it is anticipated that new therapies will be
further available as the results of thousands of
clinical trials are reported.
So
far, JQ1 has been relatively well tolerated in both preclinical studies and in early phase
clinical trials for cancer patients.
The authors concluded that these meta - analyses support the need
for further controlled, larger
trials to assess the
clinical efficacy of rTMS on negative and positive symptoms of schizophrenia, while suggesting the need
for exploration
for alternative stimulation protocols.
Tests developed under design control and manufactured under cGMP stratify patients in a
far more reproducible way, being critical to optimize treatment and select patients
for clinical trials.
Partial
clinical hold on high dose SGT - 001 resolved, additional information requested on full
clinical hold NIH grant will
further development of replacement beta cells
for type 1 and type 2 diabetes New
trial will assess MSCs to improve heart function in heart failure patients ReNeuron wins grant
for retinal cell therapy development
clinical trial early
for ethical reasons when they saw that the overall cure rate of 94 percent with donor feces had
far outpaced the 31 percent cured with the antibiotic vancomycin.
To deliver the first treatments
for CMT, we need funding
for clinical trials and
further drug development.
To deliver the first treatments
for CMT1A and other types of CMT, we need funding
for clinical trials and
further drug development.
To
further develop genetically directed early phase
clinical trials — in part through Center for Cancer Targeted Therapeutics (C2T2), Early Cancer Therapeutics Consortium (ECTC), National Clinical Trials Network (NCTN) with Molecular Analysis for Therapy Choice
clinical trials — in part through Center for Cancer Targeted Therapeutics (C2T2), Early Cancer Therapeutics Consortium (ECTC), National Clinical Trials Network (NCTN) with Molecular Analysis for Therapy Choice (M
trials — in part through Center
for Cancer Targeted Therapeutics (C2T2), Early Cancer Therapeutics Consortium (ECTC), National
Clinical Trials Network (NCTN) with Molecular Analysis for Therapy Choice
Clinical Trials Network (NCTN) with Molecular Analysis for Therapy Choice (M
Trials Network (NCTN) with Molecular Analysis
for Therapy Choice (MATCH).
Researchers responsible
for both regimens will study them
further in rigorous
clinical trials being launched this year.
Evidence from
clinical studies so
far, including evidence from the well - known Ornish
clinical trials, tells us that vegetarian diets can reduce risk factors
for heart disease and improve the health of the heart — however, the diets tested were not only meatless, they were also very low in fat and very low in refined carbohydrates.
The single - blind, randomized
clinical trial was published online at the end of February in the New England Journal of Medicine.3 It is perhaps one of the strongest validations of my optimized Nutritional Plan so
far, which calls
for high amounts of healthful raw fats, including omega - 3, modest high - quality animal protein, and restriction of carbohydrates to high - fiber vegetables — all from fresh whole foods, as opposed to processed.
Goodman tells that several years later a large
clinical trial comparing the treatments found the course he chose
for treatment
far outperformed the one his first oncologist would have had him on.