An advantage of small - molecule PPF — which has been previously
used in clinical trials in an attempt to treat Alzheimer's disease and dementia — is that it can penetrate the blood - brain barrier and reach the tumor.
Not exact matches
Freenome, a liquid biopsy startup that's looking to enter
clinical trials, is working on technology that would be able to detect cancer
in the body, including its location and type,
using only blood samples.
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.
Beginning
in January 2017, IBM employees
in the U.S. will be able to
use Watson supercomputer technology to help find the most effective oncology drugs and
clinical trials for their specific cancers, IBM announced.
The program will involve
clinical trials testing for safety
in humans, followed by a larger
trial using non-human primates exposed to Ebola.
The combo is being
used in phase III
clinical trials.
Besides randomized controlled
clinical trials, there are a number of ways researchers can study how a particular cancer treatment is playing out
in the real world: there are retrospective studies, observational studies, and even prospective research done
using patient registries.
Intarcia has completed several late - stage
clinical trials in which it
uses the pump to deliver a glucose - controlling drug continuously for months — an idea, that if successful (and approved by the FDA) could significantly help patients with type 2 diabetes, fewer than half of whom maintain the recommended glycemic levels.
The biotech plans to shed 20 % of its nearly 600 employees
in order to secure yearly cost - savings of about $ 21 million — money which can then be
used to double down on late - stage
clinical trials for its experimental Parkinson's drug.
Many have
used this data
in designing new methods to supplement and even replace
clinical trials, which are notoriously difficult to fill with patients.
In a
clinical trial of more than 600 participants, Empliciti, when
used with cancer drug Revlimid and steroid dexamethasone was better at delaying when the cancer worsened than just the two drugs alone.
After that,
in perhaps two years, Sharei says, it could be
used in human
clinical cancer
trials.
Deals with pharmaceutical makers to package the Biojector 2000 with specific drugs — including those being
used in clinical trials — give it a clear advantage over some competing devices, says Bioject CEO Jim O'Shea.
Through talking to experts
in the field over the past year, Gates said he had identified five areas of need: Understanding better how Alzheimer's unfolds, detecting and diagnosing it earlier, pursuing multiple approaches to trying to halt the disease, making it easier for people to take part
in clinical trials of potential new medicines, and
using data better.
In fact, one of Marathon's
clinical trials that the FDA
used as part of its decision - making process was conducted more than 20 years ago, saving the firm plenty of study costs.
Brendan Kennedy, the cofounder of Privateer Holdings, which owns various marijuana companies like Marley Natural and Canadian pharmaceutical - grade cannabis producer Tilray, explains how Tilray is already exporting marijuana to countries like Croatia and Australia for
use in clinical trials.
«Stakeholder interest
in the initiative and the upcoming IEEE Blockchain for
Clinical Trials Forum is strong, and we encourage even broader participation and input from vested healthcare and regulatory partners
in order to identify pertinent issues and more viable
use cases that can help us advance industry - wide adoption,» said Tim Mackey, co-chair of the IEEE - Standards Association Supply Chain /
Clinical Trials Industry Connections Program.
We do this by conducting
clinical trials in which we collect safety and efficacy data about our experimental drugs with the goal of submitting those data to regulatory authorities, like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), so that these experimental drugs can be approved for
use by patients.
Cambridge, MA — March 30, 2017 — Aura Biosciences, a biotechnology company developing a new class of therapies to target and selectively destroy cancer cells
using viral nanoparticle conjugates, announced today that it has enrolled and dosed the first patient
in its Phase 1b
clinical trial of light - activated AU - 011, an investigational, first -
in - class targeted therapy
in development for the treatment of ocular melanoma, a rare and life - threatening disease.
To achieve this goal, several approaches are envisaged: identifying small populations with severe disease where a medicine's benefit - risk balance could be favorable; making more
use of real - world data where appropriate to support
clinical trial data; and involving health technology assessment bodies early
in development to increase the chance that medicines will be recommended for payment and ultimately covered by national healthcare systems.
And the San Francisco Chronicle reports that over 100
clinical trials listed on the ClinicalTrials.gov website feature Fitbit trackers
in addition to those
trials using the Apple Watch, Jawbone, Garmin, Pebble and other devices.
But topping the list is Vertex (VRTX), which has a veritable plethora of HCV drugs
in late - stage
clinical trials, which are
used either alone, or
in combination with other drugs.
However a lesser known berry — the gooseberry — has now been
used in clinical trials to prove its reduction
in cardiovascular diseases.
«We chose to
use Axiom Foods» Oryzatein ® ingredient,» said CEO of Growing Naturals, David Janow, «because it is the only 90 % brown rice protein isolate that is made with a proprietary enzyme fractioning method and was shown
in a
clinical trial for the first time to equal animal - based whey protein
in building and maintaining muscle.»
(Culver City, CA August 27, 2013)-- After Oryzatein ® was recognized as the first plant - based rice protein to equal animal - based whey protein for muscle building and repair
in a
clinical trial published last month, an «Oryzatein ® Inside» endicia is being provided to manufacturers who
use the ingredient
in their food products.
Throughout 2017, ongoing
clinical trials in regenerative medicine
using cord blood have offered hope to families facing life - changing medical conditions, such as cerebral palsy and autism.1 For some of these families, banking their baby's cord blood with ViaCord gave them the opportunity to participate
in this groundbreaking research.
We searched ClinicalTrials.gov (30 June 2016) and the WHO International
Clinical Trials Registry Platform (ICTRP)(1 July 2016) for unpublished, planned and ongoing
trial reports
using the terms given
in Appendix 1.
Now that they've demonstrated the significance of insulin signaling
in the human mammary gland, they are planning a phase I / II
clinical trial with a drug
used to control blood sugar
in type 2 diabetes to determine whether it improves insulin action
in the mammary gland, thus improving milk supply.
Cord blood stem cells can be
used to treat dozens of diseases and are being tested
in FDA - regulated
clinical trials to help people with autism, brain injury, and other conditions.
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 pacifie
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 pacifie
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.
The safety of the vaccine has been established
in large
clinical trials and will be continually monitored as it comes into wider
use,» Ed Yong, health information manager at the charity told politics.co.uk
In 2002, Home Secretary David Blunkett announced that he might permit the medical
use of cannabis if
clinical trials of the drug were successful.
While they were able to block DOT1L directly
using an inhibitor substance currently being tested
in a
clinical trial for a different type of leukemia, a direct drug - based inhibition of MLL proved impossible.
Walking through the latest research and
clinical trials seeking to restore the mobility, communications and muscle
use of soldiers was Dr. Leigh Hochberg, a neurologist and engineer
in neurotechnology at Massachusetts General Hospital and a director of the Veterans Affairs Medical Center
in Providence, Rhode Island.
«The next step is to carry out
clinical trials to test if this treatment combination is safe to
use in patients and if it helps more men survive the disease.»
To
use genomics resources to benefit patients, consider research hospitals that do
clinical trials, he advises; to turn discoveries into diagnostic tools and medicines, look for opportunities
in the life science industry.
It also says that there have been no formal
clinical trials of the procedure but that OvaScience are planning to carry out 1000 rounds of IVF around the world this year
using Augment, partly to convince the US Food and Drug Administration to approve the treatment
in the US.
The team hopes to begin
clinical trials in 2017, but this depends on getting permission to
use lab - made sperm to fertilise a human egg.
«Thus, we hope that its potential as a powerful therapeutic agent for the treatment of autoimmune diseases will facilitate its
use in future
clinical trials.»
«If you don't
use as close to the total physiological system that you can, you're likely to run into troubles,» like being surprised by side effects later on
in clinical trials, says William Haseltine, founder and former chairman and CEO of Rockville, Md. — based Human Genome Sciences.
The results, published online
in the journal Brain, Behavior and Immunity, strengthen the case that transgenic Huntington's disease monkeys could be
used to evaluate emerging treatments (such as this) before launching human
clinical trials.
He now is a co-investigator
in the first randomized
clinical trial comparing proton therapy with more conventional radiation — something he acknowledges should have happened before so much
use.
AAV is
in use in many late - stage
clinical trials in the United States, and has already been approved for
use in one gene therapy drug
in the European Union.
«Most of our samples are consented — that is, the patient is
in a
clinical trial or has consented to have the sample
used in a
clinical trial,» Bry says.
In an effort to find out, Stephen P. Juraschek, M.D., Ph.D., research and clinical fellow in general internal medicine at the Johns Hopkins University School of Medicine, and his colleagues used data from the DASH (Dietary Approaches to Stop Hypertension) clinical trial, a widely popular and often - cited study whose results were first published in 199
In an effort to find out, Stephen P. Juraschek, M.D., Ph.D., research and
clinical fellow
in general internal medicine at the Johns Hopkins University School of Medicine, and his colleagues used data from the DASH (Dietary Approaches to Stop Hypertension) clinical trial, a widely popular and often - cited study whose results were first published in 199
in general internal medicine at the Johns Hopkins University School of Medicine, and his colleagues
used data from the DASH (Dietary Approaches to Stop Hypertension)
clinical trial, a widely popular and often - cited study whose results were first published
in 199
in 1997.
«The good news is that drug companies are
using our skin biopsy technique
in ongoing
clinical trials to monitor treatment success.»
Now a University of Colorado Cancer Center study published online ahead of print
in the journal Oncogene offers compelling evidence explaining this failure and offering a possible strategy for the
use of retinoic acid or other retinoids against some breast cancers: Because early
clinical trials are often offered to patients who have already tried other more established therapies, breast cancer cells may have been pushed past an important tipping point that offers retinoic acid resistance.
He notes his company had planned this year to apply to the U.S. Food and Drug Administration to
use red blood cells and platelets derived from iPS cells
in clinical trials, but «at this point, therapies with these cells are years off.»
Dr. Siddiqui plans to
use MRI / ultrasound fusion
in a
clinical trial to identify and biopsy questionable areas within the prostate.
In this new study and for the first time, scientists used functional magnetic resonance imaging (fMRI) combined with a standard clinical trial design to derive an unbiased brain - based neurological marker to predict analgesia associated with placebo treatment in patients with chronic knee osteoarthritis pai
In this new study and for the first time, scientists
used functional magnetic resonance imaging (fMRI) combined with a standard
clinical trial design to derive an unbiased brain - based neurological marker to predict analgesia associated with placebo treatment
in patients with chronic knee osteoarthritis pai
in patients with chronic knee osteoarthritis pain.