Sentences with phrase «other clinical trials with»

Not exact matches

Then, they plan to get started with clinical trials in their journey toward FDA approval, starting with peanuts, but expanding out to the other top food allergies, such as soy, wheat, milk, and eggs.

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.

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.

By printing multiple lung airways — or any other afflicted organ — from a human patient and testing drugs on them, pharma companies can bypass the ethically challenged practice of testing on animals and proceed to human clinical trials with greater confidence the drugs will actually work, according to Wadsworth.

GUMC says its researchers are now planning larger clinical trials with nilotinib for patients with Parkinson's and other similar diseases including Alzheimer's disease, likely to begin in 2016.

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 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.

He contributes to other large - scale clinical trials including SAVE (evaluating whether treatment of obstructive sleep apnoea with continuous positive airways pressure can reduce the incidence of serious CV events in patients with established CVD), and CREDENCE, a randomised, double - blind, placebo - controlled trial assessing whether canagliflozin can slow the progression of diabetic nephropathy in patients with type 2 diabetes.

A couple of people talked about clinical trials (those that I talked about above), and Melissa (FAAN Teen Advisory Group member) talked about living with Multiple Food Allergies and other Auto - Immune Disorders.

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.

The meta - analysis looked at 21 clinical trials involving 940 adult men and women, who lost an average of 0.34 kg (0.75 pounds) over six weeks with the addition of a single serving of pulses to the diet — and without making a particular effort to reduce other foods.

Nusinersen, approved by the U.S. Food and Drug Administration in December 2016, became the first drug approved to treat spinal muscular atrophy, with several other experimental drugs still in clinical trials.

Other reasons for testing tau drugs in PSP patients have more to do with clinical trial practicalities.

That means attending meetings, planning clinical trials, coordinating research, and communicating with other units within the company including technicians, statisticians, and also marketing people.

«Every day, most of us take for granted that when we will to move, we can move any part of our body with precision and control in multiple directions and those with traumatic spinal cord injury or any other form of paralysis can not,» said Benjamin Walter, associate professor of Neurology at Case Western Reserve School of Medicine, Clinical PI of the Cleveland BrainGate2 trial and medical director of the Deep Brain Stimulation Program at UH Cleveland Medical Center.

In 2012, the NHMRC provided almost A$ 3 million in research funding for clinical trials for people with chronic diseases, among many other projects.

«There are multiple clinical trials going on right now with other members of the thiopeptide class.»

Roche has four biologic cancer immunotherapy molecules in clinical trials that could work in powerful combinations with each other or with current drugs, says William Pao, global head of oncology discovery in Basel.

It's kind of heartbreaking to hear these extraordinary innovators pick apart each other's work as they race to finish their various devices, complete clinical trials big enough to gain FDA approval and ramp up production with sufficient support personnel to help diabetics actually strap one on by 2017 or 2018.

Another problem is that modeling studies, like this one, are inherently less powerful than other kinds of medical research: randomized clinical trials, the gold standard in medical research, in which patients are randomly assigned different treatments or no treatment; case - control studies, which compare patients who have a condition with those who do not; or cohort studies, which determine the risk of contracting a disease by studying a group of people with similar demographics.

Many clinical trials combine virotherapy with chemotherapy or other immunosuppressive agents to try to allow the virus to survive and infect as many cancer cells as possible.

Dr. Criner said that despite the clinical trial's finding that the statin drug did not help with COPD flare - ups, information gleaned from this study should help inform other research into the inflammatory nature of COPD.

More than 500 clinical trials are underway to explore the impact of these and other checkpoint inhibitors on a dozen varieties of cancer, alone or with other immunotherapies, as well as conventional treatments.

While other randomized clinical trials have evaluated the effects of varying weight loss in people with obesity, this is thought to be the first time a trial has separated weight loss outcomes in people who achieved a 5 percent weight loss from those who achieved a 10 percent or greater weight loss.

The immunotherapy drug pembrolizumab — already FDA - approved for other forms of cancer - has been found to be effective in patients with metastatic triple negative breast cancer, according to an international clinical trial led by NYU Langone's Perlmutter Cancer Center.

The phase 2 randomized clinical trial was conducted by the Eastern Cooperative Oncology Group, enrolling 245 patients with stage 3 or stage 4 metastatic melanoma who had been treated with other drugs.

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.

In its first clinical trial, a breakthrough antibody therapy produced at least partial remissions in a third of patients with multiple myeloma who had exhausted multiple prior treatments, investigators at Dana - Farber Cancer Institute and other organizations report today online in the New England Journal of Medicine.

More recently, HCQ has shown promise in treating pancreatic cancer patients in ongoing clinical trials; however, its tolerability and effectiveness to stop autophagy in humans with other cancers has not been shown before.

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.

Long - term use of mifepristone has been studied in clinical trials for other tumors, with minimal adverse effects reported after years of usage.

To confirm these results, the next step will be to establish a clinical trial with patients suffering motor skills disorders due to a stroke and divide them into two groups: one of them undergoing physiotherapy treatment and the other with complementary cognitive training.

«And then proximity to other resources like hospitals,» which can collaborate with companies on research, such as with clinical trials.

«The research lays the groundwork for possible clinical trials to address the behavioral aspects of anorexia nervosa and other neuropsychiatric diseases with compulsive behavioral components,» he said.

The impetus for the plan is evidence from recent clinical trials showing that treating people with HIV earlier not only reduces the likelihood of disease progression but also lowers the chances that they will infect others.

Studies are underway, and similar to the glioma therapy development, I am working to develop clinical trials for brain metastasis, together with medical oncologists Mansoor Saleh, M.D., Andres Forero, M.D., and others at UAB.»

The therapy was found to have an acceptable safety profile in all patients, with no clinical or laboratory signs of systemic cytokine release syndrome, a potentially serious toxicity that has been observed in other CAR trials.

In clinical trials, MannKind's treatment has not given rise to the weight gain often seen with other insulin therapies, perhaps because diabetics do not need to snack between meals to avoid hypoglycemia, Richardson says.

Vaccine developers are trying to improve vaccines for transplant recipients and other people with a weak immune system, and the samples used in this study came from a clinical trial of different versions of a flu vaccine in patients on immune - suppressive drugs.

But clinical trials of such a drug, Pfizer's Torcetrapib, were halted in 2006 when investigators discovered that it was associated with an increased risk of death from heart attack and other complications, including cancers and infections.

Before now, researchers wanting to find out whether disease genes could be targeted with drugs had to search piecemeal through scientific literature, clinical trials databases or other sources of information, some of which were not publicly available or easily searchable.

In December 2009, Summers became the first patient enrolled in a clinical trial of a method pioneered in studies with rodents and cats by Edgerton and others.

With Wartman's GVHD in a holding pattern, he keeps searching for other drugs to try off - label or in clinical trials.

Ongoing clinical trials with 20 other so - called direct - acting antivirals have had even more impressive results against HCV, and researchers have high hopes that curing this devastating disease will become routine — but only if people know they are infected and seek treatment.

The authors identified 35 clinical trials: 23 compared ACEIs with placebo or other active drugs (n = 32,827 patients) and 13 other trials compared ARBs with no therapy (controls)(n = 23,867 patients).

Our results suggest the need for future studies involving long - term ambulatory cardiac monitoring to better delineate the risk associated with transient vs persistent perioperative AF, as well as randomized clinical trials to determine optimal strategies for antithrombotic therapy in patients with perioperative AF and a significant burden of other risk factors for stroke,» the authors write.

To search for other characteristics of ccRCC tumors that influences immunotherapy response or resistance, the researchers used whole - exome DNA sequencing to analyze tumor samples from 35 patients treated in a clinical trial with the checkpoint blocker nivolumab (Opdivo).

Then they'd have to conduct clinical trials to prove zinc chelation in the retina is safe and effective in people with other conditions, such as glaucoma.

Boehm said that a clinical trial for a drug to treat the sisters and others with ACDC is currently under review by an ethics board.