Sentences with phrase «of failed clinical trials»

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In particular, the complaint alleges that throughout the Class Period, defendants made materially false and / or misleading statements and / or failed to disclose that (1) the trials for GED - 0301 suffered from fatal design defects, such that GED - 0301 had failed to demonstrate meaningful clinical efficacy; (2) the growth of Otezla sales had dramatically slowed during Celgene's third fiscal quarter of 2017; and (3) the clinical and nonclinical pharmacology data in Celgene's new drug application («NDA») for Ozanimod were insufficient to permit a complete review by the FDA, which resulted in the FDA issuing a refusal to file letter to Celgene regarding the NDA.
But while thousands of clinical trials on immunotherapy drugs, of which many are predicted to fail, are springing up, the depth of information on neoantigen vaccines is much shallower: Just two studies on neoantigen vaccines for melanoma, recently profiled in Nature, were completed last year in Boston and Germany.
But a late - stage clinical trial called CheckMate - 026 for the drug failed to meet its primary goal of halting cancer progression in advanced, untreated patients whose tumors consisted of at least 5 % PD - L1.
That also could bring new life to pancreatic cancer drugs that have failed in clinical trials because they were unacceptably toxic to the rest of the body, she says.
On average about 99 % of all drugs in clinical trials never actually make it to approval, and drugs are still failing late - stage trials in 2017.
Solanezumab, a drug developed by Eli Lilly that also acts on the amyloid hypothesis, failed some key clinical trials, though the company is still testing it in the pre-clinical stages of the disease.
Shares of biotech Sage Therapeutics slumped 15 % in Tuesday afternoon trading after the company's experimental seizure disorder treatment, brexanolone, failed to meet the key goal in a clinical trial.
The flagship drug of San Diego's MediciNova failed a midstage clinical trial for methamphetamine dependency, casting doubt on prospects for a product it has placed great hopes in.
Cases brought against producers of legal highs could fail due to the absence of any clinical trials on humans, MPs heard.
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.
The value of Innate's shares tanked in late - June following a failed clinical trial for its multiple sclerosis treatment.
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 value of stock in a multiple sclerosis drug company - which includes large holdings by members of Congress - collapsed Tuesday when company officials announced the drug failed during recent clinical trials.
But billions of dollars have poured into large - scale clinical trials of amyloid - lowering therapies that so far have failed.
Until now sepsis has been treated as an inflammatory disease but more than 30 clinical trials of anti-inflammatory drugs for sepsis have failed.
Currently, 92 per cent of new drugs fail clinical trials, even though they have successfully passed animal tests.
Clinical trials testing various cancer vaccines have failed miserably; in one, a melanoma vaccine called Canvaxin did not improve the survival of patients, an outcome that ultimately forced the drugmaker to sell itself to another firm.
Northfield Laboratories, Inc., in Evanston, Ill., has been conducting clinical trials for its oxygen - carrying red blood cell substitute, PolyHeme, but in May said the product failed to meet the primary goals of mortality and safety in an important phase III study.
Several vaccines against HSV - 1 tested in clinical trials for the prevention of adult - to - adult transmission have failed, Leib noted, but none have been tested for prevention of adult - to - baby so - called «vertical transmission» of the virus.
Many of the clinical trials carried out to date with with synthetic cannabis have failed, with no measurable effect being recorded in patients.
During a conversation this month in his office at Weill Cornell Medicine in New York City, Fine rattled off more dismal stats, like the many failed clinical trials of experimental drugs for glioblastoma; like the paltry increase in life expectancy for people with glioblastoma from 12 months in 1990 to 15 today; like the stupid (in hindsight) assumptions about how glioblastomas grow and how to study them in mice.
Michos notes that a recent randomized clinical trial published in JAMA Cardiology failed to show any cardiovascular benefit with high - doses of monthly vitamin D supplements among participants living in New Zealand.
And up to half of participants enrolled in clinical trials to treat PTSD fail to respond to therapies including serotonin - reuptake inhibitors — a class of drugs often used as antidepressants — and cognitive behavioural therapy.
But the most promising candidates — compounds called vaginal microbicides that thwart the virus at the site of infection — have failed repeatedly in clinical trials.
But the results of the clinical trial, first presented at a meeting a year ago, showed that the vaccine failed to raise an adequate CD8 + response, and it protected only two people.
A new type of pump to help failing hearts will undergo clinical trials in autumn 2004 in the UK.
Two new phase III clinical trials investigating the efficacy and safety of bitopertin, a glycine uptake inhibitor considered to be a promising new add - on therapy for treating negative symptoms in schizophrenia, failed to show a benefit of the drug over placebo.
Despite the urgent need, almost all clinical trials of neuroprotective therapies to date have failed to translate from the laboratory to the clinic, according to the RBC research team.
«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.»
While the use of antiangiogenesis drugs that block the growth of new blood vessels can improve the treatment of some cancers, clinical trials of their ability to prevent the development of new metastases have failed.
While the last decade has seen many potential new agents for hepatocellular carcinoma fail in clinical trials, phase I and II data from early regorafenib trials were promising, and led to the initiation of this international, multi-center phase III trial.
«The problem in the cancer field is that they have many high - profile papers of clinical trials [that] all failed in some way,» he said.
Activists often slam large pharmaceutical companies for failing to develop drugs that are of critical importance to the developing world.Andrew Witty, GlaxoSmithKline's youthful chief executive, gave those critics pause yesterday in a speech to the Council on Foreign Relations in New York City.Witty promised to sell the company's malaria vaccine that is in late - stage clinical trials in Africa for no more than a 5 percent profit.
This spring, a clinical trial will start at the Alberta Children's Hospital exploring the clinical efficacy of vorinostat in children who have failed to respond to current anti-seizure medications.
However, drugs that structurally resemble the TPO hormone can be problematic; about 12 years ago a lab - grown, «recombinant» version of TPO failed in clinical trials when it was found to induce a deleterious anti-TPO antibody response.
Concerningly, 20 % of publicly funded cancer clinical trials in the United States fail because investigators are unable to enroll enough participants.
Having undertaken a one year internship at CSL Biotherapies in the final year of my undergraduate degree, I realised that many new drugs had the propensity to fail when moving from initial discovery into clinical trials.
Some other gene products for treatment of CLI have failed in the late phases of clinical trials (for example,
When treatment begins to fail, University of Chicago medical oncologists with expertise in GIST can offer treatment with multiple novel agents, including sunitinib or investigational drugs available only through clinical trials.
Some other gene products for treatment of CLI have failed in the late phases of clinical trials (for example, Sanofi's FGF - based gene product).
PI3K inhibitors are the subject of some 100 clinical trials, including one that will test whether a cancer treatment's early failure to reduce glucose uptake, as measured by FDG PET, can predict whether the therapy will fail to shrink a patient's tumor.
When tested on people in the context of a rigorous clinical trial, many possible new treatments fail to be proven safe and effective.
But all of these studies, including more than 25 phase II and III clinical trials, have failed to offer significant benefit to patients.
Much of the research effort to find new drugs to treat this disease has focused on the senile plaques, but so far these drugs have all failed in late - stage clinical trials.
One intriguing idea is that scientists could revisit samples from past clinical trials to build a larger picture of the relationship between NfL and HD progression, and to determine whether experimental treatments lowered NfL, even if they failed to improve symptoms.
And don't they realize that even if a clinical trial fails to demonstrate that a drug or surgery or alternative medicine treatment is better than a placebo, that doesn't mean it doesn't «work» when 18 to 80 % of the time, the body heals itself when given a sugar pill or saline injection in a clinical trial.
(1) The dramatic failure of Alzheimer's clinical trials is due to the medical community's approach to research, which is primarily focused on developing a «miracle drug» for AD and fails to take into account the multitude of factors that contribute to this complex chronic illness.
Recent attempts on extensive trials of cancer vaccines, using viral structures or substructures against several cancers such as cervices, prostate, lung, pancreatic and skin also failed to produce the overall protective clinical outcomes
«One of the more vexing problems bedeviling Alzheimer's research is why so many treatments that are successful in mouse models fail in clinical trials with humans.
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