Not exact matches
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.