It also alludes to the complex phenotypes and rare
drug outcomes resulting from rare pharmacogenomic variants.
Not exact matches
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.
The Grocery Manufacturers Association (GMA) last week urged the Food and
Drug Administration to ensure any proposed long - term sodium reduction targets are based on a review of the Dietary Reference Intake (DRI) for sodium, future knowledge gained from work on the short - term sodium reduction targets,
results of new research that will become available on human health
outcomes and dietary sodium intake, and the emergence of new technologies that allows sodium reduction targets to be safely and effectively achieved.
After the positive
results from a random
drug test, she was pulled from her security post at Gracie Mansion and remains on paid desk duty in Queens pending the
outcome of the trial.
He further stated that the
outcome of the
result would assist him to move a motion in the Senate that public officers and their appointees should be undergoing psychiatric and
drug related tests from time to time.
«We had thought that previous trials may have been limited by their use of first - generation
drug - eluting stents, but these
results show CABG still leads to better
outcomes.»
«When we heard that patient
outcomes are held back by fear of hypoglycemia (low blood sugar), we created
drugs that
result in a reduced risk of hypoglycemia,» he says.
As a
result of a 2007 law, within 1 year of the completion of a trial,
drug companies must also submit summary
results that include information such as the number of participants, their age and gender,
outcomes, and adverse events.
The
drug — named mepolizumab — can replace traditional, steroid - based treatments for a specific subset of patients,
resulting in improved
outcomes and reduced side effects.
When
outcomes from these two groups were added together, the absence of any benefit from
drug therapy in patients with an unwitnessed arrest may have muted the significant benefit seen in those with a witnessed cardiac arrest,
resulting in the marginal overall
outcome of the study.»
In addition, patients with bovine TB often do not respond to the
drugs commonly used to treat TB, sometimes
resulting in a fatal
outcome.
«The lack of association between response rates and hard clinical
outcomes raises concerns about fast track approval of new
drugs, based on
results from trials utilizing solely these surrogate markers,» the researchers wrote.
This can occur due to a lack of consideration of the disease process, inadequate use of diagnostic testing, client pressures or the perceived need to «do something» — the perception that if veterinarians don't use antibiotics and a bad
outcome results, it's the practitioner's fault, but the
drug is at fault if a complication from antibiotics develops, Weese added.
The
results of this study also make it clear that the negative effects of break - up can extend beyond simply feeling sad or lonely, and can coincide with much more potentially serious
outcomes, especially when you consider the serious consequences associated with criminal behavior, drinking, and
drug use.
This could be an artifact caused by premature mortality in people with multiple adverse childhood exposures; the clustering of multiple risk factors among people with multiple childhood exposures is consistent with this hypothesis.29 Thus, this potential weakness may have
resulted in underestimates of the true relationships between ACEs and the illicit
drug use
outcomes.41
It found that diversion treatment programs for offenders with
drug and alcohol problems save money and
result in better health
outcomes and lower recidivism rates.
Results demonstrated significantly better
outcomes than those who received treatment - as - usual on trauma related symptoms, although not on alcohol or
drug use.
Adolescent FBT's goal is to
result in positive
outcomes in such areas as alcohol and
drug use, depression, conduct problems, family dysfunction, and days absent from work / school.