«These new findings will have important implications for
drug design by clearly defining exactly how these signals become integrated, so we will be able to predict how changes in a drug's design could affect signaling.»
The specific
drugs designed by WAVE have been tested in cells in a petri dish, where they successfully lowered the mutant protein whilst leaving the normal version relatively untouched.
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.
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.
What Boger wants is to create a better way to develop
drugs: through a process called structure - based
design in which scientists build up a new
drug, atom
by atom, after determining the type of molecule that might interrupt the disease process.
Late last week, the Food and
Drug Administration gave its stamp of approval to the marketing of the world's first device
designed to help diagnose ADHD — a disorder that plagues some 6.4 million children —
by scanning a child's brain waves.
We need to
design clinical trials and outcomes in a way that captures the downsides of aging in a quantitative way» that allows targets for
drug approvals
by the FDA.
That cash doesn't include the money PhRMA's spending on the ongoing «Go Boldly» campaign, a series of TV, print and radio ads
designed to polish the
drug industry's image
by reminding the public that
drug companies do world - class research that brings disease cures to market to save lives.
The conscience you try and drown out with alcohol,
drugs, and sarcastic comments... Well it turns out that conscience of yours was
designed by God to wake you up out of your foolishness.
In June 2016, the Food and
Drug Administration (FDA) announced draft voluntary sodium reduction targets, which were partly informed
by the
design of the National Salt Reduction Initiative.
This program is
designed to target and shut down known
drug markets
by establishing programs through which police can collaborate with both prosecutors and the general public.
Officers in all but five police departments in Erie County carry naloxone, known
by the brand name Narcan, a rescue nasal spray
designed to revive users who overdose on opioid
drugs.
Drugs designed to cut the risk of heart disease are being talked down amid a worrying lack of use
by people who could benefit from them, says Anthony Warner
One of those licenses went to Michael Hackett, a UNC doctoral student who got an idea 2 years ago for a potential commercial
drug: to trick tumors into absorbing chemotherapy
drugs by designing a molecular Trojan horse.
We currently do not know how these genetic risk factors affect the chemistry of the brain and cause specific symptoms, so it is not yet possible for scientists to
design drugs to relieve symptoms shown
by people with a particular genetic variant.
Chemotherapy
drugs designed to kill tumors may actually encourage ovarian cancer
by stimulating the growth of cells that give rise to the malignancy, a new study finds.
Chemotherapy
drugs are often
designed to kill off malignant cells
by damaging their DNA until they transition to a programmed death mode called apoptosis.
Published in the journal Molecular Cancer Therapeutics, the study also found that use of a second inhibitor might improve the effectiveness of these
drugs by possibly preventing resistance, and it recommends that clinical trials should be
designed to include a second inhibitor.
It also suggests the possibility of
designing better sleeping pills
by finding compounds that mimic adenosine's effects, says McCarley, who points out that current
drugs do not target the adenosine receptors.
People working in biomanufacturing need to be prepared for inspections
by the US Food and
Drug Administration and the European Medical Evaluation Agency
designed to ensure that mass - produced proteins are of the same quality as those used in clinical trials.
Since many human diseases can be explained
by perturbations of molecular interactions within cells, interactomes will drastically change how we think about human health, and how we set about
designing drugs and preventive measures to counter illness.
Most
drugs are
designed to interfere with a specific disease pathway
by elbowing their way into important spots inside the cell.
«This will require discussions about alternative approaches to the
design and conduct of clinical trials as well as to how interventions are approved
by the Food and
Drug Administration.»
A statin
drug commonly used to lower cholesterol is not effective in reducing the number and severity of flare ups from chronic obstructive pulmonary disease (COPD), according to the results of a large multicenter clinical trial
designed and directed
by Gerard J. Criner, MD, Director of Pulmonary and Critical Care Medicine at Temple University Hospital in Philadelphia, PA..
The determination of each efficacy level was also based on the rigor and quantity of published studies on the
drug class: to be in Level A, for example, a class of
drugs must have been supported
by at least two «Class I» studies — well -
designed, double - blind, randomized, placebo - controlled clinical trials.
The researchers targeted mTOR with an experimental
drug based on a prototype first
designed by Shokat, a chemist and an expert in
designing molecules to target this type of protein, called a kinase.
Other experimental options include: — AVI - 7537, a
drug designed to block viral protein from being made, has shown human tolerability in early studies and could have 100 courses available
by early 2015.
«Imaging of the joint could help evaluate the mechanism of a
drug's therapeutic effect, and if a process turns out to be mediated
by more than one chemoattractant, understanding the mechanism would allow the rational
design of combination therapies to completely shut down critical steps in the process.»
In medicine, biotechnology and pharmacology,
drug discovery is the process
by which
drugs are discovered and / or
designed.
He's also likely to spur the FDA to follow the course laid out
by agency cancer czar Richard Pazdur in speeding new approvals, possibly setting up a special unit aimed at orphan
drugs to hasten OKs with smaller, better
designed clinical trials.
«Some psychotic disorders may be induced
by drugs designed to combat effects of epilepsy.»
Downing and the team evaluated the strength of clinical trial evidence supporting FDA approval decisions for new
drugs by characterizing key features of efficacy trials, such as trial size,
design duration, and end points.
In one set of tests
designed to quantify how much the rats desired each
drug, they could get another infusion only
by making ever - greater numbers of lever presses.
A molecule in cells that shuts down the expression of genes might be a promising target for new
drugs designed to treat the most frequent and lethal form of brain cancer, according to a new study
by researchers at The Ohio State University Comprehensive Cancer Center — Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC — James).
Designed by researchers at Sangamo Biosciences, the
drug uses a natural protein that turns on the patient's own gene for helping nerve growth.
Scientists say that the new
design may eliminate the problems with the failed 2002 vaccine (manufactured
by Elan Corporation, an Ireland - based
drug company).
«We hope this technology will in future enable researchers to
design personalised diets or
drugs that can efficiently target problem areas in the gut, to help the millions of people worldwide that are affected
by digestive disorders and diseases.»
The experiment was
designed by pharmaceutical firm Novartis, which will use the data to
design drugs to combat the disease.
Led
by two groups — the Coalition for Mercury - free
Drugs and SafeMinds — they have brought the thiomersal «debate» into negotiations
designed to address environmental problems.
«Given that marijuana is the most commonly used illicit
drug by high school students in the U.S., having a better understanding of how marijuana use affects future SC use and vice versa is essential for
designing effective prevention and intervention programs.»
By performing experiments in petri dishes and with mice, they found that panobinostat, a
drug designed to change the way cells regulate genes, may be effective at inhibiting DIPG growth and extending survival rates.
Antisense
drugs are
designed to enter cells and eliminate viruses
by preventing their replication, Bavari explained.
We refer to these as «alerts»: they can be used
by drug design experts to try to avoid certain interactions and / or structures in order to develop safer
drugs,» says Aloy.
In
drug design, for example, the function of a protein is determined
by sequence comparison and 3D modelling programs.
«The hydrogel is
designed so that
drug release is triggered
by the activity of specific, arthritis - related enzymes that are increased during flares.
It was the first
drug designed to inhibit new vessel growth (angiogenesis), and was approved
by the FDA in 2004 for treating colorectal cancers — which typically boost angiogenesis to keep themselves well supplied with oxygen and nutrients.
These are the first ever
drugs specifically
designed to prevent the crippling headaches before they start, and they could be approved
by the U.S. Food and
Drug Administration next year.
A team of researchers led
by biophysicists at the University of Washington have come one step closer to
designing tailor - made
drug molecules that are more precise and carry fewer side effects than most existing therapeutic compounds.
«Now, because we know the resistance mechanism, we can
design elements to minimize the emergence of resistance as these promising new
drug candidates are developed,» said Ben Shen, a TSRI professor who led the study, which was published February 20, 2014 online ahead of print
by the Cell Press journal Chemistry & Biology.
While the United States focuses on figuring out how to keep
drugs and other chemicals out of the nation's waterways, the European Union's approach could be called «benign
by design.»