Sentences with phrase «from drug design»

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.
Sysco says he suspected the technology would need to gain FDA approval from the time the company launched in 2005, because it was designing an app that physicians would prescribe like a drug or device.
• Rani Therapeutics, a San Jose, Calif. - based developer of a pill designed to replace injectable drug delivery for patients suffering from chronic diseases, raised $ 53 million in funding.
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 announcement from Juul (JOO - «uhl) Labs comes one day after the Food and Drug Administration questioned the design and marketing of the company's small, sleek vaping devices.
Celgene's lead product, Revlimid, a drug designed to treat multiple myeloma and a few other cancer types, has been benefiting from longer duration of use, strong pricing power, and high multiple myeloma market share.
I and others of like mind criticized the drug culture and related antics as a self - indulgent distraction from the goals of racial justice and peace, and worried that the new enthusiasm for «ecological consciousness» was in fact a conservative ploy designed to turn the movement away from the cause of the poor.
Major League Baseball's policies to prevent the use of performance - enhancing drugs seemed designed to keep anyone from ever risking the full extent of the punishments.
She has received more than 40 grants from the National Institute of Mental Health and the National Institute on Drug Abuse to design prevention programs for children and families at high risk for HIV, mental health problems, suicide, and substance abuse.
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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
«The results from this framework will facilitate the quantitative prediction of the responses of individual subjects as well as the design of optimal drug treatments,» the researchers noted in a recent special issue of Advanced Drug Discovery Revidrug treatments,» the researchers noted in a recent special issue of Advanced Drug Discovery ReviDrug Discovery Reviews.
This open layout means that Bio21 students, primarily graduate students and postdocs, are assured of opportunities to interact with researchers from a variety of disciplines; a biochemistry student, for example, has the opportunity to work — and chat — with chemists who are designing molecules for potential drugs, or geneticists, or pharmacologists.
A paper published today in Nature describes how a group of scientists from Stanford University, collaborating with the MRC in Cambridge, The University of California, San Francisco and the Universities of Melbourne used cutting - edge technology to design a smarter drug to combat the resistant strain.
To administer the drug systemically, they're working to design an injectable formulation that protects the peptide from breaking down in the body, makes it more selective, and directs it to the site of infection.
«You can really see the underlying mechanisms, and that has a ton of implications — from understanding how life works to drug design,» said Laszlo.
Now that researchers know from their cell studies that this family of receptors can essentially flip its own switch, they can use that information to design drugs to prevent that from happening when it shouldn't.
To measure risky online self - presentation the research team, which also included PhD student Clara Cutello, Dr Michaela Gummerum and Professor Yaniv Hanoch from the School of Psychology, designed a risk exposure scale relating to potentially inappropriate images or texts, such as drug and alcohol use, sexual content, personal information, and offensive material.
«Our computer aided drug screening process has now identified two new classes of anti-cancer agents, specifically targeting two distinct and novel mechanisms underpinning cancer,» said Dr Andrea Brancale from Cardiff University's School of Pharmacy, who led on the compound's design.
«Now the challenge is to design experimental studies using biomarkers in cognitively normal people to determine who can really benefit from the drugs
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..
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.
An inhalable drug is designed to move straight from the lungs to the heart, where it is hoped it will prevent the organ from deteriorating after heart attacks
There are multiple techniques currently being studied for this type of drug delivery mechanism, from microneedles to iontophoresis (transdermal drug delivery via electric current), but the Kumamoto University researchers designed to improve a technique called transdermal thermal ablation.
Today it announced that a CRC - funded professor will move his gene - targeted drug design research group from the university.
Professor Davis, author of the popular Penguin paperback The Compatibility Gene, concludes: «The practical application of this basic research comes from bouncing around our ideas with scientists working on drug design.
An experimental drug designed to help regulate the blood's iron supply shows promise as a viable first treatment for anemia of inflammation, according to results from the first human study of the treatment published online today in Blood, the Journal of the American Society of Hematology
The researchers are using «big data» concepts and techniques to discover and design new nanomaterials — a priority area under the White House's Materials Genome Initiative — using a methodology that will revolutionize materials design, impacting a broad range of products that affect our daily lives, from drugs and agricultural chemicals such as pesticides or herbicides to fuel additives, paints and varnishes, and even personal care products such as shampoo.
In this collaboration, Dickerson designed the synthesis of drugs from precursor compounds prior to scheduling, when they are not available from research supply companies.
Although SU101 is designed to sabotage messages from a particular messenger chemical, the approach could open the door to a range of new cancer drugs.
Dr Ishwar Singh, a specialist in novel drug design and development from the University of Lincoln's School of Pharmacy, said: «Translating our success with these simplified synthetic versions from test tubes to real cases is a quantum jump in the development of new antibiotics, and brings us closer to realising the therapeutic potential of simplified teixobactins.
These new nanoparticles are equipped with specially designed nanovalves that can control release of anticancer drugs from thousands of pores, or tiny tubes, which hold molecules of chemotherapy drugs within them.
Scientists and physicians have tried countless methods to treat the nightmares, anxiety, and flashbacks of posttraumatic stress disorder (PTSD) in soldiers, from talk therapy to drugs designed to press the «delete» button on specific memories.
Researchers from the Centre for Genomic Regulation (CRG) and Consejo Superior de Investigaciones Científicas (CSIC) have designed mathematical models that will allow us to understand basic concepts of metabolic and genetic regulatory systems as well as to optimize the production of drugs and other biotechnological products.
The researchers caution that the reliable detection of small to moderate risks and benefits of drug therapies requires cogent data from large - scale randomized trials designed a priori to test the hypothesis.
And for those suffering from an allergy to some grasses, the Food and Drug Administration's (FDA) approval of the oral dissolvable tablets designed to help treat symptoms may be beneficial.
Once they identified the function of the protein, Moore's research team was able to design a biologic drug that can prevent the messenger RNA gene from creating HE4.
The study could help identify people who would most benefit from new drugs designed to save brain cells, but more research is necessary to determine if the genetic mutations are implicated in disease.
But if you knew that the effect of a drug had a lot to do with whether you inherited specific genes from your mother or father, then you could design an experiment that would include parents.
When asked about the ethics of offering a drug to people who may never get the disease it's designed to prevent, Michael Sand, the Boehringer scientist overseeing the clinical trial, acknowledges that psychosis risk prediction is far from perfect.
As the pace of drug approvals accelerates and the U.S. Food and Drug Administration (FDA) faces potential budget cuts, a new research design from Perelman School of Medicine scientists offers a new way to successfully assess safety of newly approved drugs, as well as drugs that have been on the market for a long time and have had a marked rise in their drug approvals accelerates and the U.S. Food and Drug Administration (FDA) faces potential budget cuts, a new research design from Perelman School of Medicine scientists offers a new way to successfully assess safety of newly approved drugs, as well as drugs that have been on the market for a long time and have had a marked rise in their Drug Administration (FDA) faces potential budget cuts, a new research design from Perelman School of Medicine scientists offers a new way to successfully assess safety of newly approved drugs, as well as drugs that have been on the market for a long time and have had a marked rise in their use.
In a development that could lead to a new generation of drugs to precisely treat a range of diseases, scientists from the Florida campus of The Scripps Research Institute (TSRI) have for the first time designed a drug candidate that decreases the growth of tumor cells in animal models in one of the hardest to treat cancers — triple negative breast cancer.
New insights from neutron analysis of glaucoma drugs and their enzyme target may help scientists design drugs that more effectively target aggressive cancers.
Professor Alvaro Mata, from Queen Mary's School of Engineering and Materials Science, said: «The technique opens the possibility to design and create biological scenarios like complex and specific cell environments, which can be used in different fields such as tissue engineering by creating constructs that resemble tissues or in vitro models that can be used to test drugs in a more efficient manner.»
«It's a powerful lesson from nature with respect to drug design,» explains Cole, co-author and EPFL professor.
The ProVision 100 is a computer system with software which converts data such as simulations of drug molecules or architects» designs from a two - dimensional format into three dimensions.
The research could help other scientists to use cryo - EM in structure - based drug design studies — in which researchers build the best possible drugs starting from a molecule which already binds to the active site of a target protein.
Alterations in the genetic coding for a nerve cell receptor, which detects a chemical signal that is key to behavioral change, could point the way to designing therapies most effective for patients suffering from schizophrenia, drug addiction and other mental illnesses.
Antisense inhibitors are synthetic nucleic acid drugs that can be designed to selectively bind to messenger RNA from the targeted, disease - linked gene, and inactivate it.
There are many stages in the drug discovery / development process from target identification, assay design, and screening through to compound optimization, pharmacology, and testing in animal models.
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