Sentences with phrase «drug application in»

The modified E. coli bacterium has been able to maintain an unnatural base pair, fueling hopes of new drug applications in the future.

This exclusive new peer - reviewed journal couples our Brief format with the most complete picture of drug applications in clinical practice from leading veterinary authorities, featuring concise, hands - on, real - world practical applications.

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 NDIn 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 NDin 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 NDin the FDA issuing a refusal to file letter to Celgene regarding the NDA.

The combo proved non-inferior to competing HIV medicines in a slew of late - stage clinical trials, and Gilead is expected to file a new drug application with the FDA soon.

In outcome - based pricing, drug companies will know that payment is coming if the treatment works, and that means more incentive to develop new cures and to find new applications for existing drugs.

Premier's Alkire said the FDA needs to approve and reduce the backlog of drug applications that are stuck in the pipeline.

There is at least some good news: The FDA in May approved Radicava, the first ALS drug greenlighted in 22 years on an application by the Mitsubishi Tanabe Pharma Corporation, a subsidiary of the tech giant.

The application also analyzes keywords in comments and posts and notifies parents if there are references to drugs, violence and suicide and words commonly used in cyberbullying.

These risks and uncertainties include: Gilead's ability to achieve its anticipated full year 2018 financial results; Gilead's ability to sustain growth in revenues for its antiviral and other programs; the risk that private and public payers may be reluctant to provide, or continue to provide, coverage or reimbursement for new products, including Vosevi, Yescarta, Epclusa, Harvoni, Genvoya, Odefsey, Descovy, Biktarvy and Vemlidy ®; austerity measures in European countries that may increase the amount of discount required on Gilead's products; an increase in discounts, chargebacks and rebates due to ongoing contracts and future negotiations with commercial and government payers; a larger than anticipated shift in payer mix to more highly discounted payer segments and geographic regions and decreases in treatment duration; availability of funding for state AIDS Drug Assistance Programs (ADAPs); continued fluctuations in ADAP purchases driven by federal and state grant cycles which may not mirror patient demand and may cause fluctuations in Gilead's earnings; market share and price erosion caused by the introduction of generic versions of Viread and Truvada, an uncertain global macroeconomic environment; and potential amendments to the Affordable Care Act or other government action that could have the effect of lowering prices or reducing the number of insured patients; the possibility of unfavorable results from clinical trials involving investigational compounds; Gilead's ability to initiate clinical trials in its currently anticipated timeframes; the levels of inventory held by wholesalers and retailers which may cause fluctuations in Gilead's earnings; Kite's ability to develop and commercialize cell therapies utilizing the zinc finger nuclease technology platform and realize the benefits of the Sangamo partnership; Gilead's ability to submit new drug applications for new product candidates in the timelines currently anticipated; Gilead's ability to receive regulatory approvals in a timely manner or at all, for new and current products, including Biktarvy; Gilead's ability to successfully commercialize its products, including Biktarvy; the risk that physicians and patients may not see advantages of these products over other therapies and may therefore be reluctant to prescribe the products; Gilead's ability to successfully develop its hematology / oncology and inflammation / respiratory programs; safety and efficacy data from clinical studies may not warrant further development of Gilead's product candidates, including GS - 9620 and Yescarta in combination with Pfizer's utomilumab; Gilead's ability to pay dividends or complete its share repurchase program due to changes in its stock price, corporate or other market conditions; fluctuations in the foreign exchange rate of the U.S. dollar that may cause an unfavorable foreign currency exchange impact on Gilead's future revenues and pre-tax earnings; and other risks identified from time to time in Gilead's reports filed with the U.S. Securities and Exchange Commission (the SDrug Assistance Programs (ADAPs); continued fluctuations in ADAP purchases driven by federal and state grant cycles which may not mirror patient demand and may cause fluctuations in Gilead's earnings; market share and price erosion caused by the introduction of generic versions of Viread and Truvada, an uncertain global macroeconomic environment; and potential amendments to the Affordable Care Act or other government action that could have the effect of lowering prices or reducing the number of insured patients; the possibility of unfavorable results from clinical trials involving investigational compounds; Gilead's ability to initiate clinical trials in its currently anticipated timeframes; the levels of inventory held by wholesalers and retailers which may cause fluctuations in Gilead's earnings; Kite's ability to develop and commercialize cell therapies utilizing the zinc finger nuclease technology platform and realize the benefits of the Sangamo partnership; Gilead's ability to submit new drug applications for new product candidates in the timelines currently anticipated; Gilead's ability to receive regulatory approvals in a timely manner or at all, for new and current products, including Biktarvy; Gilead's ability to successfully commercialize its products, including Biktarvy; the risk that physicians and patients may not see advantages of these products over other therapies and may therefore be reluctant to prescribe the products; Gilead's ability to successfully develop its hematology / oncology and inflammation / respiratory programs; safety and efficacy data from clinical studies may not warrant further development of Gilead's product candidates, including GS - 9620 and Yescarta in combination with Pfizer's utomilumab; Gilead's ability to pay dividends or complete its share repurchase program due to changes in its stock price, corporate or other market conditions; fluctuations in the foreign exchange rate of the U.S. dollar that may cause an unfavorable foreign currency exchange impact on Gilead's future revenues and pre-tax earnings; and other risks identified from time to time in Gilead's reports filed with the U.S. Securities and Exchange Commission (the Sdrug applications for new product candidates in the timelines currently anticipated; Gilead's ability to receive regulatory approvals in a timely manner or at all, for new and current products, including Biktarvy; Gilead's ability to successfully commercialize its products, including Biktarvy; the risk that physicians and patients may not see advantages of these products over other therapies and may therefore be reluctant to prescribe the products; Gilead's ability to successfully develop its hematology / oncology and inflammation / respiratory programs; safety and efficacy data from clinical studies may not warrant further development of Gilead's product candidates, including GS - 9620 and Yescarta in combination with Pfizer's utomilumab; Gilead's ability to pay dividends or complete its share repurchase program due to changes in its stock price, corporate or other market conditions; fluctuations in the foreign exchange rate of the U.S. dollar that may cause an unfavorable foreign currency exchange impact on Gilead's future revenues and pre-tax earnings; and other risks identified from time to time in Gilead's reports filed with the U.S. Securities and Exchange Commission (the SEC).

Cambridge, MA — February 6, 2017 — Aura Biosciences, a biotechnology company developing a new class of therapies to target and selectively destroy cancer cells using viral nanoparticle conjugates, announced today that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug application (IND) for the company's lead program, light - activated AU - 011 in ocular melanoma (Drug Administration (FDA) has cleared the investigational new drug application (IND) for the company's lead program, light - activated AU - 011 in ocular melanoma (drug application (IND) for the company's lead program, light - activated AU - 011 in ocular melanoma (OM).

The application states whether the drug has already been approved for marketing in the United States, the European Union, Switzerland, Singapore and / or Australia.

Celgene Corporation (NASDAQ: CELG) shares plummeted 10 percent Tuesday evening after the U.S. Food and Drug Administration rejected its New Drug Application for ozanimod in the treatment of relapsing multiple sclerosis.

Omeros Corporation (NASDAQ: OMER) shares are trading higher Tuesday after the commercial - stage biopharma company announced FDA approval for its supplemental new drug application, or sNDA, for OMIDRIA, which expands the indication to include use in pediatric patients, from birth through 17 years...

Celgene Corporation (NASDAQ: CELG) is under continued stock pressure Wednesday after the U.S. Food and Drug Administration rejected its New Drug Application for ozanimod in the treatment of relapsing multiple sclerosis.

Maintaining timely approvals for new drugs is vital for drugmakers, since there are dozens of drug approval applications awaiting assessment by the EU regulator in the next few years.

If myelofibrosis trial results are consistent with previous observations, the healthcare behemoth will help fund larger trials in order to support New Drug Applications.

Medicine and a host of next generation drugs, procedures, and gene therapies rely HEAVILY on evolutionary theory in their development and application.

And in March, Lush Fresh Handmade Cosmetics» packaging for creams and lotions, the Lush Black Pot, was recognized as the first US Food and Drug Administration rigid packaging application for cosmetics use made from recycled polypropylene (PP).

Bellamy's is due to lodge its application for the China Food and Drug Authority (CFDA) licence in the next few weeks, which if successful, will allow it to continue to sell its products into the world's biggest baby formula market next year.

Other mothers prefer to use hair setting tape (which can be found at a beauty supply or drug store) because it stays in place nicely during the feeding, but doesn't cause discomfort with repeated applications and removal.

Nick Clegg and Virgin boss Richard Branson will do a joint press conference today in which they'll call for those caught with drugs when they're young not to have their career prospects ruined by having to mention it in future job applications.

Researchers at NYU School of Medicine found that the value of the drug infliximab, marketed as Remicade, in both applications proceeds from its ability to block the contribution of the protein tumor - necrosis factor alpha, or TNF alpha, to problem - causing inflammation.

We thought that we could use some of our work in biomaterials for medical applications and controlled drug release to help heal those wounds.»

«Now that we have a more complete understanding of this stability, we can better tailor the nanoparticle morphologies and in turn properties, to applications from biolabeling of individual cells and targeted drug delivery to catalytic reactions, thereby creating more efficient and sustainable production processes.»

4.2.5 Submit articles and excerpts from the Licensed Materials to regulatory agencies in connection with applications for drug and product approval provided that such uses do not amount to commercial redistribution for direct profit; provided each article or excerpt from the Licensed Materials contains a credit line noting the original appearance of the article in its appropriate journal; provided any portion of the Licensed Materials used for these purposes looks identical to the original material; and provided such use does not present any material from the Licensed Materials in any manner that implies that Publisher endorses Licensee or any of the Licensee's products or services;

Rima Janusziewicz and Ashley R. Johnson, graduate students in DeSimone's academic lab, are co-authors on the paper and are working on novel applications in drug delivery and other areas.

I promptly chose to go into clinical pharmacy — the most exciting application of pharmaceutical knowledge — helping patients in the hospital maximize the effects of the drugs they are prescribed while minimizing the potential side effects.

Students learn their application when analyzing samples for dyes, such as those occurring on textile fibers; when analyzing samples for the presence of materials such as petrol which may have been used to start fires; or when testing for the presence of illicit drugs in a variety of sample types.

He has submitted his first clinical - trial application to the US Food and Drug Administration, and hopes to begin testing the rice - derived HSA in humans within the next two years.

The new material, described online 25 April in Science by synthetic chemist Andreas Lendlein of mnemoScience GmbH in Aachen, Germany, and biomedical engineer Robert Langer of the Massachusetts Institute of Technology, is composed of two polymers, each already used separately in clinical applications such as drug delivery.

In one application, Rogers» team devised a transient, flexible film to kill bacteria using electricity instead of drugs.

«This approach will allow the on - demand production of chemicals and drugs that are in short supply, hard to make at big facilities, and allow customization to tailor them to the application,» Cronin says.

These bubbles are thousands of times smaller than the tip of a pencil lead — so small they are invisible even under most optical microscopes — and their stability makes them useful in a variety of applications, from targeted drug delivery to water treatment procedures.

Some geochemists even hope that, as techniques improve, there could be applications in diagnosing diseases and measuring the efficacy of drugs on individuals.

In the United States, such clinical trials are effectively banned by a rule that prevents the Food and Drug Administration from reviewing applications for any procedure that would introduce heritable changes in human embryoIn the United States, such clinical trials are effectively banned by a rule that prevents the Food and Drug Administration from reviewing applications for any procedure that would introduce heritable changes in human embryoin human embryos.

IRBs are also included, along with many pages of other information, in drug trial applications with regulatory agencies such as the U.S. Food and Drug Administration (FDA) in Silver Spring, Maryldrug trial applications with regulatory agencies such as the U.S. Food and Drug Administration (FDA) in Silver Spring, MarylDrug Administration (FDA) in Silver Spring, Maryland.

Under this system, drug and device manufacturers pay the FDA user fees totaling more than $ 300 million — to be increased under the new law to at least $ 400 million — each year in exchange for speedier review of their applications.

The nanorods could have applications in such areas as electronics, sensory devices, energy conversion and storage, drug delivery, and cancer treatment.

The principle component of the new panel, hydrogel — a polymer network filled with water — is safe to use in and on the human body, having already found use in applications ranging from drug delivery to creating scaffolds for tissue engineering and wound healing.

He says such a tool could be useful for pharmaceutical chemists who want to mix and match chemical building blocks in many ways to search for new drugs — another application the researchers are working on.

Because of the legislation, a FDA spokesperson noted in an email, «the agency will not receive or review INDs [Investigational New Drug applications] for human subject research utilizing genetic modification of embryos for the prevention of transmission of mitochondrial disease in FY 2016 and human subject research using these technologies can not be conducted in compliance with the Federal Food, Drug, and Cosmetic Act and FDA's implementing regulations.»

As novel applications, such as drug screening, SNP detection, diagnostics, environmental monitoring, and food protection, are developed, there will be more demand for experienced microarray technicians in the workplace.

Carbon nanodots are tiny particles of carbon that are useful in imaging, sensing, drug delivery and many other applications.

Russell, her advisor, points out that the advance holds promise for a wide range of different applications including in drug delivery, biosensing, fluidics, photovoltaics, encapsulation and bicontinuous media for energy applications and separations media.

As their novel technique for drug delivery is non-invasive and easy to use, the NUS team envisioned that the microneedles patch has great potential for applications in clinical and home care settings for the management of perioperative pain and chronic pain in patients suffering from conditions like diabetes and cancer.

Sun is currently conducting collaborative research with hydrogels for applications and efficiency with anticancer drugs screening and delivery, stem cells and wound healing, as well as being used in vaccines for H1N1 influenza and animal diseases, such as the porcine reproductive and respiratory syndrome virus, or PRRS.

In the new study, DrugPredict suggested non-steroidal anti-inflammatory drugs, also known as NSAIDs, could have applications for epithelial ovarian cancer.

Hooker and Van de Bittner note, however, that the tool also has tremendous potential for research applications, particularly for drug discovery in smell - loss therapy and in understanding the relationships between olfactory neuron health and brain health more generally.

We can already see the beginnings of the application of such knowledge in using scanning technologies to diagnose schizophrenia and to detect subtle racist or sexist thought patterns as well as in implant surgery to treat parkinsonism and in the emergence of drugs such as Ritalin and Ambien.

In previous studies, pulsating magnetic fields have been used to deliver drugs, but the heat caused by the application can destroy healthy cells of patients.