Sentences with phrase «drug trial applications»

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, Maryland.

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.

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.

The FDA added that «additional well - controlled clinical trials are needed prior to the resubmission of the [new drug application] for ALKS 5461,» the release said.

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).

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

Given the clinical trial results underpinning a new drug application for Kite Pharma's lead candidate, which the Food and Drug Administration is currently reviewing, I'd say there's a solid chance Gilead can squeeze out a return on its investmdrug application for Kite Pharma's lead candidate, which the Food and Drug Administration is currently reviewing, I'd say there's a solid chance Gilead can squeeze out a return on its investmDrug Administration is currently reviewing, I'd say there's a solid chance Gilead can squeeze out a return on its investment.

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.

Those services include clinical trials management and U.S. Food and Drug Administration (FDA) new drug submissions and marketing applicatiDrug Administration (FDA) new drug submissions and marketing applicatidrug submissions and marketing applications.

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 embryos.

I prepared clinical - trial protocols, grants, and new - drug applications.

He moderated a premeeting session where scientists discussed advances with officials of the U.S. Food and Drug Administration, which would review any application for a clinical trial.

He has initiated multiple trials under investigational new drug applications using infused T cells and natural killer (NK) cells.

In the first FDA - approved trial evaluating the street drug's therapeutic applications, it proved phenomenally successful at treating PTSD.

He will assemble a group of people to voluntarily try an existing drug for a new application before a pharmaceutical company embarks on a bigger, more costly human trial.

Since the mid-1990s, FDA has deemed that organisms used in challenge studies are experimental medicines, and the agency has required researchers to submit Investigational New Drug applications before conducting trials.

Raman says the next big steps are in overcoming the technical challenges of delivering the drug, and completing the experiments essential to file for an Investigational New Drug Application with the Food and Drug Administration to start clinical tridrug, and completing the experiments essential to file for an Investigational New Drug Application with the Food and Drug Administration to start clinical triDrug Application with the Food and Drug Administration to start clinical triDrug Administration to start clinical trials.

Medical writers produce the documents that help companies push a drug or device from clinical trials through FDA approval, including literature summaries, applications to FDA to investigate a new device or drug, and documents intended for review by institutional review boards (IRBs).

The Food and Drug Administration is currently reviewing an application for a phase III trial of psilocybin, the last step before the therapy could be approved.

Her expertise includes optimization of standard operating procedures for cGMP manufacture of transgenic T cells, stem cells and dendritic cells to be used in clinical trials, planning and writing clinical trial protocols, IND (investigational new drug) applications and other regulatory documents.

The $ 1 million grant will be used for preclinical trial work with the goal of submitting an Investigational New Drug application to the FDA to begin clinical trials.

This approach enables us to leapfrog over several years of drug discovery and development and to go straight into information - rich trials, accelerating the application in the clinic of our gene discoveries and generating product - driven value for the company,» said Kari Stefansson, CEO of deCODE.

The results of long - term safety studies in mice were previously submitted to the Food and Drug Administration to gain permission for a Phase 1 clinical trial under an Investigational New Drug (IND) application.

Human embryonic stem cellsImage: Wikimedia commons, Nissim Benvenistylinkurl: Advanced Cell Technology; http://www.advancedcell.com/ (ACT) filed an Investigational New Drug (IND) application yesterday (November 18) to conduct a phase I / II trial using hESCs to treat a genetic eye disease.

Other applications include designing clinical trials to identify at - risk populations for adverse drug reactions.

ViaCyte, Inc. announced in July 2014 that it had filed its first Investigational New Drug application (IND) with the United States Food and Drug Administration (FDA) seeking to initiate a Phase 1/2 clinical trial in patients with type 1 diabetes, and in August 2014 the IND was accepted, allowing clinical testing to commence.

The Investigational New Drug application for the Phase 1/2 trial, called STEP ONE, or Safety, Tolerability, and Efficacy of VC - 01 Combination Product in Type 1, was allowed by the US Food and Drug Administration in August 2014.

Clinical application of pharmacogenomics knowledge will result in less «trial and error» prescribing and more efficacious, safer and cost - effective drug therapy.

In May, the Food and Drug Administration linkurl: placed a hold; https://www.the-scientist.com/blog/display/54647/ on a clinical trial application submitted by Geron Corporation, a California - based biotech.

The approval process involves several steps including preclinical laboratory and animal studies, clinical trials for safety and efficacy, filing of a New Drug Application by the manufacturer of the drug, and FDA review and approval of the applicatDrug Application by the manufacturer of the drug, and FDA review and approval of the aApplication by the manufacturer of the drug, and FDA review and approval of the applicatdrug, and FDA review and approval of the applicationapplication.

Application of the CFU - GM assay to predict acute drug - induced neutropenia: an international blind trial to validate a prediction model for the maximum tolerated dose (MTD) of myelosuppressive xenobiotics

A drug company filed its application in early 2011 for the drug naltrexone for weight loss; in clinical trials, naltrexone was successful, with participants losing 22 pounds per month by reducing calorie intake 400 calories per day.

Clinical trials have shown safety and effectiveness in easing RLS symptoms in the course of 12 weeks, and the FDA recently asked Solzira's manufacturer to reorganize and resubmit its application for drug approval consideration.

In my corner of the industry, all of our studies are focused on real world application of these products — that is to say, we are monitoring patients using drugs that have been approved and are available for regular consumption — not just a clinical trial.

Lex Machina's Patent Litigation Year in Review surveys and summarizes key trends that have emerged over the past year, drawing upon its platform that combines data from PACER, the Patent Trial and Appeal Board (PTAB), International Trade Commission (ITC), U.S. Food and Drug Administration (FDA) and Orange Book on Abbreviated New Drug Applications (ANDAs), among others.

Directed design, implementation and monitoring of clinical trials, preparation of INDs and periodic study reports for New Drug Applications, and ensured (GCP) was maintained.

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