Sentences with phrase «of new drug applications»

Interacted with Clinical Research personnel to design and generate laboratory reports for the safety section of New Drug Applications.

Utilizing SAS, provided customized statistical tables, listings and graphs for the statistical section of New Drug Applications.

After law school Mr. Goan worked as In - House Counsel for Pharmakon Labs, Inc., where he assisted in the filings of new drug applications and developed standard operating procedures in compliance with the Federal Code of Regulations.

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

This designation enables Aura to have more frequent interactions with the FDA throughout AU - 011's drug development process, as well as priority review of the New Drug Application (NDA).

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 application.

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.

Slavitt said EpiPen has patent protection, has no Food and Drug Administration - approved equivalents, and was approved by that agency under a «new drug application,» all of which make it a brand - name dDrug Administration - approved equivalents, and was approved by that agency under a «new drug application,» all of which make it a brand - name ddrug application,» all of which make it a brand - name drugdrug.

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).

February 6, 2017 — Aura Biosciences Receives FDA Clearance of Investigational New Drug Application for Light - activated AU - 011 for the Treatment of Ocular Melanoma

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).

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.

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.

Outside of the Philippines, applications for food or food and feed safety review of GR2E Golden Rice have been submitted to the US Food and Drug Administration, Food Standards Australia New Zealand, and to Health Canada.

The University of Tokyo conducts world - class interdisciplinary research, emphasizing translational applications and drug development with its new facilities.

But she believes that the new thermoset could also eventually extend into a range of applications — anticorrosive and antimicrobial coatings, drug delivery, adhesives, 3 - D printing, water purification, among others.

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.

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 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.

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.»

Dr Wenxin Wang is trying to uncover therapies for diseases such as diabetic ulcers and Epidermolysis Bullosa, which causes chronic skin conditions: «We are currently investigating the use of these new materials for biomedical applications such as drug / gene delivery, cross linkable hydrogel materials and skin adhesives.

She is now developing new biomaterials which support cell regrowth, nano - encapsulation for targeted release of drugs and new drug candidates for skin and aging applications.

Because of their unique branchlike molecular architecture, the polymers have unusual physical properties and could be used in a wide range of applications, from biodegradable capsules for delivering drugs to new industrial lubricants.

At CeMM, a number of key discoveries on new applications for approved drugs have already been made with the CLOUD.

New studies — prompted by a renewed interest in potential applications of psychedelic drugs for understanding the brain or even treating some psychiatric diseases — suggest that far - reaching changes in brain connectivity contribute to the altered states of consciousness and other effects of an acid trip.

But, after Theravance submitted its second application on 30 June 2010, the FDA decided instead that applicants needed to show that patients were no more likely to die — of any cause — within 28 days of treatment with a new drug.

As a field, Carter observes, biology is still growing up and dealing with the fact that major societal applications are arising from the science developments of the last 30 years, ranging from new drugs against disease to the cloning of livestock.

«New drug triggers tissue regeneration: Faster regrowth and healing of damaged tissues: Research focuses on select tissues injured through disease, surgery and transplants, but early findings indicate potential for broad applications.»

This has applications in the manufacturing of new chemical products that can be used in industry, including new drugs for cancer therapy and new electronics for computers.

This new sustained - release drug therapy can provide months of relief to glaucoma patients with a single application, compared to just hours with today's conventional eye drops.

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.

The team's new approach could help generate a range of reliable stimuli - responsive materials, which can be used in memory devices, artificial muscles and drug delivery systems, among other applications.

Pending approval through an Investigative New Drug Application, the aerosolized form of the vaccine will be evaluated for replication, safety and immunity development in a study in adults.

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.

This permits new insights into organisms and creates the potential for a wide range of applications — from more exact delineation of tumor and metastasis through to tracking drug responses within whole - body imaging.

April 23, 2018 Ultragenyx Announces Filing and FDA Clearance of an Investigational New Drug Application for DTX401, a Gene Therapy for the Treatment of Glycogen Storage Disease Type Ia

Dr. Kanner brings more than 25 years of experience in drug discovery and development and will lead Caribou's research and development of new applications for its gene editing technology.

Although this classification was removed a decade later, since 1965, in order to conduct clinical studies of Coley's Toxins, investigators are required to submit an Investigational New Drug (IND) application with the FDA.

Our Human Emulation System sets a new standard for recreating true - to - life human biology and is being used to advance product innovation, design, and safety across a range of applications including drug development, agriculture, cosmetics, chemical - based consumer products, and personalized health.

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.

Multi-targeted therapy of cancer by niclosamide: A new application for an old drug.

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.

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.

The application of Dr. Snyder's techniques has enhanced the development of new agents in the pharmaceutical industry by enabling rapid screening of large numbers of candidate drugs.

Moderna will fund and be responsible for discovery and preclinical development of product candidates, with the aim of delivering one Investigational New Drug (IND) application - ready molecule for each of the two programs.

Repurposing refers to the reuse of conventional drugs with distinct indications for new applications in order to speed up drug development by capitalizing on previous knowledge and safety data.

UNITY recently completed Investigational New Drug (IND) application - enabling studies of UBX0101 and plans to submit an IND application in 2018.