Sentences with phrase «new drug application with»

Thera filed a new drug application with the U.S. Food and Drug Administration (FDA) for tesamorelin, a drug to reduce excess abdominal fat among HIV patients.

Actinobac plans to file an Investigational New Drug application with the Food and Drug Administration within the next two years.

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 trials.

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.

Not exact matches

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).

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 (Ndrug development process, as well as priority review of the New Drug Application (NDrug Application (NDA).

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

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

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.»

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

A study published on June 25th in PLOS Pathogens reports a new way to circumvent drug resistance and lower the curative dose by delivering existing drugs directly into the parasite, a high - tech approach with potential applications to other infectious diseases.

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.

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.

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.

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.

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.

Discussions with the US Food and Drug Administration (FDA) have confirmed that safflower - produced insulin is eligible to follow a shortened drug approval process and we have filed an Investigational New Drug (IND) application to the Drug Administration (FDA) have confirmed that safflower - produced insulin is eligible to follow a shortened drug approval process and we have filed an Investigational New Drug (IND) application to the drug approval process and we have filed an Investigational New Drug (IND) application to the Drug (IND) application to the FDA.

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.

At the same time FSMA is now extending its contract with deCODE to continue work towards an Investigational New Drug (IND) application with the Food and Drug Administration.

In 1998, the U.S. Congress mandated a new question on the Free Application for Federal Student Aid (FAFSA) in order to prevent applicants with prior drug - related convictions (whether felony or misdemeanor) from receiving federal financial aid, including Pell Grants, Stafford Loans, and work - study.

In connection with this goal, Vanda's management team has been working diligently over the past several months with the Food & Drug Administration («FDA») to reevaluate its response to Vanda's New Drug Application («NDA») for iloperidone for the treatment of schizophrenia.

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.

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.

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