Sentences with phrase «drug application»

Only one or two compounds will be submitted as a new drug application.

The term priority review voucher means a voucher issued by the Secretary to the sponsor of a material threat medical countermeasure application that entitles the holder of such voucher to priority review of a single human drug application submitted under section 505 (b)(1) or section 351 (a) of the Public Health Service Act after the date of approval of the material threat medical countermeasure application.

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.

There also could be arguments made for regulating cell - cultured meat under FDA's New Animal Drug Application process.

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

Because the researchers» investigational new animal drug application for the engineered sows is still under review by FDA, the agency considers the piglets «experimental» animals, which can not be sold for any purpose.

In a significant, yet unusual judgment the Court of Justice of the European Union (CJEU) upheld the General Court's decision (T - 140 / 12; Teva Pharma v. EMA) that had affirmed the European Medicines Agency's (EMA) rejection of Teva's generic drug application for Glivec ® (active substance - imatinib), not due to the reference product's own orphan drug exclusivity but in view of orphan drug exclusivity of a similar medicinal product — Tasigna ® (active substance - nilotinib).

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.»

The priority review user fee required by this subsection shall be due upon the submission of a human drug application under section 505 (b)(1) or section 351 (a) of the Public Health Service Act for which the priority review voucher is used.

Sandoz and other generic drug companies filed Abbreviated New Drug Applications seeking approval to market a generic form of the drug.

She has a particular focus on abbreviated new drug application cases.

Biotech stocks appeared to have topped out for the year after Celgene Corp. triggered a broad - based decline after withdrawing a critical drug application.

2018 will see data readouts on eight phase 3 trials, initiation of eight other phase 3 or pivotal trials, and several New Drug Application submissions.

The data from the study is the foundation for two New Drug Applications currently pending before the FDA for use of the drug to treat DMD.

The team is conducting additional research toward an investigational new drug application from the federal Food and Drug Admission.

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

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.

An approvable letter indicates that the FDA is prepared to approve a new drug application once certain specified conditions, such as a request for additional information, are met.

The National Institute of Neurological Disorders and Stroke (NINDS) has selected SMA to serve as the prototype for a translational research project that is expected to yield drug candidates for investigational new drug application filings by 2007.

Represented pharmaceutical company in size determination proceedings before the Small Business Administration arising from request for small business waiver of prescription drug fee for review of human drug application.

In addition to expanding the «grace period» from six to 12 months, and introducing the «patent term adjustment» mechanism to compensate for the patent office's delay in patent examination, the proposed amendment also provides the «patent linkage system» — according to such, the owner of the new drug patent may file patent infringement litigation during the examination course of the generic drug application.

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

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.

Teva filed an Abbreviated New Drug Application seeking market approval for a generic form of Helsinn's product, and Helsinn responded by filing an infringement action asserting all four patents against Teva.

Their cocktail therapy adding bictegravir to its mainstays emtricitabine / tenofovir alafenamide (200 / 25 mg)(FTC / TAF) proved non-inferior to dolutegravir and other antiretroviral therapies in the 4 late - stage studies, setting up a new drug application in a matter of weeks as Gilead races to a near - term marketing OK.

Last week, the Food and Drug Administration approved a supplemental New Animal Drug Application...

Simply put, the industry believed that the FDA was eating up the length of its patents, and profits, because of its slowness in processing new drug applications.

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.

Intarcia is expected to seek a new drug application for the product from the FDA soon, says Christine Aylward, managing director at Foresight Capital Management, which has backed the company.

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 drug.

The sponsor of a human drug application shall notify the Secretary not later than 90 calendar days prior to submission of the human drug application that is the subject of a priority review voucher of an intent to submit the human drug application, including the date on which the sponsor intends to submit the application.

The Secretary shall establish a user fee program under which a sponsor of a human drug application that is the subject of a priority review voucher shall pay to the Secretary a fee determined under paragraph (2).

«We look forward to submitting a new drug application for sarecycline and bringing to market a potential new option for physicians treating patients with acne.»

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 (OM).

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).

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

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.

These Abbreviated New Drug Applications, or ANDAs, are hardly abbreviated; estimates in 2006 suggested the average time for a decision was 17 months.

At the top of the list is submission of a New Drug Application for ALKS 5461, expected this month.