Sentences with phrase «new drug application»

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

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

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

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

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.

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.

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 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.

In calendar year 2014, the FDA's Center for Drug Evaluation and Research (CDER) approved 41 novel new drugs as new molecular entities (NMEs) under New Drug Applications (NDAs) or as new therapeutic biologics under Biologics License Applications (BLAs).

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.

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...

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.

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 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.

The new data from Celgene also make ozanimod the first compound originating from the National Institutes of Health's (NIH) Molecular Library Initiative to successfully complete phase 3 clinical trials for safety and efficacy with data to support an FDA new drug application.

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.

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.

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.

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

Daniel Attaway represents pharmaceutical and biotech patent holders in Abbreviated New Drug Application («ANDA») and related patent litigation.

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

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

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 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.

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.

«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.»

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).

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.

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.

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 investment.

Also, if a pharmaceutical agent like GHRP - 6 is indicated for a skin condition there will be numerous studies and a new drug application to review.

Merrimack expects to submit a New Drug Application this year to the U.S. Food and Drug Administration (FDA) for the MM - 398 combination regimen.

Shannon's company was instrumental in three of the 21 new drug applications the FDA approved last year.

Over at the FDA's CDER, B.S. and M.S. graduates are hired as regulatory project managers for new drug applications.

In June the FDA accepted the company's New Drug application for ixabepilone, and, based on expectations, a decision should have been announced in October.

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.

Sarepta Therapeutics, which funded the study, plans to submit a New Drug Application to the Food and Drug Administration early next year.

San Diego, May 22, 2017 — ViaCyte, Inc., a privately - held leading regenerative medicine company, announced today that the U.S. Food and Drug Administration (FDA) has allowed the company's Investigational New Drug Application (IND) for the PEC - Direct ™ product candidate, a novel islet cell replacement therapy in development as a potential cure for patients with type 1 diabetes who are at high risk for acute life - threatening complications.

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.