Sentences with phrase «[investigational new drug applications»

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 drug.

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 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 (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.

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.

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 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.

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

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.»

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

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

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.

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

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.

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 trials.

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

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

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

According to Prothena, «An Investigational New Drug application, or IND, for PRX002 was filed and accepted by the FDA in March 2014.

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.

Reykjavik, ICELAND, January 13, 2005 — deCODE genetics (Nasdaq: DCGN) has submitted an investigational new drug application (IND) to the U.S. Food and Drug Administration (FDA) for DG041, a novel, first - in - class, orally - administered small molecule for the treatment of...

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.

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.

Investigational New Drug Application (IND)-- a key step in development of a new drug or medical treatment in which the US Food and Drug Administration (FDA) is notified that a novel therapeutic will be used experimentally

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.

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.

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.

Represented Dr. Reddy's Laboratories (DRL) against Celgene in Hatch - Waxman patent infringement litigation involving DRL's abbreviated new drug application to the FDA for a generic version of Revlimid (lenalidomide).

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.

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.

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

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

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.

In particular, he counsels clients in Abbreviated New Drug Application (ANDA) cases under the Hatch - Waxman Act.

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).

Patent holders previously made such claims in order to delay the onset of competition from generic drug manufacturers, by preventing or delaying FDA approval of a generic manufacturer's Abbreviated New Drug Application (ANDA).

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

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