Sentences with phrase «new drug application for»

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.

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

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.

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.

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.

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.

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

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).

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.

In outcome - based pricing, drug companies will know that payment is coming if the treatment works, and that means more incentive to develop new cures and to find new applications for existing drugs.

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.

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).

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...

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.

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.

His big break came when he got to work on a new - product application for the U.S. Food and Drug Administration.

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.

He says such a tool could be useful for pharmaceutical chemists who want to mix and match chemical building blocks in many ways to search for new drugs — another application the researchers are working on.

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.»

«We explore new drugs, new biochemical pathways, new applications for isotopes.»

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.

In the new study, DrugPredict suggested non-steroidal anti-inflammatory drugs, also known as NSAIDs, could have applications for epithelial ovarian cancer.

Later this year, they'll seek FDA approval for a new cancer drug and request an additional application for Arcalyst, their first product on the market.

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.

Researchers at McGill University have developed a new, low - cost method to build DNA nanotubes block by block — a breakthrough that could help pave the way for scaffolds made from DNA strands to be used in applications such as optical and electronic devices or smart drug - delivery systems.

«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.

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.

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

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.

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.

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 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.

Medical writers produce the documents that help companies push a drug or device from clinical trials through FDA approval, including literature summaries, applications to FDA to investigate a new device or drug, and documents intended for review by institutional review boards (IRBs).

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.

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.

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.

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.

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