Sentences with phrase «accelerated approval for»

In 2009, bevacizumab (Avastin ®) was granted accelerated approval for the treatment of GBM patients whose cancers had recurred, based on results from two phase II studies.

U.S. health regulators on Tuesday granted accelerated approval for Pfizer Inc's immuno - oncology drug Bavencio to treat advanced bladder cancer, marking the second approval in less than two months for the treatment developed along with Germany's Merck KGaA.

At the same time, the authorities in recent months have rolled out a series of tax breaks and accelerated approvals for infrastructure projects.

Among the goals of the pilot program is to identify how to balance local and national concerns regarding UAS integration and accelerating approvals for operations that currently require special authorizations.

Not exact matches

Important factors that could cause actual results to differ materially from those reflected in such forward - looking statements and that should be considered in evaluating our outlook include, but are not limited to, the following: 1) our ability to continue to grow our business and execute our growth strategy, including the timing, execution, and profitability of new and maturing programs; 2) our ability to perform our obligations under our new and maturing commercial, business aircraft, and military development programs, and the related recurring production; 3) our ability to accurately estimate and manage performance, cost, and revenue under our contracts, including our ability to achieve certain cost reductions with respect to the B787 program; 4) margin pressures and the potential for additional forward losses on new and maturing programs; 5) our ability to accommodate, and the cost of accommodating, announced increases in the build rates of certain aircraft; 6) the effect on aircraft demand and build rates of changing customer preferences for business aircraft, including the effect of global economic conditions on the business aircraft market and expanding conflicts or political unrest in the Middle East or Asia; 7) customer cancellations or deferrals as a result of global economic uncertainty or otherwise; 8) the effect of economic conditions in the industries and markets in which we operate in the U.S. and globally and any changes therein, including fluctuations in foreign currency exchange rates; 9) the success and timely execution of key milestones such as the receipt of necessary regulatory approvals, including our ability to obtain in a timely fashion any required regulatory or other third party approvals for the consummation of our announced acquisition of Asco, and customer adherence to their announced schedules; 10) our ability to successfully negotiate, or re-negotiate, future pricing under our supply agreements with Boeing and our other customers; 11) our ability to enter into profitable supply arrangements with additional customers; 12) the ability of all parties to satisfy their performance requirements under existing supply contracts with our two major customers, Boeing and Airbus, and other customers, and the risk of nonpayment by such customers; 13) any adverse impact on Boeing's and Airbus» production of aircraft resulting from cancellations, deferrals, or reduced orders by their customers or from labor disputes, domestic or international hostilities, or acts of terrorism; 14) any adverse impact on the demand for air travel or our operations from the outbreak of diseases or epidemic or pandemic outbreaks; 15) our ability to avoid or recover from cyber-based or other security attacks, information technology failures, or other disruptions; 16) returns on pension plan assets and the impact of future discount rate changes on pension obligations; 17) our ability to borrow additional funds or refinance debt, including our ability to obtain the debt to finance the purchase price for our announced acquisition of Asco on favorable terms or at all; 18) competition from commercial aerospace original equipment manufacturers and other aerostructures suppliers; 19) the effect of governmental laws, such as U.S. export control laws and U.S. and foreign anti-bribery laws such as the Foreign Corrupt Practices Act and the United Kingdom Bribery Act, and environmental laws and agency regulations, both in the U.S. and abroad; 20) the effect of changes in tax law, such as the effect of The Tax Cuts and Jobs Act (the «TCJA») that was enacted on December 22, 2017, and changes to the interpretations of or guidance related thereto, and the Company's ability to accurately calculate and estimate the effect of such changes; 21) any reduction in our credit ratings; 22) our dependence on our suppliers, as well as the cost and availability of raw materials and purchased components; 23) our ability to recruit and retain a critical mass of highly - skilled employees and our relationships with the unions representing many of our employees; 24) spending by the U.S. and other governments on defense; 25) the possibility that our cash flows and our credit facility may not be adequate for our additional capital needs or for payment of interest on, and principal of, our indebtedness; 26) our exposure under our revolving credit facility to higher interest payments should interest rates increase substantially; 27) the effectiveness of any interest rate hedging programs; 28) the effectiveness of our internal control over financial reporting; 29) the outcome or impact of ongoing or future litigation, claims, and regulatory actions; 30) exposure to potential product liability and warranty claims; 31) our ability to effectively assess, manage and integrate acquisitions that we pursue, including our ability to successfully integrate the Asco business and generate synergies and other cost savings; 32) our ability to consummate our announced acquisition of Asco in a timely matter while avoiding any unexpected costs, charges, expenses, adverse changes to business relationships and other business disruptions for ourselves and Asco as a result of the acquisition; 33) our ability to continue selling certain receivables through our supplier financing program; 34) the risks of doing business internationally, including fluctuations in foreign current exchange rates, impositions of tariffs or embargoes, compliance with foreign laws, and domestic and foreign government policies; and 35) our ability to complete the proposed accelerated stock repurchase plan, among other things.

On Thursday, Bristol - Myers Squibb abruptly ditched an accelerated approval application for a combo of its rival immunotherapy Opdivo and an older drug called Yervoy.

Meanwhile, Frayne's applications for accelerated patent approval (due to his medical condition) were approved.

China's regulatory authorities have also recognised these demographics, and are keen on overhauling the drug approval mechanism and accelerating the research and development process for innovative drugs.

The latest indicators of housing prices continue to show strong growth in most areas, and new finance approvals for housing have been accelerating in the past few months.

Rio Tinto is accelerating the development of the Simandou iron ore project in Guinea with the approval of a further US$ 211 million for continued studies and US$ 1.117 billion of funding for commitments for early works and procurement of long - lead items.

It originally received accelerated approval by the FDA in 2015 as a treatment for NSCLC.

The drug, trade named Mylotarg, received accelerated approval from the U.S. Food and Drug Administration in 2000 for treatment of AML in adults.

As the pace of drug approvals accelerates and the U.S. Food and Drug Administration (FDA) faces potential budget cuts, a new research design from Perelman School of Medicine scientists offers a new way to successfully assess safety of newly approved drugs, as well as drugs that have been on the market for a long time and have had a marked rise in their use.

The FDA's accelerated approval regulatory option, for example, is specifically designed to allow FDA validation based on studies measuring «surrogate endpoints.»

The FDA granted accelerated approval to nivolumab (Opdivo), an anti-PD-1 checkpoint inhibitor, for patients with classical Hodgkin lymphoma (cHL) whose disease has relapsed or progressed after stem cell transplantation and the targeted antibody brentuximab vedotin (Adcetris).

The FDA granted accelerated approval to avelumab (Bavencio, EMD Serono, Inc.), a checkpoint immunotherapy that targets the PD - 1 pathway, as a second - line treatment for advanced bladder cancer.

In an effort to drive costs down, provisions of the Obama administration's Affordable Care Act accelerated the approval process for new biologics intended to compete with already approved medicines.

The FDA granted accelerated approval to avelumab (Bavencio, EMD Serono, Inc.), a checkpoint immunotherapy that targets the PD - 1 pathway, as a first - line treatment for a rare form of skin cancer called Merkel cell carcinoma (MCC).

The US Food and Drug Administration granted accelerated approval to avelumab (Bavencio) in May 2017, for the treatment of locally advanced or metastatic urothelial carcinoma patients whose disease progressed on or following platinum - containing chemotherapy.

The FDA granted accelerated approval to pembrolizumab (Keytruda), an anti-PD-1 checkpoint inhibitor, for patients with recurrent or metastatc head and neck squamous cell carcinoma (HNSCC).

The FDA granted accelerated approval to pembrolizumab (Keytruda, Merck) as a second - line treatment for all metastatic solid tumor types classified as MSI - hi (high microsatellite instability) or dMMR (deficient DNA mismatch repair).

The long - term objective is to fully validate and obtain regulatory qualification of biomarkers, which will enable drug developers and the broader Crohn's disease community of clinicians and researchers to accelerate the development and approval of treatments for those living with this disease.

In its approval notice, the department «highlighted several aspects of Arizona's state plan, including the ability of elementary and middle schools to earn additional points in its accountability system for accelerating student achievement.»

2-23-2016 Regular APPROVED Board Meeting Agenda Approval of Minutes 3-13-2015 Board Meeting minutes APPROVED 12-08-2015 Annual Board Meeting minutes APPROVED 12-08-2015 Board Meeting minutes APPROVED President's Report ACES - BOD REPORT FEBRUARY -2016-02-21 Staff Reports Public Records Request Policy Student Record Policy Local Control and Accountability Plan Survey ACES SARC 2014 - 2015 TAS 2014 - 2015 SARC WAHS SARC 2014 - 2015 ACES Safe School Plan Feb 2016 TAS - WAHS Safety Plan 2015 - 2016 LAUSD Compliance Documents ACES 1 Food Service Update - 1-21-2016 ACES 2 Food Service Update - 1-21-2016 TAS WAHS Food Service Update - 1-20-2016 Facilities Update Finance Committee Reports Form 990 & 199 Financial - Statements - for -7-months-ended-1-31-16 FY16 2nd Interim Accelerated Elementary (2013) R FY16 2nd Interim Accelerated Charter (2015) R FY16 2nd Interim Wallis Annenbrg HS (8828) R

If you qualify for accelerated underwriting, you can often bypass the medical exam and be approved in as little as 24 hours, although most people can expect 7 - 10 business days for approval.

Accelerated Hydrogen Peroxide ® (AHP ®) disinfectant technology receives approval for use in the International Space Station.

The company created an accelerated underwriting program for its no medical life insurance policy that cuts down the length of process time and you may get an approval in 2 days or less.

This is a further step in the general direction of accelerated drug approvals, and a major win for industry.