Sentences with phrase «safety data from»

The FAA will use safety data from each phase to ensure appropriate mitigations are in place as small UAS operations are integrated into controlled airspace.

Unsealed court documents indicate that Bayer withheld safety data from the FDA during the approval process for Yasmin.

The approval was supported by two placebo - controlled Phase III clinical studies comparing Fanapt ™ to placebo and active control in patients with schizophrenia, as well as safety data from more than 3,000 patients.

The encouraging safety data from this program and our preclinical and clinical experience in other neurodegenerative diseases support the broadening of our efforts to develop antisense drugs to treat a number of severe neurodegenerative diseases.»

Published new efficacy and safety data from preclinical studies of AST - OPC1 in the peer - reviewed journal «Stem Cells Translational Medicine.»

AST - VAC1 (antigen - presenting autologous dendritic cells) is an autologous cancer immunotherapy with promising efficacy and safety data from a Phase 2 study in Acute Myeloid Leukemia (AML).

Asterias Biotherapeutics, Inc will present new 9 - month efficacy and safety data from their ongoing Phase I / IIa trial for OPC - 1 in a workshop and poster presentation.

The investigators pooled the safety data from the phase I JAVELIN Solid Tumor trial, which included 1,650 patients, and the phase II JAVELIN Merkel trial (88 patients); the agent was also approved in early 2017 for the treatment of metastatic Merkel cell carcinoma.

At the International Society for Stem Cell Research 2017 Annual Meeting (June 14 - 17, 2017; Boston, USA), Asterias Biotherapeutics, Inc (CA, USA) will present new 9 - month efficacy and safety data from their ongoing SCiStar Phase I / IIa trial of human embryonic stem cell - derived oligodendrocyte progenitor cells.

Also, EPA would no longer have to show that a chemical is potentially risky in order for the agency to request new safety data from companies.

The drug has already demonstrated safety in nonhuman primate trials, and the cardiovascular research might even be able to skip ahead to a larger phase II trial based on safety data from the ongoing phase I studies, Leeper suggests.

The documentation ranges across the whole spectrum of drug development: Investigators» brochures provide information on all that is currently known about the medicine and so need periodic updating; accurate and concise protocols are required to ensure that trials are performed effectively; clinical trial reports (generally from phase II and III studies) present the information gathered from the trials; higher level documents provide summaries of efficacy and safety data from clinical trial programmes; expert reports provide critical interpretation of the results; and response documents clarify any points that are not clear to the regulatory agencies or provide additional analyses or supporting data for any items of concern.

CPMs and homebirth advocates are condemning the publication of existing safety data from other studies while REFUSING to release their own safety data.

MANA will only reveal the data to those who can prove they will use it «for the advancementhomebirth advocates are condemning the publication of existing safety data from other studies while REFUSING to release their own safety data.

Evidently, they are taking a page out of the playbook of the Midwives Alliance of North America (MANA), the organization that represents homebirth midwives, who conducted a publicly announced collection of safety data from 24,000 planned homebirths and now are hiding how many deaths occurred at the hands of homebirth midwives.

Not exact matches

The notes, which were photographed as one of his aides closed the binder during a short break from testifying, were extensive and covered issues of data scraping, data safety, and matters surrounding disturbing content on the platform, as well as broader issues of diversity, competition, Facebook's business model, Apple's business model, and «Election Integrity (Russia).»

Looking at data from the US Consumer Product Safety Commission's National Electronic Injury Surveillance System, there's a noticeable spike around Independence Day.

These odds above are based on a previous analysis by Business Insider, and the data primarily come from a 2016 report by the National Safety Council and the National Center for Health Statistics» final 2013 report on causes of death in the US, which was released in February 2016.

Analyzing data from the National Highway Traffic Safety Administration's Fatality Analysis Reporting System, the authors determined that Uber is responsible for a 16.6 percent decline in vehicular fatalities each year.

We then use that to build out two additional scenarios: one assuming a doubling of the current minimum wage plus factoring in the cost of fire and building safety improvements based on data from the Worker Rights Consortium; and another using a «living wage» figure from the East Asia labour organization Asia Floor Wage, which is considered at the high end of labour reform demands.

It comes on top of a separate 2017 initiative from the company that gave drivers access to data about their speeding and braking habits, in hopes of boosting safety.

Safety experts point to the numbers: U.S. pedestrian deaths have been on the rise, with 5,376 in 2015 and nearly 6,000 last year, the most in two decades and up 22 percent from 2014, according to data compiled by the Governors Highway Safety Association for a recent report.

Actual results and the timing of events could differ materially from those anticipated in the forward - looking statements due to these risks and uncertainties as well as other factors, which include, without limitation: the uncertain timing of, and risks relating to, the executive search process; risks related to the potential failure of eptinezumab to demonstrate safety and efficacy in clinical testing; Alder's ability to conduct clinical trials and studies of eptinezumab sufficient to achieve a positive completion; the availability of data at the expected times; the clinical, therapeutic and commercial value of eptinezumab; risks and uncertainties related to regulatory application, review and approval processes and Alder's compliance with applicable legal and regulatory requirements; risks and uncertainties relating to the manufacture of eptinezumab; Alder's ability to obtain and protect intellectual property rights, and operate without infringing on the intellectual property rights of others; the uncertain timing and level of expenses associated with Alder's development and commercialization activities; the sufficiency of Alder's capital and other resources; market competition; changes in economic and business conditions; and other factors discussed under the caption «Risk Factors» in Alder's Annual Report on Form 10 - K for the fiscal year ended December 31, 2017, which was filed with the Securities and Exchange Commission (SEC) on February 26, 2018, and is available on the SEC's website at www.sec.gov.

According to data collected by the National Highway Traffic and Safety Administration, approximately 11,506 people, which includes 6,300 suspects, have been killed during police chases in the U.S. from 1979 through 2013.

The data primarily come from a 2017 report by the National Safety Council and a National Center for Health Statistics» report on causes of death in the US for 2014.

As activists from around the country gather in Washington to march for gun safety regulation, new data shows that the National Rifle Association has been aggressively resisting their message through online ads.

However, a Reuters analysis of nationwide bridge data reveals the fretting over the safety of bridges and other road infrastructure is overblown and could distract from more serious problems elsewhere:

«What we see is that customers who have higher data plans use more data and are the customers that really are the ones that can benefit from things like safety mode,» she said.

China's National Nuclear Safety Administration said data from radiation monitoring stations near the North Korean border showed no impact on «China's environment or populace».

Tesla also claims the U.S. government found a year ago that Autopilot reduced crash rates by 40 percent, a characterization of data from a National Highway Traffic Safety Administration report that some safety experts call misleSafety Administration report that some safety experts call mislesafety experts call misleading.

In 2017, the National Highway Traffic Safety Administration closed a probe into a May 2016 fatal crash involving a driver using the system and cited data from the automaker that crash rates fell by 40 percent after installation of Autopilot's Autosteer function.

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).

An upcoming platform combining two of the X1 chips can process data collected from up to 12 high - definition cameras monitoring traffic, blind spots and other safety conditions in driver assistance systems, Huang said.

Ensuring the safety and security of payment systems data is essential to reduce the risks from data breaches while maintaining a healthy pace of growth in digital payments, the RBI said.

Presentations will highlight the short and long - term effects of Ingrezza on tardive dyskinesia symptoms by body region, long term safety and efficacy data from the KINECT 4 phase 3 open label study and also from RE-KINECT (real - world screening study of patients with possible TD).

In a March 16 research note, Andrew Fein, an analyst at H.C. Wainwright & Co., reported that OvaScience (OVAS: NASDAQ) shifted its focus back to research and development, after interim data from the first 20 patients in its Phase 1 trial of OvaPrime showed no signs of efficacy despite indicating safety and tolerability.

Using data compiled from records of the USDA Food Safety and Inspection Service and the US Food and Drug Administration, the ERS reports...

Collectively, the data presented in these application submissions have not identified potential health and safety concerns, and support the conclusion that food and / or livestock animal feed derived from provitamin A biofortified GR2E rice is as safe and nutritious as food or feed derived from conventional rice varieties.

Using data compiled from records of the USDA Food Safety and Inspection Service and the US Food and Drug Administration, the ERS reports food product recalls increased significantly from 2004...

A technical briefing focused on event selection, nutritional impact, safety assessment and agronomic data from the GR2E Golden Rice confined field trials in Bangladesh.

We assessed the data and from there developed a software tool that predicts the microbiological safety and stability of new formulations of shelf stable mayonnaises and dressings with reduced or alternative food acids, based on the company's own systems and processes.

For instance, a vegan restaurant might not utilize a deep fryer but they can certainly collect and utilize data from refrigerators and ovens to ensure adherence to food safety standards.

Insideworldfootball data is taken from the official stadium capacities and the official reported attendances and does not take any account for seat kills for media or safety reasons.

A new Amazon - backed US study from Washington - based international nonprofit Family Online Safety Institute (FOSI) has found that 70 % of parents are comfortable with their child having a connected device or toy, but data privacy and safety guidelines are still an essential piece of the pSafety Institute (FOSI) has found that 70 % of parents are comfortable with their child having a connected device or toy, but data privacy and safety guidelines are still an essential piece of the psafety guidelines are still an essential piece of the puzzle.

In addition, at this time, the Baby - Friendly Hospital Initiative has produced no data on the safety of newborn fasting and weight loss caused by exclusive colostrum feeding and what degree of weight loss protects a child from brain - threatening complications like hyperbilirubinemia, hypernatremic dehydration and hypoglycemia.

That book is full of misinformation, for example he cites the Johnson & Daviss study saying «any remaing doubts about the safety of home birth were conclusively erased» by said study — which isn't even remotely true (the home birth data from that study actually shows that neonatal mortality is 3 TIMES higher at home):

RCOG's position statement on water birth is from 2006, and it basically admits there was very little to no reliable safety data on the subject, but that there were anecdotal reports of drowning and infection.

The event convenes leaders from industry, government, academics and NGOs to focus on online safety, privacy issues and data protection.

The brief includes the analysis of survey data from program participants on child safety in the home, observed parenting practices, parental stress and parenting efficacy, self - reported parenting practices, and rates of child maltreatment.

Nearly 50,000 kids each year visit the emergency room after being injured on home playground equipment, according to data from the U.S. Consumer Product Safety Commission.