Not exact matches
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).
The feature - rich Easypack ® Quantum ™ XTW offers high productivity, ease - of - use,
safety, superior ergonomics, paper - loading ease, as well as, flexible design
which enables customized work
cell options.
It features safe
cell impact protection
which is and integrated of
safety components that ensure protection for your child.
In this pilot study to test the
safety of putting iPS - derived
cells into humans, the six are all receiving a graft of new retinal pigment epithelial
cells,
which serve to maintain the eye's light - sensing
cells.
The proposed clinical trial, in
which researchers would use CRISPR to engineer immune
cells to fight cancer, won approval from the Recombinant DNA Advisory Committee (RAC) at the U.S. National Institutes of Health, a panel that has traditionally vetted the
safety and ethics of gene therapy trials funded by the U.S. government and others.
Kirschstein worked on another aspect of vaccine
safety, doing «very prominent» early research on another virus, simian virus 40,
which contaminated some of the monkey
cells used to grow poliovirus for the Salk vaccine, says Singer, who later joined the same field.
As an additional
safety feature, the researchers introduced two mutations that weakened the virus's ability to combat the
cell's defenses against infection, reasoning that the mutated virus still would be able to grow in tumor
cells —
which have a poor antiviral defense system — but would be eliminated quickly in healthy
cells with a robust antiviral response.
On «the lack of quality controls on
cells,»
which makes the treatment hard to replicate, thus not guaranteeing
safety and efficacy of the product
The company had initially submitted its request to begin human trials with its RPE
cells in November 2009, but has spent the past year addressing the FDA's concerns about the
safety of the embryonic stem from
which the RPE
cells are made.
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.
Another
safety net is our own immune system,
which can recognize antigens on cancerous
cells and eliminate them from the body.
The positive
safety profile to date, the evidence supporting engraftment of the
cells post-implantation, and the improvements we are seeing in upper extremity motor function highlight the promising findings coming from this Phase 1 / 2a clinical trial,
which will guide us as we work to design future studies.
Okyanos closely follows the adult stem
cell treatment protocols as laid out in clinical trials
which have demonstrated
safety and promising outcomes.
However, the industry appears to favor
cells adapted to suspension cultures (e.g., HEK293),
which can successfully grow in serum - free media and thus provide a heightened
safety profile and reduced cost of goods (CoG)(33).
Overall, SR - Tiget represents a multi-disciplinary research environment,
which provides a unique blend of scientific expertise in the development of innovative gene and
cell therapy strategies, access to relevant preclinical models to evaluate their efficacy and
safety, as well as competence in conducting early phase clinical trials.
Twelve patients with Stargardt's Macular Dystrophy,
which causes vision loss in children after the age of ten, will be enrolled in the combined Phase I / II (
safety and effectiveness) clinical trial, announced Advanced
Cell Technology of Marlborough, Mass..
Their research focused on evaluating the
safety and efficacy of autologous bone marrow - derived stem
cell transplantation in individuals with type 2 diabetes with good glycemic control as well,
which emerged as an important aspect in the transplantation group as well as in the non-transplanted group.
«Given the numerous health benefits, its participation in important intracellular biochemical pathways, normal physiological presence in our
cells,» and tissues, and blood, and «the levels of
which fluctuate with intake, epidemiologic [al] correlates of phytate deficiency with disease and reversal of those conditions [with] adequate intake, and
safety — all strongly suggest for [phytate's] inclusion as an essential nutrient,... perhaps a vitamin.
Specific
safety concerns include: (1) Lithium batteries pose both a chemical and electrical hazard — under certain conditions they can overheat and ignite and, once ignited, can be especially difficult to extinguish; (2) the potential for propagation of thermal runaway between
cells or batteries in a package and between adjacent packages of batteries; (3) the potential for uncontrolled lithium battery fires to overwhelm the capability of existing aircraft cargo fire protection systems, leading to a catastrophic failure of the airframe; and (4) the potential for venting of combustible gases from lithium ion
cells in thermal runaway,
which could collect in an enclosed environment and cause an explosion even in the presence of a suppression agent.
On top of high passive
safety levels — thanks in part to a passenger
cell made from high - and ultra-high strength steels — active
safety features include the Automatic Post-Collision Braking system,
which automatically applies the vehicle brakes after an accident to reduce the chances of a second impact; the pre-crash system,
which tensions seatbelts and closes windows and the sunroof if an accident is likely to improve the effectiveness of the airbags; Front Assist,
which warns the driver in the event of coming too close to the vehicle in front, can prime the brakes, and operates at speeds of up to 99 mph; City Emergency Braking,
which can automatically brake the vehicle at speeds below 18 mph; Automatic Distance Control, a radar - operated cruise control that maintains a set distance from the vehicle in front; and seven airbags as standard, including one for the driver's knees.
The optimised steel structure of the Range Rover Evoque protects occupants using an incredibly strong and stable
safety cell,
which is complemented by a comprehensive system of airbags and restraints.
The Equinox Fuel
Cell includes
safety features such as ABS, traction control system, and GM's OnStar telematics service,
which offers drivers advice on operating the cars as well as information on nearby hydrogen filling stations.
[17] The results from the test were helped by the use of high - strength steel used in the body shell
which was designed to spread crash forces over distinct load channels, therefore ensuring the
safety of the occupants within the
safety cell.
For the rest of us, Hyundai did a good job at Geneva with a wide range of offerings, from the Le Fil Rouge concept that showcases the company's next design language, through the Santa Fe midsize SUV —
which may have the industry's best array of standard
safety features, including blind spot detection — through extensions of the line such as the electric Kona and Nexo second - generation fuel
cell vehicle.
Engine choices include the company's 70 HP (52 kW) plant and the 83 HP (62 kW) unit, and some of the features that make this car a «special edition» include the two - tone colour scheme
which combines the red painted tridion
safety cell with the rest of the car's exterior
which is painted black, plus the 15 - inch alloy wheels also featuring a brilliant black finish.
The Altea XL's structure has been developed as a
safety cell, with an architecture
which channels the introduction of force flows in a calculated way.
As in other Mercedes models, for a limited period of time, Mercedes will offer a special edition named Edition 1,
which could be identified by exclusive design features such as a tridion
safety cell in lava orange, combined with bodypanels / body in white on the fortwo and graphite grey on the forfour.
Carbon fiber isn't necessarily replacing the metal in the 7 - Series, but acts as bracing and an energy deflector all over the
safety cell,
which allows BMW to use less of the heavier steels and more lightweight aluminum throughout the car.
These passive
safety technologies are fully grounded in a state - of - the - art body structure,
which includes deformable zones, occupant protection
cell and three - way load distribution technology.
In fact, crumple zones are typically located in front of and behind the main body of the car (
which forms a rigid «
safety cell»), compacting within the space of the engine compartment or boot / trunk.
«A well - hydrated dog and / or cat ensures that their
cells and organs have the opportunity to function at their highest,» says Matt Koss, president and founder of the company,
which prides itself on its edible - grade ingredients and steadfast commitment to food
safety and transparency.
Following the accident,
which injured 11 students, the National Transportation
Safety Board (NTSB) recommended a ban on
cell phone use for bus drivers.
the refugees flowing into Europe have been using their
cell phones to communicate and exchange information about where to find shelter and
safety,
which borders are
Based on reports from UNHCR, CCR and other organizations, the refugees flowing into Europe have been using their
cell phones to communicate and exchange information about where to find shelter and
safety,
which borders are... [more]
the refugees flowing into Europe have been using their
cell phones to communicate and exchange information about where to find shelter and
safety,
which borders are accessible and to maintain contact with family and friends.
A couple of the most important California traffic
safety tips are «Click It or Ticket» and «It's Not Worth It,»
which encourage drivers to buckle up and put down their
cell phones.
The device sports a 3,300 mAh
cell — smaller than the Galaxy Note 7 and Galaxy S8 + —
which has not only been subjected to its rigorous in - house eight - point battery
safety check, but also put through its paces by a third - party company.
Thanks to Reema Rattan for providing this summary,
which covers articles about the
safety of vitamin supplements, health financing, humane approaches to preventing crime, disability services, ghostwriting of research articles, patenting of stem
cell inventions, and the latest legal developments in the Vioxx case.