Sentences with phrase «therapy product in»

The first approved cell therapy product in Russia brought about $ 0.5 M USD in revenue last year (personal communication with CEO).

Not exact matches

Alder is additionally evaluating ALD1910, a preclinical product candidate also in development as a migraine prevention therapy.

In December, the company introduced a new website, «Retail Therapy,» where products are renamed to match common Google searches in SwedeIn December, the company introduced a new website, «Retail Therapy,» where products are renamed to match common Google searches in Swedein Sweden.

Although the FDA can't dictate prices or reject therapies over pricing concerns (they can only focus on safety and efficacy), the agency can encourage more competition through moves like this (as well as speedier approval pathways) which could spur drug makers to produce products that ultimately lower costs for patients — a goal cited by FDA Commissioner Scott Gottlieb in announcing the list.

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).

Risk Versus Reward: The Value of Cell Therapy for Patients and Investors Source: Streetwise Reports (4/25/18) The cell therapy space, encompassing disruptive new treatment including stem cell therapy, immunotherapy and gene editing, has begun to mature, with a handful of product approvals and others in late - stage develTherapy for Patients and Investors Source: Streetwise Reports (4/25/18) The cell therapy space, encompassing disruptive new treatment including stem cell therapy, immunotherapy and gene editing, has begun to mature, with a handful of product approvals and others in late - stage develtherapy space, encompassing disruptive new treatment including stem cell therapy, immunotherapy and gene editing, has begun to mature, with a handful of product approvals and others in late - stage develtherapy, immunotherapy and gene editing, has begun to mature, with a handful of product approvals and others in late - stage development.

The cell therapy space, encompassing disruptive new treatment including stem cell therapy, immunotherapy and gene editing, has begun to mature, with a handful of product approvals and others in late - stage development.

Elsewhere in the sector, we favor lowly valued biotech firms with innovative pipelines offering products with limited competition or demonstrable advantages over existing therapies.

Of the products and procedures at issue in the mandate debate, at least some do have legitimate therapeutic purposes (e.g., the anovulent pill is sometimes used as a kind of hormone therapy).

As the women heal through the therapy, community, and training offered by the Magdalene program, they offer healing to others through the aromatic bath and body products they make from essential oils and sell in stores and online.

LANSINOH: This company makes amazing products for breastfeeding including some of our favorites: Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Thera Pearl 3 - in - 1 Breast Therapy Packs, and Lansinoh HPA Lanolin.

A leader in compression therapy products, the company uses high - quality synthetic materials to keep your garments functional for longer - and with our huge selection and competitive prices, there's no better place to buy Juzo's casual and fashion - forward products than Discount Surgical Stockings!

In my research to find therapies and equipment to help her develop fully, I came across a product called theratogs.

Compression therapy products are put on in the morning upon arising, which is typically before any significant swelling would occur, and then removed at night.

Another welcome product, Bamboobies Soothing Therapy Pillows can be heated in the microwave and then placed against your chest to assist with letdown and opening painful, clogged ducts — a real life saver!

Our products are designed to use in home, classroom, play therapy settings and more, helping adults connect with, lead and guide children from their center.

If you want to invest in a sturdy and dependable product for your massage therapy business, then you should check out all that the Master Massage Pro Chair has to offer.

In January 2012, a six - year follow - up study of 787 adults who had recently quit smoking found that those who used nicotine replacement therapy in the form of a patch, gum, inhaler or nasal spray had the same long - term relapse rate as those who did not use the productIn January 2012, a six - year follow - up study of 787 adults who had recently quit smoking found that those who used nicotine replacement therapy in the form of a patch, gum, inhaler or nasal spray had the same long - term relapse rate as those who did not use the productin the form of a patch, gum, inhaler or nasal spray had the same long - term relapse rate as those who did not use the products.

Hormone therapy «was always primarily a product to use in women entering menopause,» says Howard Hodis, a physician scientist who focuses on preventive medicine at the University of Southern California's Keck School of Medicine in Los Angeles.

The researchers assessed LPLD - related acute abdominal events that required hospital care in a small group of patients treated with a single dose of the gene therapy product Glybera ®.

New products and developments, such as new drugs for cancer, fresh therapies for rare diseases, progress in medications for HIV / AIDS, and advances in stem cell research had the greatest positive impact.

These include the ability to bring new, innovative products to the market; progress in oncology, such as the approval of Genentech's drug Avastin for breast cancer and advances in the use of gene therapy, despite some setbacks; continuing progress in research on stem cells; the emergence of treatments for previously untreated diseases; and solutions for food and fuel shortages, such as biocrops and biofuels.

China was the first country to approve a gene therapy product for commercial use, in 2004.

Still, a few stem cell therapies have now been approved, such as a treatment available in India that takes stem cells from the patient's eye in order to regrow the surface of their cornea, and a US product based on other people's bone stem cells.

Seven years after Moore's initial therapy, Golde asked his patient to sign a contract relinquishing his rights and those of his heirs to any cell lines or products derived from his blood or tissues (Moore's spleen had been removed in the course of his treatment).

According to the FDA, the use of testosterone therapy has increased significantly, from 1.3 million patients in 2009 to 2.3 million patients who had a prescription for testosterone products in 2013.

The article in the journal Molecular Therapy — Nucleic Acids titled «As Technologies for Nucleotide Therapeutics Mature, Products Emerge» describes the analysis of more than 60,000 research publications related to oligonucleotide therapies.

In an early benefit assessment pursuant to the «Act on the Reform of the Market for Medicinal Products» (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether this new active ingredient offers an added benefit over the appropriate comparator therapIn an early benefit assessment pursuant to the «Act on the Reform of the Market for Medicinal Products» (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether this new active ingredient offers an added benefit over the appropriate comparator therapin Health Care (IQWiG) examined whether this new active ingredient offers an added benefit over the appropriate comparator therapy.

The product, dubbed tisagenlecleucel (pronounced tis - a-gen-LEK-loo-sell), is the first gene therapy of any kind to be approved in the United States.

But they also see cause for hope in new products, therapies, and research undertaken by the industry.

In contrast, applied research needs to contribute to a product or therapy, which means that research projects which don't show potential will be dropped to give attention to more promising ones.

Among the interesting topics covered in Pathways are: the changing role of the patient in the total health equation and the ways in which decentralized information is affecting their expectations and demands; the dearth of pipeline products among international pharmaceutical companies against a backdrop of increased research and development spending; the dynamics of emerging markets and their rising demand for therapies in chronic disease; the value of drugs and biotechnology solutions within the context of global economic realities.

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.

If CTL019 is approved, the Swiss pharmaceutical giant plans to dole it out from about 30 preapproved sites, each trained in the multi-step process of harvesting cells, handling the product, and treating patients for the feverish and often life - threatening immune response that usually accompanies CAR - T therapy.

Commenting on Tong Yuan's treatment for Parkinson's disease, Oliver Cooper, director of the Stem Cell Facility of the Neuroregeneration Institute at McLean Hospital in Belmont, Massachusetts, and a specialist in Parkinson's disease, says, «The products offered by Tong Yuan may provide anecdotal, poorly controlled, transient improvements in the patients, but Parkinson's - disease patients need long - term therapies.»

They do social science, health, philosophical, policy, or legal research on topics such as privacy, confidentiality, the psychological impact of genetic information, informed - consent issues in genomics research, commercialization of genetic products, genetically modified foods, behavioral genetics, gene testing, and gene therapy.

In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) has examined whether this new drug for MS offers an added benefit over the appropriate comparator therapy specified by the Federal Joint Committee (G - BAIn an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) has examined whether this new drug for MS offers an added benefit over the appropriate comparator therapy specified by the Federal Joint Committee (G - BAin Health Care (IQWiG) has examined whether this new drug for MS offers an added benefit over the appropriate comparator therapy specified by the Federal Joint Committee (G - BA).

George notes, «Our goal in this trial was to evaluate the safety of the gene therapy product and secondarily, to determine if we could achieve levels of factor IX that could decrease bleeding events in patients.»

Spark Therapeutics in Philadelphia, Pennsylvania, which is testing the Bennett group's therapy in a phase III clinical trial needed to seek regulatory approval, also maintains that the NEJM results may not be relevant to their product.

Although there are currently no gene therapy products on the market in the U.S., recent studies in both Parkinson's disease and Leber congenital amaurosis, a rare form of blindness, have returned very promising results.

China has made crucial breakthroughs in the field, including creating the world's first commercialized gene therapy product, Gendicine.

Whether it's developing new products that will be manufactured in America, or getting and using energy more sustainably, or improving health care with better therapies and better use of information technology, or providing better protection for our troops abroad and our citizens at home, innovation will be key to our success.

We leverage our cutting - edge platforms to produce product candidates and utilize distinct therapeutic approaches that, we believe, address the shortcomings of existing therapies and have the potential to treat a broad patient population either as individual therapies or in combination with other mechanisms of action.

In the health care industry, many life - saving products, such as recombinant therapeutic proteins, vaccines, and gene therapy vectors, are produced from large - scale cell culture systems.

The PEC - Encap ™ (also known as VC - 01) product candidate is designed to deliver the same pancreatic progenitor cells in an immunoprotective device and is currently in active development as a therapy for all patients with type 1 diabetes as well as insulin requiring patients with type 2 disease.

Caribou Biosciences is pioneering a new era of precision cell engineering and we are seeking talented and passionate individuals to help us in our mission to transform the development of new medical therapies and bio-based products.

ViaCyte's PEC - EncapTM (also known as VC - 01TM) product candidate is the first pluripotent stem cell - derived islet cell replacement therapy for the treatment of type 1 diabetes in clinical - stage development.

At the same time, it's incumbent upon the FDA to make sure that this existing framework is properly defined, with bright lines separating new treatments that are medical products subject to the FDA's regulation from those therapies that are individualized by surgeons in such a way that they are not subject to FDA regulation.

The CBER is already utilizing in silico techniques to predict clinical outcomes and product safety, inform clinical trial designs, and optimize dosing, and is also implementing the Regenerative Medicine Advanced Therapy (RMAT) designation which provides resources to expedite promising regenerative medicines that address unmet needs.

Under his leadership from 2009 - 2015, uniQure received the first - ever approval of a gene therapy product by the European Medicines Agency, built a pipeline of gene therapy products across several disease areas, obtained approximately $ 200M through its NASDAQ - listing and follow - on, and closed a multi-billion dollar collaboration in cardiovascular gene therapy.