Sentences with phrase «on clinical trials for»

Athenex, which raised $ 68 million from a secondary stock offering during the quarter, finished the year with $ 51 million in cash and short - term investments, down from $ 69 million in September as the company spent heavily on clinical trials for the drugs it is developing and absorbed higher licensing fees at its specialty drug business, which has added 12 new drugs to its stable of products.

Not exact matches

Following a devastating clinical trial setback earlier this month for its lead experimental product, a cannabidiol gel, in epilepsy, the firm reported another trial failure on Monday for the product in treating knee pain due to osteoarthritis.

The striking example I focused on then was the cancer drug Avastin, developed by Genentech (now Roche)-- which, at the time, had been studied in at least 400 completed human clinical trials for various cancers.

The latest clinical trial outsourcing / drug development and manufacturing merger hit on Monday as scientific instrument giant Thermo Fisher announced it would buy drug ingredients maker Patheon for $ 5.2 billion ($ 7.2 billion is you count $ 2 billion in net debt).

Shares of cancer - focused biotech Clovis Oncology soared nearly 50 % in early Monday trading on the strength of clinical trial results for its ovarian cancer treatment Rubraca.

The approval was based on two clinical trials of the device and lowers the barrier of entry for other similar devices, by establishing criteria that classify these systems as moderate risk medical devices, the FDA announced.

These risks and uncertainties include, among others: the unfavorable outcome of litigation, including so - called «Paragraph IV» litigation and other patent litigation, related to any of our products or products using our proprietary technologies, which may lead to competition from generic drug manufacturers; data from clinical trials may be interpreted by the FDA in different ways than we interpret it; the FDA may not agree with our regulatory approval strategies or components of our filings for our products, including our clinical trial designs, conduct and methodologies and, for ALKS 5461, evidence of efficacy and adequacy of bridging to buprenorphine; clinical development activities may not be completed on time or at all; the results of our clinical development activities may not be positive, or predictive of real - world results or of results in subsequent clinical trials; regulatory submissions may not occur or be submitted in a timely manner; the company and its licensees may not be able to continue to successfully commercialize their products; there may be a reduction in payment rate or reimbursement for the company's products or an increase in the company's financial obligations to governmental payers; the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company's products; the company's products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading «Risk Factors» in the company's most recent Annual Report on Form 10 - K and in subsequent filings made by the company with the U.S. Securities and Exchange Commission («SEC»), which are available on the SEC's website at www.sec.gov.

And Marathon barely did any actual clinical legwork to get the drug cleared for Duchenne — it relied on 1990 - era clinical trial data before tacking on just enough study material to win an approval that doesn't even address the root cause of the disease.

But while thousands of clinical trials on immunotherapy drugs, of which many are predicted to fail, are springing up, the depth of information on neoantigen vaccines is much shallower: Just two studies on neoantigen vaccines for melanoma, recently profiled in Nature, were completed last year in Boston and Germany.

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.

The biotech plans to shed 20 % of its nearly 600 employees in order to secure yearly cost - savings of about $ 21 million — money which can then be used to double down on late - stage clinical trials for its experimental Parkinson's drug.

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).

* MEDICINES360 AND ALLERGAN PRESENT 5 - YEAR TRIAL DATA FROM LARGEST ON - GOING IUS CLINICAL STUDY Source text for Eikon: Further company coverage:

After Abbott, he co-founded DCVC company BlueTalon, which was initially focused on enterprise data security for data - driven clinical trial design and population health management.

The Blockchain for Clinical Trials Forum will take place on February 12 at the Orlando Science Center in Florida and will bring together prominent healthcare industry stakeholders.

The flagship drug of San Diego's MediciNova failed a midstage clinical trial for methamphetamine dependency, casting doubt on prospects for a product it has placed great hopes in.

Juno asserted that the clinical hold on the ROCKET trial did not affect plans for its other CD19 - directed CAR T - cell product candidates, including JCAR017, for which the company has launched two clinical trials now recruiting patients.

For the second time in 5 months, Juno Therapeutics has put a clinical hold on a Phase II trial of JCAR015 in adult patients with relapsed or refractory B - cell acute lymphoblastic leukemia due to patient deaths.

Juno Therapeutics is seeking to change the protocol for the Phase II ROCKET clinical trial of its acute lymphoblastic leukemia candidate JCAR015, which the FDA has placed on clinical hold following the deaths of three patients, two of them last week.

Pharmaceuticals: Reflects Canada's existing regimes, systems and laws on: patent linkage; protection for clinical trial data; and early working exceptions.

Motif has successfully concluded a second phase III clinical trial on its lead drug, iclaprim and is preparing for regulatory...

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.

Most biotechs would have shuttered a clinical program that showed absolutely no efficacy whatsoever in a late - stage trial, but Novavax has instead doubled down on RSV by going forth with its phase 3 trial of the RSV F vaccine for infants via maternal immunization, and begun planning for another trial in older adults that's reportedly on track to kick off in 2018.

In this randomized, double - blind clinical trial, virgin coconut oil was the clear winner: «among pediatric patients with mild to moderate AD, topical application of virgin coconut oil for eight weeks was superior to that of mineral oil based on clinical (SCORAD) and instrumental (TEWL, skin capacitance) assessments.»

Some thoughts on new treatments being investigated for Coeliac Disease, and the clinical trials required to bring them to market.

Additionally, in a clinical trial Axiom's signature, hexane - free and non-GMO Oryzatein ® rice protein, showed that plant - based rice protein rivals dairy - based whey for muscle building, fat reduction and muscle repair on March 9, 2013.

The study comes on the heels of a 2013 clinical trial that showed rice protein paralleled whey protein in its ability to build muscle and improve strength and power for the first time.

Although a considerable body of scientific evidence substantiates the positive correlation between curcumin consumption and a reduction in the risk of cancer, the paucity of suitably designed human clinical trials that clearly demonstrate any direct effect of curcumin on cancer markers may prevent Health Canada from approving a cancer risk reduction claim for curcumin within the current regulatory framework.

«There's more emphasis now and there will be more emphasis because of the Affordable Care Act [on] offering mental health services in primary care settings,» suggests Curry, who is about to start a clinical trial looking at the effects of cognitive behavior therapy for adolescents with depression and substance abuse problems.

Collectively, the evidence from longitudinal research, clinical trials, and neurodevelopmental research is beginning to provide a compelling case for the view that breastfeeding may have longer - term effects on individual cognitive ability and educational achievement.

Philips Avent has been a reliable household brand since 1984, and the company relies on research and clinical trials to create and enhance their products to deliver the most satisfactory results for your child.

The widespread assumption of safety has led researchers in fetal behaviour to assure women volunteering for clinical trials that ultrasound exposure of one to one - and - a-half hours (sometimes on more than one occasion) is safe for their unborn babies - yet we know of no follow - up of these exposed children.

Although some SIDS experts and policy - makers endorse pacifier use recommendations that are similar to those of the AAP, 272,273 concerns about possible deleterious effects of pacifier use have prevented others from making a recommendation for pacifier use as a risk reduction strategy.274 Although several observational studies275, — , 277 have found a correlation between pacifiers and reduced breastfeeding duration, the results of well - designed randomized clinical trials indicated that pacifiers do not seem to cause shortened breastfeeding duration for term and preterm infants.278, 279 The authors of 1 study reported a small deleterious effect of early pacifier introduction (2 — 5 days after birth) on exclusive breastfeeding at 1 month of age and on overall breastfeeding duration (defined as any breastfeeding), but early pacifier use did not adversely affect exclusive breastfeeding duration.

While anecdotal and clinical experience supports improvement in milk production for women with insulin resistance who start or resume metformin, Vanky and colleagues (Vanky, Nordskar, Leithe, Hjorth - Hansen, Martinussen, & Carlsen, 2012) reported after a randomized, controlled trial that metformin had no effect on breast changes / size increase in pregnancy or breastfeeding in women who were obese.

Shares plummeted Tuesday by more than 90 percent on a failed clinical trial for its multiple sclerosis treatment.

Glenis herself had received an award for her work on encouraging medical research and transparency of clinical trial results.

He serves on the House Energy and Commerce Committee's Health Subcommittee, and last year he authored a section of important health legislation that speeds the process for new drugs to be approved through clinical trials.

The FDA reviews more liver health data and approves duloxetine for depression and diabetic neuropathy (pain), based on another set of clinical trials.

«When they brought me on board, the need was for production capability for clinical trials.

Fiers discovered a key protein on the influenza virus that could serve as a target for a universal vaccine; the drug has shown promise in an early clinical trial.

AveXis, Inc., a clinical - stage gene therapy company developing treatments for patients suffering from rare and life - threatening neurological genetic diseases, announced in July 2016 that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for the treatment based on preliminary clinical results from the trial of AVXS - 101.

Lanza says that this time, he aims to do things right: direct good science focused on treating disease, publish in reputable journals with rigorous peer - review processes and work with high - quality collaborators and clinical centres for its trials.

Also, FDA clears the party drug ecstasy for post-traumatic stress disorder clinical trials, and U.S. courts rule that the federal government must consider the impacts of major energy projects on climate change.

«Our results indicate it is a promising agent for clinical trials, and a as an add - on to more conventional therapies, to prevent tumour recurrence, further disease progression and metastasis.»

GTC recognized the need to demonstrate on its own the potential for the technology and, in the late 1990s, began a clinical trial of human antithrombin for patients undergoing bypass surgery who develop resistance to the anticoagulant drug heparin.

Clinical trials for targeted therapies, selected on the basis of the genomic tests, are scheduled to begin in early 2007.

The result will be corresponding data representations for clinical and trial data, both based on the RIM.

In the newly reconstituted Scientific Responsibility, Human Rights, and Law Program, the missions of the CSFR and NCLS continue to complement one another as staff pursue projects such as continuing seminars for judges on neuroscience and the law, personalized medicine, the state and future of clinical trials, advocacy in science, understanding responsible research practices in changing research environments, and joint AAAS - China Association of Science and Technology workshops on science and ethics.

The team is now calling for a much larger clinical trial, involving one quarter of a million women, to investigate the effect of the screening using HPV testing on cancer rates.

The company hopes that early next year it will initiate clinical trials on product safety, which will pave the way for human efficacy testing that could be completed by 2011.