The company had identified a molecule, CGP3466B, that in laboratory tests protected neurons from degeneration by inhibiting apoptosis, and had tested
it in clinical trials on patients with Parkinson's disease and amyotrophic lateral sclerosis, or ALS.
For the first time, a team of Chinese scientists will use the CRISPR - Cas9 gene editing technique
in a clinical trial on lung cancer patients.
Not exact matches
Freenome, a liquid biopsy startup that's looking to enter
clinical trials, is working
on technology that would be able to detect cancer
in the body, including its location and type, using only blood samples.
In December, Tehrani signed a deal with GlaxoSmithKline that will allow the pharmaceutical giant to test at least four of its drug candidates
on a Zymeworks - designed platform, which combines a computer simulation with a way of engineering protein molecules and allows products to be refined before they move to expensive
clinical trials.
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.
«Watson is able to give us faster, better matching of patients to potential
clinical trials that our oncologists wouldn't have otherwise be able to see — and I sit with our oncologists who work
on this kind of thing,» Christopher Ross, CIO at the Mayo Clinic, told MobiHealthNews
in an interview.
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.
With a critical mass of 450,000 patients annually among them, the six centers have agreed to combine their efforts
on planning
clinical trials in immunotherapy, recruit patients quickly, and share the information learned — which could be the single biggest factor
in speeding up drug development.
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.
That provision would have allowed approved drugs that win additional FDA clearances to treat rare disorders — i.e., those that affect 200,000 or fewer Americans — extended market exclusivity
in the hopes that biopharma companies would be more compelled to invest
in difficult - to - treat spaces that involve costly follow -
on clinical trials.
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.
It had originally registered the
clinical trial in a U.S. government database as «The Effects of SPRINT, a Combination of Natural Ingredients,
on Cognition
in Healthy Young Volunteer.»
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.
Researchers from the Sichuan University
in Chengdu inserted the re-engineered cells into a lung cancer patient participating
in a
clinical trial at the West China Hospital
on October 28th, according to Nature.
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.
On average about 99 % of all drugs
in clinical trials never actually make it to approval, and drugs are still failing late - stage
trials in 2017.
There are about 120 studies ongoing
in Israel, including
clinical trials looking at the effects of cannabis
on autism, epilepsy, psoriasis, and tinnitus.
As we explained
in our ASCO primer, pharma giants like Merck (mrk) and Bristol - Myers Squibb (bmy) and biotechs like Juno (juno) and Kite Pharma (kite) had a lot to prove through their
clinical trial updates
on experimental immunotherapies.
Solanezumab, a drug developed by Eli Lilly that also acts
on the amyloid hypothesis, failed some key
clinical trials, though the company is still testing it
in the pre-
clinical stages of the disease.
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).
HERERA: Merck (NYSE: MRK) was one of the best performing stocks
on the blue chip Dow index today, after the drug company «s new type of lung cancer drug performed better than expected
in a highly anticipated
clinical trial.
Additional
clinical trial data later this year
on Tesaro's key drug, Niraparib, which targets advanced solid tumors
in ovarian and breast cancers, could help narrow the valuation gap, the people said.
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.
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.
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.
In 2000 - 10 roughly 80,000 patients took part in clinical trials based on research that was later retracted because of mistakes or improprietie
In 2000 - 10 roughly 80,000 patients took part
in clinical trials based on research that was later retracted because of mistakes or improprietie
in clinical trials based
on research that was later retracted because of mistakes or improprieties.
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.
We may be subject to different or contradictory regulatory requirements
in different countries, and different regulatory authorities may not be aligned
on the
clinical trials necessary to support approval of our product candidates.
And the San Francisco Chronicle reports that over 100
clinical trials listed
on the ClinicalTrials.gov website feature Fitbit trackers
in addition to those
trials using the Apple Watch, Jawbone, Garmin, Pebble and other devices.
That's because it costs
on average, $ 1.2 billion dollars to bring a new drug to market — from the time it is a twinkle
in a scientist's eye, through a decade or more of lab research, to
clinical trials and finally FDA approval.
A March 28, 2018, research note by JMP Securities analyst Michael King indicated that at the recent International Symposium
on Amyloidosis
in Japan, Alnylam Pharmaceuticals Inc. (ALNY: NASDAQ) reported multiple sets of results of
clinical trials, separately evaluating its investigational RNA interference (RNAi) therapeutics patisiran and ALN - TTRsc02.
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.
On the heels of a 2013 double - blind
clinical trial which showed Axiom Foods» Oryzatein ® plant - based brown rice protein parallels animal - based whey
in building and repairing muscle, Oryzatein ® has now become the very first brown rice protein to be granted GRAS approval.
With China expected to experience rapid growth
in clinical trials over the short term, the Australian industry needs to remain competitive by focusing
on quality factors as a differentiator.
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.»
The 2nd International Congress
on Advances
in Food Chemistry and Technology will exhibit the products and services from commercial and non-commercial organizations like Drug manufactures,
Clinical Trial Sites, Management Consultants, Chemists, Pharmacists, Business delegates and Equipment Manufacturers.
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.
(Culver City, CA April 8, 2014)--
On the heels of a 2013 double - blind
clinical trial which proved Axiom Food's Oryzatein ® plant - based brown rice protein equals animal - based whey
in building and repairing muscles, Oryzatein has now become the very first brown rice protein to be granted GRAS approval.
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.
He has published seminal works
on blood pressure management through his role
in the BPLTTC and played leading roles
in a series of
trials that define the
clinical management of patients with diabetes and chronic kidney disease.
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.
Before the sack, Richardson's performance against Clowney is an offer any NFL GM would spend first - round money
on: when applied
on roughly one - third of called offensive plays
in a single game, Tiny Richardson can nullify a premier pass - rushing defensive end with single coverage with a 95.4 percent success rate
in clinical trials.
With a recent
clinical trial showing a 110 % improvement
in skin elasticity
in just 8 weeks, Osmosis Pür Medical Skincare's Catalyst AC - 11 DNA Repair Serum is now one of the most powerful age reversing serums
on the market right now.
«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.
The effect of topical virgin coconut oil
on SCORAD index, transepidermal water loss, and skincapacitance
in mild to moderate pediatric atopic dermatitis: a randomized, double - blind,
clinical trial.
She visits OBGYN, perinatal, urology, family practice and internal medicine offices to educate them
on The Fertility Center of Las Vegas by providing information
on the practice, advances
in reproductive endocrinology and infertility, new
clinical trial research, success rates and other important information.
In my experience, there actually are NDs whose care is rooted in science - and evidence - based medicine, and who base their recommendations on scientific studies and clinical trial
In my experience, there actually are NDs whose care is rooted
in science - and evidence - based medicine, and who base their recommendations on scientific studies and clinical trial
in science - and evidence - based medicine, and who base their recommendations
on scientific studies and
clinical trials.
Because the
trial found no differences
in the effect of type of care
on any primary
clinical outcome, the economic analysis compares only the costs of care rather than their cost - effectiveness.