Sentences with phrase «clinical trial»

A single clinical trial could cost as much as $ 100 million, and the FDA usually approves about one in 10 clinically tested drugs.

Sirona now awaits approval from the China Food and Drug Administration (CFDA), which will lead to a clinical trial of the company's SGLT2 inhibitor for diabetes.

Because you have already factored in risk by applying the clinical trial probability of success, you do not need to include development risk in the discount rate.

Generally speaking, you should only include those drugs that are already in one of the three clinical trial stages.

The clinical trial, referred to as Capita, showed that Prevenar 13 prevented community - acquired pneumonia in the elderly subjects.

CB - 1158 is being tested in a Phase I clinical trial in patients with solid tumors.»

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

Pharmasset's oral drug is called R7128, and recently showed very favorable results from a four - week clinical trial.

Preveceutical said in a release that Australia's specialized hospitals with strong clinical trial capabilities as well as the country's diverse...

What had been a promising US$ 1 billion market cap company prior to announcement of the clinical trial results was worth around US$ 260 million when the dust settled, roughly equivalent to the value of its cash and liquid securities holdings.

Spectrum Pharmaceuticals stock soared 42 % after the company released an update from a promising clinical trial.

Katherine High, Spark's president and chief scientific officer, expressed her enthusiasm for the early clinical data related to SPK - 8011: «The encouraging start of our SPK - 8011 clinical trial reinforces the strength of our gene therapy platform, delivers human proof - of - concept in a second liver - mediated disease — a significant achievement in the gene therapy field — and positions us well to potentially transform the current treatment approach for this life - altering disease with a one - time intervention.»

The fund is offered by BioShares alongside launched a sister fund, BBC, which targets biotech firms in the clinical trial stage.

Seventy - eight obese members of the Israeli Police Force took part in a 6 - month randomized clinical trial.

For Kite Medical Information, Clinical Trial Inquires, Adverse Reactions, and Product Complaints contact: (844) 454 - KITE

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.

To achieve this goal, several approaches are envisaged: identifying small populations with severe disease where a medicine's benefit - risk balance could be favorable; making more use of real - world data where appropriate to support clinical trial data; and involving health technology assessment bodies early in development to increase the chance that medicines will be recommended for payment and ultimately covered by national healthcare systems.

Juno Therapeutics will resume its Phase II ROCKET clinical trial of its acute lymphoblastic leukemia candidate JCAR015 following the FDA's lifting of a partial clinical hold imposed last week following the deaths of three patients.

The results of another clinical trial published in the journal found that high - dose vitamins and minerals did not protect heart attack patients 50 and older from experiencing additional cardiovascular events, though the research was marred by a high dropout rate.

These competitors also compete with us in recruiting and retaining top qualified scientific and management personnel and establishing clinical trial sites and patient registration for clinical trials.

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.

Earlier in his career, he started two companies, an early web catalog provider and a clinical trial software company.

A stroke drug invented at The Scripps Research Institute has shown signs of safety and efficacy in a mid-stage clinical trial.

Cambridge, MA — March 30, 2017 — Aura Biosciences, a biotechnology company developing a new class of therapies to target and selectively destroy cancer cells using viral nanoparticle conjugates, announced today that it has enrolled and dosed the first patient in its Phase 1b clinical trial of light - activated AU - 011, an investigational, first - in - class targeted therapy in development for the treatment of ocular melanoma, a rare and life - threatening disease.

REINVENTING THE CLINICAL TRIAL Research Track Traditional clinical trials ask one question: Does an experimental treatment work better than nothing at all — or, the very least, the standard therapy offered patients.

March 30, 2017 — Aura Biosciences Announces Initiation of Phase 1b Clinical Trial and Receipt of FDA Fast Track Designation for AU - 011 for the Treatment of Primary Ocular Melanoma

MMRF and Memorial Sloan Kettering to launch a new clinical trial to identify potential genomic markers linked to achieving and maintaining deep response to therapy Read More

MSDC - 0602K is currently being evaluated in a Phase 2b clinical trial.

However, in very rare circumstances, Ionis Pharmaceuticals is able to make an experimental drug that we are developing available for patients outside of a traditional clinical trial under an expanded access protocol, sometimes referred to as a treatment protocol.

And today «s clinical trial results are expected to boost prescribing among physicians.

BioNTech hit the headlines in July when its experimental personalized cancer vaccine, tailored to the tumors of individual patients, kept disease in check in an early - stage clinical trial.

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.

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.

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.

Grail, a year - old, Menlo Park, Ca. - based early cancer screening startup that spun out of the DNA - sequencing giant Illumina is reportedly looking to raise up to $ 1.7 billion in fresh funding to launch a large - scale clinical trial.

Gainers Immuron Limited (NASDAQ: IMRN) shares jumped 71.2 percent to $ 14.46 after the company disclosed positive results in NASH clinical trial.

The company's leading program, a differentiated PPAR gamma agonist (MIN - 102) that has multiple CNS indications, has successfully completed a phase 1 clinical trial and is ready to move into a phase 2/3 study with adult AMN patients.

Take the recently published results of a clinical trial that found participants who took vitamin E, believed to be neutral or beneficial in fighting cancer, had a 17 % higher risk of prostate cancer.

Announced a clinical trial collaboration with Pfizer, Inc. (Pfizer) to evaluate the safety and efficacy of the investigational combination of Yescarta and Pfizer's utomilumab, a fully humanized 4 - 1BB agonist monoclonal antibody, in patients with refractory large B - cell lymphoma.

In May, Kite disclosed that one person had died in a clinical trial for its late - stage CAR - T therapy from cerebral edema, a condition in which excessive fluid causes the brain to swell.

Granted, it makes sense that firms want to promote their technology platforms, drug candidates, and clinical trial results.

Shares of biotech Sage Therapeutics slumped 15 % in Tuesday afternoon trading after the company's experimental seizure disorder treatment, brexanolone, failed to meet the key goal in a clinical trial.

TrialScope, a Jersey City, N.J. - based provider of clinical trial transparency and compliance solutions, has raised $ 10 million in new VC funding.

During his speech, Biden repeatedly stressed the importance of breaking down the regulatory and structural barriers to pooling clinical trial and genomic cancer sequencing data.

The idea for the database is to create a single repository for both patients» clinical trial data and the genetic specifics of their cancers, including which therapies they've been given and how effective they were.

The clinical trial of Vascepa for approval in China is in process.

Investors, however, are focused on quarterly results and often have little patience with clinical trial setbacks and the years - long process of developing drugs.

The Food and Drug Administration has given Bayer's experimental blood cancer treatment copanlisib a priority review designation after the drug showed promise in fighting back follicular lymphoma in 60 % of participants in a mid-stage clinical trial.

NOVARTIS PARTNERS WITH SCIENCE 37 TO DEVELOP «VIRTUAL TRIALS»: Swiss drugmaker Novartis announced plans to work with virtual clinical trial company Science 37 to develop «remote trial» technology that uses video conferencing to lower the barrier of entry for recruiting study participants, according to Reuters.

The case was yet more evidence that both the clinical trial doctors and the drug's developers would have to be more patient in assessing this new type of therapy.