Sentences with phrase «in late stage clinical»

Structured Abstract Introduction: The analysis of pharmaceutical industry data indicates that the major reason for drug candidates failing in late stage clinical development is lack of efficacy, with a high proportion of these due to erroneous hypotheses about target to disease linkage.

20 - 30 % of patients with acute myeloid leukemia have mutations of the FLT3 biomarker that make them eligible for several FLT3 - targeted small molecule therapies currently in late stage clinical trials.

Drug candidates currently in late stage clinical trials comprise of growth factors, which are traditional protein - based biological drugs associated with high costs, and some trials have been prematurely terminated.

Not exact matches

The combo proved non-inferior to competing HIV medicines in a slew of late - stage clinical trials, and Gilead is expected to file a new drug application with the FDA soon.

Merck is the latest company to weather bad news in the Alzheimer's drug race, halting a late - stage trial yesterday in an experimental amyloid - targeting candidate called verubecestat after a data monitoring committee said there was «virtually no chance of finding a positive clinical effect,» Reuters reported.

Intarcia has completed several late - stage clinical trials in which it uses the pump to deliver a glucose - controlling drug continuously for months — an idea, that if successful (and approved by the FDA) could significantly help patients with type 2 diabetes, fewer than half of whom maintain the recommended glycemic levels.

But a late - stage clinical trial called CheckMate - 026 for the drug failed to meet its primary goal of halting cancer progression in advanced, untreated patients whose tumors consisted of at least 5 % PD - L1.

According to PhRMA, there are more than a dozen experimental treatments that are still in phase 3, the latest stage of clinical trials before companies present their data to the FDA.

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.

The new Alzheimer's framework may not be much of a surprise given numerous, high - profile, late - stage clinical trial failures in the field by companies like Eli Lilly and Merck, and the decision by other companies (such as Pfizer) to back away from the risk - prone field.

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.

Novartis has several more biosimilars marketed in other countries (as well as an FDA approved copycat of Amgen's bestselling treatment Enbrel, which hasn't reached the U.S. yet due to patent spats), and three others in late - stage clinical development.

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 swelIn 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 swelin a clinical trial for its late - stage CAR - T therapy from cerebral edema, a condition in which excessive fluid causes the brain to swelin which excessive fluid causes the brain to swell.

Another migraine drug, lasmiditan, which Lilly picked up with its 2017 acquisition of Colucid Pharmaceuticals, is in late - stage clinical studies.

But topping the list is Vertex (VRTX), which has a veritable plethora of HCV drugs in late - stage clinical trials, which are used either alone, or in combination with other drugs.

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.

The researchers gave cefoperazone, a commonly - used antibiotic, to mouse mothers in the late stages of pregnancy through the period that they nursed their pups, i.e. to mimic a common clinical scenario of early antibiotic exposure in humans.

If our late - stage clinical development fails, we are in trouble.

«Unfortunately, most clinical trials to date have focused on patients whose cognitive deficits are already mild to severe, and when the therapeutic opportunities in this late stage of the disease are minimal.

AAV is in use in many late - stage clinical trials in the United States, and has already been approved for use in one gene therapy drug in the European Union.

One company, Melbourne, Australia — based Mesoblast, is already in late - stage clinical trials, treating hundreds of chronic heart failure patients with stem cell precursors drawn from healthy donors» hip bones.

Two recent, late - stage clinical trials were stopped because nusinersen, developed by Ionis of Carlsbad, California, and now licensed to Biogen of Cambridge, Massachusetts, was so effective in restoring motor function in children and babies that it was deemed unethical to deny the drug to children in the placebo arms of the trials.

Vtesse is currently running a late - stage clinical trial of the drug, a large sugar molecule known as a cyclodextrin, in which it is injected by lumbar puncture into the spinal fluid of children with the disease (see «Why are people fighting over a promising treatment for a fatal childhood disease»).

A drug used to treat men with late - stage prostate cancer proved effective in stemming progression of the disease in research participants who had not yet received chemotherapy and extended their survival, according to results from a multi-national Phase III clinical trial led by the Knight Cancer Institute at Oregon Health & Science University (OHSU).

Results released earlier this year from a clinical trial in mid - to late - stage Alzheimer's patients were «a bit of a mixed bag,» says Hale.

Conventional drug discovery remains a hit - and - miss affair and Hunter believes the 50 percent failure rates seen for experimental compounds in mid - and late - stage clinical trials due to lack of efficacy is unsustainable, forcing a shift to AI.

BWF Clinical Scientist Awards in Translational Research provide $ 750,000 over 5 years to faculty members in the late - assistant - professor or early - associate - professor stages of their careers.

The study, a retrospective survival analysis, included 229 patients who participated in two randomized, controlled clinical trials focused on relief of constipation for patients receiving palliative care for various types of late - stage cancer and other terminal diseases.

The board has approved $ 50 million in spending to support the first 6 months under the new funding mechanism, which will be available to «late preclinical» and clinical stage projects.

The test is currently in the later stages of clinical trials with plans to go to market in the next 18 months.

But while many appear to be effective in animal models, most fail when tested in late - stage human clinical trials.

Several types of immunotherapy for glioblastoma are in late - stage clinical trials.

Activists often slam large pharmaceutical companies for failing to develop drugs that are of critical importance to the developing world.Andrew Witty, GlaxoSmithKline's youthful chief executive, gave those critics pause yesterday in a speech to the Council on Foreign Relations in New York City.Witty promised to sell the company's malaria vaccine that is in late - stage clinical trials in Africa for no more than a 5 percent profit.

All six patients suffered from end - stage heart disease and were enrolled in this first - in - human (FIH) clinical trial, approved by the U.S. Food and Drug Administration in late 2015.

Although some anti-amyloid drugs are currently in late - stage clinical testing, several trials have also failed and there is much debate as whether this is a suitable approach for a new treatment.

Table 1: Selection, Design & Construction of HSV - based Oncolytic Viruses Table 2: Selection, Design & Construction of Adenovirus - based Oncolytic Viruses Table 3: Selection, Design & Construction of Vaccinia Virus - based Oncolytic Viruses Table 4: Selection, Design & Construction of Vesicular Stomatitis Virus - based Oncolytic Viruses Table 5: Selection, Design & Construction of Newcastle Disease Virus - based Oncolytic Viruses Table 6: Selection, Design & Construction of Various Virus - based Oncolytic Viruses Table 7: Current Company - Sponsored Clinical Trials of T - Vec Table 8: Clinical Trials of ColoAd1 Table 9: Clinical Trials with JX - 594 Table 10: Clinical Trials with GL - ONC1 Table 11: Clinical Trials of CAVATAK (CVA21) Table 12: Clinical Trials with MV - NIS Table 13: Overview of Oncolytic Viruses by Development Phase & Virus Family Table 14: Profile of Approved and Marketed Oncolytic Viruses Table 15: Pivotal Study Design of Oncolytic Viruses in Late Stage Development Based on Previous Clinical Results Table 16: Approved Indications of Immune Checkpoint Inhibitors Table 17: Active Clinical Studies of Oncolytic Viruses in Combination with Immune Checkpoint Inhibitors (ICI) Table 18: Planned Clinical Studies of Oncolytic Viruses in Combination with Immune Checkpoint Inhibitors (ICI) Table 19: Active or Planned Clinical Studies of Oncolytic Viruses in Combination with Other Anti-Cancer Therapeutics Table 20: Pattern of Transgenes in Oncolytic Viruses in Relation to Development Phase Tables 21a and 21b: Indications and Frquency and Way of Administration of Oncolytic Viruses in Active and / or Positive Completed Clinical Studies Table 22: Small and Medium Pharma & Biotech as Partner for Regional Co-Development of Oncolytic Viruses Table 23: Immuno - Oncology Portfolio of Major Pharma & Biotech with Interest in Oncolytic Viruses Table 24: Interests of Major Pharma & Biotech in Oncolytic Viruses Table 25: First Generation Oncology Virus Companies and their Sources of Technology Table 26: Second Generation Oncology Virus Companies and their Sources of Technology Table 27: Third Generation Oncology Virus Companies and their Sources of Technology Table 28: Fourth Generation Oncology Virus Companies and their Sources of Technology Table 29: Grants, Credits & Donations Table 30: Financing by Venture Capital, Private Equity and Other Private Placements Table 31: Collaboration & Licensing Agreements Table 32: Companies Listed on Stock Exchange & Offerings Table 33: Mergers & Acquisitions

The NCTN — which will focus on early and late stage clinical trials for adults with cancer — will consist of fewer but larger groups of investigators and will distribute resources in a more effective way.

Production of CCS1477 in capsule form is now complete, ahead of forthcoming first - in - human clinical trials to investigate the novel drug's tolerability and efficacy in treating late stage prostate cancer (CRPC).

These mutant kinases are attractive therapeutic targets, as demonstrated by the efficacy of imatinib in BCR - ABL — positive chronic myelogenous leukemia (CML), 5 as well as in MPD associated with activating alleles involving PDGFRA or PDGFRB.2, 6,7 In addition, activating mutations in the FLT3 receptor tyrosine kinase are the most common genetic event in acute myeloid leukemia (AML), and specific inhibitors of the FMS - like tyrosine kinase 3 (FLT3) have entered late - stage clinical trials.8 Although mutations in tyrosine kinases and in other genes have been identified in a subset of MPD and AML, in many cases the genetic events that contribute to the molecular pathogenesis of these diseases remain unknowin BCR - ABL — positive chronic myelogenous leukemia (CML), 5 as well as in MPD associated with activating alleles involving PDGFRA or PDGFRB.2, 6,7 In addition, activating mutations in the FLT3 receptor tyrosine kinase are the most common genetic event in acute myeloid leukemia (AML), and specific inhibitors of the FMS - like tyrosine kinase 3 (FLT3) have entered late - stage clinical trials.8 Although mutations in tyrosine kinases and in other genes have been identified in a subset of MPD and AML, in many cases the genetic events that contribute to the molecular pathogenesis of these diseases remain unknowin MPD associated with activating alleles involving PDGFRA or PDGFRB.2, 6,7 In addition, activating mutations in the FLT3 receptor tyrosine kinase are the most common genetic event in acute myeloid leukemia (AML), and specific inhibitors of the FMS - like tyrosine kinase 3 (FLT3) have entered late - stage clinical trials.8 Although mutations in tyrosine kinases and in other genes have been identified in a subset of MPD and AML, in many cases the genetic events that contribute to the molecular pathogenesis of these diseases remain unknowIn addition, activating mutations in the FLT3 receptor tyrosine kinase are the most common genetic event in acute myeloid leukemia (AML), and specific inhibitors of the FMS - like tyrosine kinase 3 (FLT3) have entered late - stage clinical trials.8 Although mutations in tyrosine kinases and in other genes have been identified in a subset of MPD and AML, in many cases the genetic events that contribute to the molecular pathogenesis of these diseases remain unknowin the FLT3 receptor tyrosine kinase are the most common genetic event in acute myeloid leukemia (AML), and specific inhibitors of the FMS - like tyrosine kinase 3 (FLT3) have entered late - stage clinical trials.8 Although mutations in tyrosine kinases and in other genes have been identified in a subset of MPD and AML, in many cases the genetic events that contribute to the molecular pathogenesis of these diseases remain unknowin acute myeloid leukemia (AML), and specific inhibitors of the FMS - like tyrosine kinase 3 (FLT3) have entered late - stage clinical trials.8 Although mutations in tyrosine kinases and in other genes have been identified in a subset of MPD and AML, in many cases the genetic events that contribute to the molecular pathogenesis of these diseases remain unknowin tyrosine kinases and in other genes have been identified in a subset of MPD and AML, in many cases the genetic events that contribute to the molecular pathogenesis of these diseases remain unknowin other genes have been identified in a subset of MPD and AML, in many cases the genetic events that contribute to the molecular pathogenesis of these diseases remain unknowin a subset of MPD and AML, in many cases the genetic events that contribute to the molecular pathogenesis of these diseases remain unknowin many cases the genetic events that contribute to the molecular pathogenesis of these diseases remain unknown.

In one eye - opening review of recent research, Charles Drake, M.D., Ph.D., of Johns Hopkins, who is also a member of CRI's clinical trials network, discussed several cancer vaccines that are making progress, including coxsackievirus A21, an oncolytic virus vaccine being studied in late stage melanoma, and NewLink's algenpantucel - L in pancreatic cancer (HyperAcute ® pancreasIn one eye - opening review of recent research, Charles Drake, M.D., Ph.D., of Johns Hopkins, who is also a member of CRI's clinical trials network, discussed several cancer vaccines that are making progress, including coxsackievirus A21, an oncolytic virus vaccine being studied in late stage melanoma, and NewLink's algenpantucel - L in pancreatic cancer (HyperAcute ® pancreasin late stage melanoma, and NewLink's algenpantucel - L in pancreatic cancer (HyperAcute ® pancreasin pancreatic cancer (HyperAcute ® pancreas).

Much of the research effort to find new drugs to treat this disease has focused on the senile plaques, but so far these drugs have all failed in late - stage clinical trials.

I've been working for the last 5 years in trying to bring image resolution to «in vivo» imaging comparable to microscopy because right now we believe there is a disconnect between the clinical imaging that looks at very microscopic features of the eye that are informative of the disease but usually at very late stages and the exquisite work that molecular biologists are doing.

The Clinical Utility of Oncotype DX and MammaPrint The AJCC Cancer Staging Manual, eighth edition published in late 2016, will become the new global guideline for cancer diagnosis and treatment from January 1, 2018.

Despite ongoing efforts toward finding novel entities for the treatment of the most challenging cancers, translation into patient benefit has been slow due to the fact that translational cancer research from early drug discovery to late stage drug development and assessment in clinical trials is a long process.

Dogs showing clinical signs for > 7 days should be tested for CIV by an antibody test as the virus itself is often undetectable in later stages of illness, as is true for most respiratory viral infections.

But there is a glitch in one of the late stage clinical trials.

Tags for this Online Resume: Biotechnology, Diagnostic, Pharmaceutical, Marketing, Oncology, Strategy, Brand Planning, Global Marketing, New Product Planning, Pricing, Market Research, Brand Leader, Commercial, Commercialization, Launch, Drug Development, Matrix, Cross Functional, Digital, KOL, Key Opinion Leader, Portfolio, Management, Brand Team, Agency, Diabetes, Cardiovascular, Commercial Strategy, Corporate Affairs, Communications, Hematology, Urology, Neuroscience, phase 2, phase 3, phase II, phase III, Powerpoint, Excel, Word, Part B, Part D, Seattle, Portland, San Francisco, Executive Director, Senior Director, Director, Vice President, Go - To - Market, Value Proposition, Go To Market, Launch Planning, Access, Reimbursement, Payer, Market Development, Market Assessment, Pipeline, In - Line, Brand Management, Coaching, Leadership, Marketing Strategies, Marketing Strategy, Strategic Planning, Autoimmune, Early Stage, Pre-Launch, Pre Launch, Regulatory, Operations, Marketing Plan, Business Plan, Business Development, Market Analysis, Segmentation, Targeting, Companion Diagnostic, Target Product Profile, Pre-Clinical, Competition, Positoning, Branding, Sales, Budget, Sales Management, Communication Plan, Publication Plan, Project Management, Genetic, Genomic, Lifecycle, Long Range, Device, Late Stage, Direct Report, Indirect Report, New Molecular Entities, Competitive, Biopharmaceutical, Medical Device, Non-Promotional, Tactical, Execution, IND, Revenue, Partner, Clinical, Consult, Analytical, Problem Solver, Global, International, Affordable Care Act, Lymphoma, Leukemia, Prostate, Breast, Cancer, OPDP, Promotional, Promotions, Brand, Healthcare, Distribution, Infrastructure, IMS, Priority Review, Experienced, Patient, Consumer