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  • viral burden
  • To study in detail the immune effects of lowering viral burden with antiviral combination drugs with and without T cell infusion on antiviral CTL activity, viral suppression and proliferation, circulating T cell phenotype, T cell apoptosis, CD4 cell numbers, DTH reaction, and inflammatory cytokine levels. (clinicaltrials.gov)
  • Protease
  • Researchers at the National Institutes of Health have discoveredthat a combination of protease inhibitors and other anti-HIV drugsused to treat people with AIDS can prevent or delay the progression ofcytomegalovirus (CMV) retinitis, a potentially blinding eyecomplication of AIDS. (nih.gov)
  • Protease inhibitors are aclass of promising drugs recently introduced that, when taken withother HIV-fighting medications, have shown success in prolonging thelives of people with AIDS. (nih.gov)
  • 2000
  • Since its inception in 2000, TopoTarget has developed a strong, two-pronged strategy for expanding its drug portfolio. (wikipedia.org)
  • The Cognitive Behavioral Analysis System of Psychotherapy (CBASP) is a talking therapy, a synthesis model of interpersonal and cognitive and behavioral therapies developed (and patented) by James P. McCullough Jr [2000, of Virginia Commonwealth University specifically for the treatment of all varieties of DSM-IV Chronic Depression. (wikipedia.org)
  • Since its inception in 2000, TB Alliance has worked to grow the field of available treatments for TB and now manages the largest pipeline of new TB drugs in history. (wikipedia.org)
  • progression
  • Has advanced HIV disease or disease progression while receiving 8 weeks or more of continuous unchanged anti-HIV therapy. (clinicaltrials.gov)
  • Out-licensing of its products to larger pharmaceutical companies, however, facilitates the progression of drugs with broad market potential through the final stages of clinical development, regulatory approval, and marketing by taking advantage of their established reputations and knacks for navigating the later stages of commercialization. (wikipedia.org)
  • orphan
  • Metastatic breast cancer impacts about 150,000 people in the USA, due to the patient population, Eisai was able to file and New Drug Application (NDA) under the orphan and rare disease designation. (wikipedia.org)
  • findings
  • Our findings suggest that the combination of proteaseinhibitors and other anti-HIV medications can restore the immunesystem to a point where it can fight the CMV retinitis infection onits own," said Dr. Scott Whitcup, clinical director of NEI andfirst author of the JAMA letter. (nih.gov)
  • often
  • Treatment of infection often involves a combination of antifungal drug therapy and surgical excision. (wikipedia.org)
  • CBASP is often mistakenly labeled a variant of Cognitive Therapy (CT) or Cognitive Behavioral Therapy (CBT) but it is not. (wikipedia.org)
  • Drug resistance occurs for several reasons, often as a natural consequence of gene mutations and selection, as a consequence of drug-efflux mechanisms, or due to drug modifying enzymes. (wikipedia.org)
  • This is often true of a drug of last resort. (wikipedia.org)
  • It was never meant to imply that these drugs are actually "breakthroughs," and it does not ensure that they will provide clinical benefit, but still critics complain that they are based on preliminary evidence, including changes in surrogate markers such as laboratory measurements, that often don't reflect "meaningful clinical benefit. (wikipedia.org)
  • designation
  • Breakthrough therapy is a United States Food and Drug Administration designation that expedites drug development that was created by Congress under Section 902 of the 9 July 2012 Food and Drug Administration Safety and Innovation Act. (wikipedia.org)
  • The FDA has other mechanisms for expediting the review and approval process for promising drugs, including fast track designation, accelerated approval, and priority review. (wikipedia.org)
  • Critics have said that the name is misleading and provides companies that obtain a breakthrough designation for a drug candidate with a marketing advantage that may be undeserved. (wikipedia.org)
  • The FDA guidance states: "Not all products designated as breakthrough therapies ultimately will be shown to have the substantial improvement over available therapies suggested by the preliminary clinical evidence at the time of designation. (wikipedia.org)
  • The fourth expedited approval mechanism-the Breakthrough Therapy designation-applies to a new drug product if it "is intended, alone or in combination with 1 or more other drugs, to treat a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on 1 or more clinically significant endpoints. (wikipedia.org)
  • adverse events
  • Our study showed no significant increase in serious adverse events in the combination therapy," said Stephen Peters, M.D., Ph.D., professor of pulmonary, critical care, allergy and immunologic diseases at Wake Forest Baptist Medical Center and lead author of the study. (wakehealth.edu)
  • resistance
  • However, even the most potent drug regimens do not seem to be curative, may eventually lead to drug resistance and may not completely restore lost immune function. (clinicaltrials.gov)
  • This can inhibit control of the disease and fuel the rise of drug resistance. (wikipedia.org)
  • This poses a limitation for their use in combination therapy, for overcoming drug resistance. (wikipedia.org)
  • This creates conditions within the patient that enable drug resistance to arise or even to become prevalent. (wikipedia.org)
  • As more and more drug-resistance conferring mutations develop in the HIV's genome, it becomes difficult to select an ARV that will meaningfully suppress HIV replication and keep the patient's viral load low. (wikipedia.org)
  • inhibit
  • Mazur and Herner wondered whether tinkering with a cell's epigenetics could control the growth and proliferation of pancreatic cancer cells without causing many of the deleterious side effects seen by drugs that inhibit protein members of the Ras pathway, a cellular signaling cascade that controls cell growth, development and survival. (healthcanal.com)
  • pharmaceutical
  • He is a consultant to the National Institutes of Health and to pharmaceutical/biotech companies in all phases of drug development in preparation for presentation to the FDA and their advisory panels. (wikipedia.org)
  • The TB drug market lacks sufficient financial incentives to stimulate a single private pharmaceutical company to invest in the new research required to sustain a treatment pipeline. (wikipedia.org)
  • A variety of derivatives of biguanide are used as pharmaceutical drugs. (wikipedia.org)
  • novel
  • Participants stressed the need for faster-acting, novel TB drugs and highlighted the scientific opportunities involved. (wikipedia.org)
  • diseases
  • The diagnosis and treatment of chromoblastomycosis by F. pedrosoi remains clinically challenging due to the relative rarity of the disease, its slow, chronic nature, the absence of clinical features readily differentiating it from other more common diseases such as squamous cell carcinoma, the restricted nature of therapies, and the lack of literature. (wikipedia.org)
  • The most common diseases that require salvage therapy are HIV and various cancers. (wikipedia.org)
  • conjunction
  • The Alavida program can be used in conjunction with other therapy and programs such as SMART Recovery, or as a preparatory program for abstinence. (wikipedia.org)
  • and in Type 1 diabetes when used in conjunction with insulin therapy. (wikipedia.org)
  • shown
  • A new combination drug therapy (sulfonamide, ceftriaxone, and amikacin) has also shown promise. (wikipedia.org)
  • It has been shown that the bactericidal actions of the drug do not increase with concentrations of piperacillin higher than 4-6 x MIC, which means that the drug is concentration-independent in terms of its actions. (wikipedia.org)
  • disease
  • increasing in frequency as people with AIDS live longer, with up to40% of all adults with AIDS eventually developing the disease.Standard treatment for CMV retinitis, which can cause blindness ifleft untreated, requires life-long medication with a variety ofanti-CMV drugs that can be cumbersome, costly, and toxic. (nih.gov)
  • increase
  • Allowing each sector to focus on its specialty in the drug development timeline maximizes TopoTarget's use of time and resources to increase productivity. (wikipedia.org)
  • cancer
  • The drugs, which affect the structure and function of the cancer cell's DNA rather than the activity of its proteins, also slowed the growth of human lung cancer cells in mice. (healthcanal.com)
  • The researchers hope to soon test the drug combination in humans with pancreatic cancer. (healthcanal.com)
  • Mazur tried eight drugs in combination with JQ1, each targeting either a known cancer-associated pathway or a step involved in epigenetics. (healthcanal.com)
  • This was followed by the purchase of G2M Cancer Drugs AG in Germany in 2005. (wikipedia.org)
  • One of these drugs-Belinostat-has proved particularly promising and forms the basis of TopoTarget's research collaboration with the National Cancer Institute in the USA. (wikipedia.org)
  • Food
  • Dr. Steers was a member of the U.S. Food and Drug Administration's (FDA)Reproductive Medicine Advisory Panel, and chaired the National Institutes of Health's Urinary Incontinence and Interstitial Cystitis clinical trial groups. (wikipedia.org)
  • in 1993, IFN β-1b was approved by the U.S. Food and Drug Administration for that very purpose. (wikipedia.org)
  • United States Food and Drug Administration. (wikipedia.org)
  • development
  • The CEO is Peter Buhl Jensen, M.D., Ph.D. At the end of 2007, TopoTarget had a total of 146 employees who worked in drug development (including assay development, medicinal chemistry, preclinical research, and clinical trials), marketing, and sales. (wikipedia.org)
  • By 2006 TopoTarget had 125 employees specializing in most areas of drug discovery and development. (wikipedia.org)
  • The Global Alliance for TB Drug Development (TB Alliance) is a not-for-profit product development partnership dedicated to the discovery and development of new, faster-acting and affordable tuberculosis medicines. (wikipedia.org)
  • However, research and development for new TB drugs came to a virtual standstill after the 1960s. (wikipedia.org)
  • The resulting "Declaration of Cape Town" provided a road map for TB drug development and outlined the need for creation of the TB Alliance. (wikipedia.org)
  • While retaining management oversight of its drug development projects, the TB Alliance out-sources the development of potential drugs to public and private partners, providing funding and scientific guidance. (wikipedia.org)
  • ensure
  • The TB Alliance was designed to be the primary instrument to fill this vacuum and to ensure that new anti-TB drugs are affordable and accessible in endemic countries. (wikipedia.org)