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  • Nasdaq
  • WALTHAM, Mass., Nov. 17, 2015 (GLOBE NEWSWIRE) -- Radius Health (Nasdaq:RDUS), today announced that it has submitted a Marketing Authorization Application (MAA) for an investigational, once-daily subcutaneous injection of abaloparatide, a novel synthetic peptide. (cnbc.com)
  • facilitate
  • A key aspect of this FOA is the formation of collaborative partnerships between the biomedical researchers and biotechnology or industry researchers to facilitate psychiatric drug or device development. (nih.gov)
  • placebo
  • Participants will receive study drug or placebo once daily for up to 8 weeks, and will have a telephone visit at week 1 with additional clinic follow-up visits at 4, 8, and 10 weeks. (scripps.org)
  • chemotherapy agent
  • Several unique features make vosaroxin a particularly attractive chemotherapy agent including its resistance to P-glycoprotein-mediated drug efflux and its lack of chemical reactivity, which by not promoting the formation of reactive oxygen species, should minimize adverse effects, most notably cardiotoxicity. (globenewswire.com)
  • Food and Drug Admin
  • Source: U.S. Food and Drug Administration. (hematology.org)
  • Vonapanitase has received fast track and orphan drug designations from the U.S. Food and Drug Administration (FDA), and orphan medicinal product designation from the European Commission, for hemodialysis vascular access indications. (bioportfolio.com)
  • novel-acti
  • It is a novel-acting drug that inhibits key pro-survival signaling pathways operating via sphingosine-1-phosphate and Akt. (drugs.com)
  • Healthcare
  • This includes developing procedures to ensure timely and safe drug dispensing, maintaining inventory of investigational drugs, blinding and randomizing drug studies, serving as an information resource regarding investigational drugs and study protocols, meeting with principle investigators and study groups, participating in protocols as co-investigators and reviewing protocols as members of the Partners Healthcare Human Research Committee. (brighamandwomens.org)
  • data
  • Data in the scientific literature on PPARs, as well as animal data and early clinical data generated by GSK with these drugs, suggest that activation of PPARs may cause the body to increase its use of fatty acids for energy, and lead to a reduction in body fat. (clinicaltrials.gov)
  • orphan
  • IDS acts as an informational resource for other Brigham and Women Hospital pharmacists and clinicians to assist in answering questions and solving dispensing issues with foreign drugs, orphan drugs, continued use of non-FDA approved agents from other institutions and emergency use investigational medications. (brighamandwomens.org)
  • application
  • The Company is now turning its focus to the completion of the work streams necessary for the submission of the New Drug Application (NDA) to the FDA for the investigational drug abaloparatide-SC. (cnbc.com)
  • safety
  • While FDA is allowed to make exemptions under current law, it may choose not to do so if there are safety concerns about the drug, Robert Temple, then-associate director of the Center for Drug Evaluation and Research (CDER), testified in a 2001 hearing before the House Committee on Government Reform. (raps.org)
  • Companies may be loath to release stock of the drug, either for fear of it being used in an uncontrolled way, competitors getting access to it, unknown safety signals coming to light or insufficient manufacturing capacity. (raps.org)
  • body
  • It allows for a more controlled drug release in the body, ensuring that chemicals reach maximum absorption. (pharmacytimes.com)
  • human
  • This protocol will test a humanized monoclonal antibody known as Campath-1H for its ability to induce a state of permanent allograft acceptance, or tolerance, when administered in combination with a brief course of the immunosuppressive drug deoxyspergualin (DSG) at the time of human renal allotransplantation. (clinicaltrials.gov)
  • gene
  • Since the discovery that a loss of CFTR function causes CF ( 1 , 2 ), there have been efforts to restore CFTR function with gene therapy or drugs to ameliorate the disease ( 8 ). (pnas.org)
  • product
  • RVNC ), a specialty biopharmaceutical company developing botulinum toxin products for use in aesthetic and therapeutic indications, today announced its plans to move forward with two key clinical studies for its investigational drug product candidate RT001, a topical gel formulation of botulinum toxin type A. (globenewswire.com)
  • levels
  • The drug, given in this trial at one of four doses based on disease severity, returned blood potassium levels to normal when measured at four weeks and kept them under control for one year, the length of the trial. (eurekalert.org)
  • In mice, levels of PF-06463922 in the brain were 20% to 30% of the levels of the investigational drug in the brain. (oncologynurseadvisor.com)
  • emergency
  • With CDC assistance, however, miltefosine has been administered in combination with other drugs since 2009 for FLA infections as single-patient emergency use with permission from the FDA. (infectioncontroltoday.com)