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Transition announces positive results from ELND005 AME and renal clearance studies

Transition announces positive results from ELND005 AME and renal clearance studies

Transition Therapeutics Inc. today announced results from two phase 1 clinical studies of neuropsychiatric drug candidate ELND005. These studies, an absorption-metabolism-excretion ("AME") study and a renal clearance study, are specialized clinical pharmacology trials that are required by the United States Food and Drug Administration for the approval of most drugs in development. [More]
Isis Pharmaceuticals announces positive results from ISIS-ANGPTL3Rx Phase 1 study

Isis Pharmaceuticals announces positive results from ISIS-ANGPTL3Rx Phase 1 study

Isis Pharmaceuticals, Inc. announced today positive results from a Phase 1 study with ISIS-ANGPTL3Rx. In this study, healthy volunteers treated with ISIS-ANGPTL3Rx achieved dose-dependent, statistically significant reductions in angiopoietin-like 3 (ANGPTL3) of up to 93 percent with a mean reduction of up to 84 percent from baseline (p<0.001). [More]
UF pharmacy dean to be honored with 2015 SURA Distinguished Scientist Award

UF pharmacy dean to be honored with 2015 SURA Distinguished Scientist Award

SURA today announced that Julie A. Johnson, Dean and Distinguished Professor at the University of Florida's College of Pharmacy, will receive its 2015 SURA Distinguished Scientist Award. [More]
Blunted cortisol response common in non-classic CAH

Blunted cortisol response common in non-classic CAH

Nearly two-thirds of children with non-classic congenital adrenal hyperplasia have an inadequate cortisol response, report researchers. [More]

Vrije University Brussels installs MILabs PET-SPECT-CT-MRI platform for nanobody research

The comprehensive MILabs PET-SPECT-CT-MR preclinical platform combines the best PET-SPECT functional imaging capabilities (sub-half-mm SPECT resolution and sub-mm PET resolution) with high resolution anatomical imaging from an integrated X-ray CT subsystem and/or a compact cryogen free 1.5 T MRI unit [More]
Bayer announces FDA acceptance of BAY 81-8973 BLA for treatment of hemophilia A

Bayer announces FDA acceptance of BAY 81-8973 BLA for treatment of hemophilia A

Bayer HealthCare today announced that the U.S. Food and Drug Administration has accepted the company's Biologics License Application for BAY 81-8973, a recombinant Factor VIII compound. Bayer is seeking FDA approval of the investigational compound, proposed trade name Kovaltry, for the treatment of hemophilia A in children and adults. [More]
Symbiomix Therapeutics announces positive results from SYM-1219 Phase 1 clinical program

Symbiomix Therapeutics announces positive results from SYM-1219 Phase 1 clinical program

Symbiomix Therapeutics, a late-stage, privately held biopharmaceutical company developing innovative medicines for serious women's health infections, today announced results from its Phase 1 clinical program demonstrating that its lead product candidate, SYM-1219, was safe and well tolerated and had predictable pharmacokinetics (PK), and that contraceptive efficacy for birth control pills would not be altered by SYM-1219 administration. [More]
Mundipharma launches Remsima® (infliximab), a new-generation value-based monoclonal antibody, in six European markets

Mundipharma launches Remsima® (infliximab), a new-generation value-based monoclonal antibody, in six European markets

Mundipharma International Limited’s network of independent associated companies are launching Remsima® (infliximab) this month in Germany, Italy, UK, Netherlands, Belgium and Luxembourg following expiry of the relevant patents and Supplementary Protection Certificates, having secured distribution rights from Celltrion Healthcare Hungary Kft for Remsima in these markets. [More]
Isis Pharmaceuticals announces positive results from Phase 1 study of ISIS-PKK Rx for HAE treatment

Isis Pharmaceuticals announces positive results from Phase 1 study of ISIS-PKK Rx for HAE treatment

Isis Pharmaceuticals, Inc. announced today positive results from a Phase 1 study with ISIS-PKKRx. In this study, healthy volunteers treated with ISIS-PKKRx achieved dose-dependent reductions of up to 95 percent in prekallikrein, or PKK. ISIS-PKKRx is a RNA-targeted antisense drug designed to inhibit the production of PKK for the prophylactic treatment of hereditary angioedema (HAE). [More]

Added benefit of simoctocog alfa not proven for haemophilia A

Simoctocog alfa (trade name Nuwiq) has been approved since July 2014 for people with type A haemophilia, an inherited disorder that impairs blood clotting. The German Institute for Quality and Efficiency in Health Care examined in a dossier assessment whether this new drug offers an added benefit over the appropriate comparator therapy. Such an added benefit cannot be derived from the dossier, however, because the drug manufacturer did not submit any suitable data. [More]
Clinical data demonstrates safety, efficacy of vedolizumab for treatment of adults with UC and CD

Clinical data demonstrates safety, efficacy of vedolizumab for treatment of adults with UC and CD

Takeda Pharmaceuticals International GmbH today announced the presentation of data further demonstrating the efficacy and safety of vedolizumab for the treatment of adults with moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD). [More]
NIH-sponsored clinical trials examine safety, acceptability of HIV antiretroviral medicines

NIH-sponsored clinical trials examine safety, acceptability of HIV antiretroviral medicines

Two new clinical trials are examining the safety and acceptability of antiretroviral medicines administered via injection as a means of protecting against HIV infection. The studies are being funded by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, and conducted by the NIAID-funded HIV Prevention Trials Network (HPTN). [More]
TB Alliance announces initiation of first human trial of new TB drug candidate

TB Alliance announces initiation of first human trial of new TB drug candidate

TB Alliance has announced the start of the first human trial of a new tuberculosis (TB) drug candidate, designated TBA-354. It is the first new TB drug candidate to begin a Phase 1 clinical trial since 2009. [More]
Elusys presents positive results of obiltoxaximab for treating inhalational anthrax, post-exposure prophylaxis

Elusys presents positive results of obiltoxaximab for treating inhalational anthrax, post-exposure prophylaxis

Elusys Therapeutics, Inc. (Elusys), a biopharmaceutical company developing antibody therapies to treat infectious disease, presented data demonstrating that obiltoxaximab (ETI-204) demonstrated a statistically significant survival benefit across a range of disease severity in animal model studies assessing treatment of inhalational anthrax, as well as effectiveness in post-exposure prophylaxis. [More]
AMRI optimizes global operations to improve continuous supply chain across its businesses

AMRI optimizes global operations to improve continuous supply chain across its businesses

AMRI today announced that it has implemented several changes to further optimize global business operations in order to enhance continuity from early development through to commercial supply and accelerate the company's global growth objectives. [More]
AMRI reports financial and operating results for Q4 and FY 2014

AMRI reports financial and operating results for Q4 and FY 2014

AMRI today reported financial and operating results for the fourth quarter and full year ended December 31, 2014. [More]
Synthetic Biologics reports positive results from SYN-004 Phase 1b trial to prevent C. difficile infection

Synthetic Biologics reports positive results from SYN-004 Phase 1b trial to prevent C. difficile infection

Synthetic Biologics, Inc., a developer of pathogen-specific therapies for serious infections and diseases, with a focus on protecting the microbiome, today announced positive topline safety and tolerability results from a Phase 1b clinical trial of SYN-004, the Company's investigational oral beta-lactamase enzyme designed to protect the microbiome and prevent Clostridium difficile (C. difficile) infection, antibiotic-associated diarrhea and secondary antibiotic-resistant infections in patients receiving intravenous (IV) beta-lactam antibiotic therapy. [More]
Regulus Therapeutics reports top-line results from RG-101 clinical study for HCV treatment

Regulus Therapeutics reports top-line results from RG-101 clinical study for HCV treatment

Regulus Therapeutics Inc., a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today announced top-line results from the 4 mg/kg cohort and additional results from the 2 mg/kg cohort in a completed clinical study evaluating RG-101, a wholly-owned, GalNac-conjugated anti-miR targeting microRNA-122 ("miR-122"), for the treatment of hepatitis C virus infection ("HCV"). [More]
Researchers devise new technique to deliver cancer treatment

Researchers devise new technique to deliver cancer treatment

A team of researchers has devised a new way to target tumors with cancer-fighting drugs, a discovery that may lead to clinical treatments for cancer patients. [More]
Bionomics initiates BNC210 Phase 1b clinical trial in healthy volunteers

Bionomics initiates BNC210 Phase 1b clinical trial in healthy volunteers

Bionomics Limited has initiated a Phase 1b clinical trial in healthy volunteers of BNC210, the Company's drug candidate in development for the treatment of anxiety and depression. [More]
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