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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]
FDA removes partial clinical hold on CytRx's aldoxorubicin clinical trials

FDA removes partial clinical hold on CytRx's aldoxorubicin clinical trials

CytRx Corporation, a biopharmaceutical research and development company specializing in oncology, today announced that the United States Food and Drug Administration has removed the partial clinical hold on the Company's aldoxorubicin clinical trials. [More]
AMRI awarded NIH contract for drug development services

AMRI awarded NIH contract for drug development services

AMRI today announced it received a 10-year federal contract award from the National Institutes of Health for drug development and manufacturing services. This NIH/National Institute of Neurological Disorders and Stroke award will support NIH's Drug Manufacturing and Formulation Program (DMFP), which is a component of the Blueprint Neurotherapeutics Network (BPN). [More]
Aptose begins APTO-253 clinical study in patients with relapsed or refractory hematologic malignancies

Aptose begins APTO-253 clinical study in patients with relapsed or refractory hematologic malignancies

Aptose Biosciences Inc., a clinical-stage company developing new therapeutics and molecular diagnostics that target the underlying mechanisms of cancer, today announced dosing of the first patient in its Phase 1b clinical study of APTO-253 in patients with relapsed or refractory hematologic malignancies. [More]
CytRx reports positive interim results from aldoxorubicin Phase 2 trial for HIV-related Kaposi's Sarcoma

CytRx reports positive interim results from aldoxorubicin Phase 2 trial for HIV-related Kaposi's Sarcoma

CytRx Corporation, a biopharmaceutical research and development company specializing in oncology, today announced positive interim results from its ongoing Phase 2 clinical trial evaluating the safety and efficacy of aldoxorubicin for the treatment of Kaposi's Sarcoma (KS) in HIV-infected patients. [More]
CytRx reports positive interim results from aldoxorubicin Phase 2 trial for treatment of GBM

CytRx reports positive interim results from aldoxorubicin Phase 2 trial for treatment of GBM

CytRx Corporation, a biopharmaceutical research and development company specializing in oncology, today announced positive interim results from its ongoing Phase 2 clinical trial with aldoxorubicin for the treatment of unresectable glioblastoma multiforme (GBM), a deadly form of brain cancer. [More]