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Baxter reports topline results from BAX 111 Phase 3 trial for treatment of von Willebrand disease

Baxter International Inc. today announced topline results from a Phase 3 clinical trial evaluating the safety, efficacy and pharmacokinetics (PK) of BAX 111. BAX 111 is a recombinant von Willebrand factor (rVWF) under investigation for the treatment of bleeding episodes in patients with von Willebrand disease, the most common type of inherited bleeding disorder. [More]
Community efforts boost people for HIV testing and reduce new infections

Community efforts boost people for HIV testing and reduce new infections

Communities in Africa and Thailand that worked together on HIV-prevention efforts saw not only a rise in HIV screening but a drop in new infections, according to a new study in the peer-reviewed journal The Lancet Global Health. [More]
Pradaxa receives FDA approval for treatment and reduction of risk of recurrence of DVT and PE

Pradaxa receives FDA approval for treatment and reduction of risk of recurrence of DVT and PE

Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Pradaxa® (dabigatran etexilate mesylate) for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant for five to 10 days, and to reduce the risk of recurrent DVT and PE in patients who have been previously treated. DVT and PE are collectively referred to as venous thromboembolism (VTE). [More]

Study shows administering steroids during cardiac surgery requiring bypass can cause harm

Giving patients steroids at the time of heart surgery does not improve health outcomes and appears to put them at greater risk of having a heart attack in the days following surgery, according to research presented at the American College of Cardiology's 63rd Annual Scientific Session. [More]
Biogen Idec's ALPROLIX receives FDA approval for hemophilia B treatment

Biogen Idec's ALPROLIX receives FDA approval for hemophilia B treatment

Today Biogen Idec announced that the U.S. Food and Drug Administration has approved ALPROLIX [Coagulation Factor IX (Recombinant), Fc Fusion Protein], the first recombinant, DNA derived hemophilia B therapy with prolonged circulation in the body. [More]
Experimental vaccine for HSV-2 infection reduces rate of viral shedding at 6 months

Experimental vaccine for HSV-2 infection reduces rate of viral shedding at 6 months

Updated Phase 1/2a results with GEN-003, a vaccine candidate under development by Genocea Biosciences, Inc. (Nasdaq: GNCA) for the treatment of herpes simplex virus type 2 (HSV-2) infection, showed the experimental vaccine to generate highly significant reductions in both the number of clinical lesion days and rate of viral shedding at six months after the final vaccine dose. [More]
Biogen Idec's ALPROLIX gets Health Canada approval for hemophilia B

Biogen Idec's ALPROLIX gets Health Canada approval for hemophilia B

Today Biogen Idec announced that Health Canada has approved ALPROLIX [Coagulation Factor IX (Recombinant), Fc Fusion Protein], for the control and prevention of bleeding episodes and routine prophylaxis in adults, and children aged 12 and older, with hemophilia B. [More]
Merck's NOXAFIL injection gets FDA approval for intravenous use

Merck's NOXAFIL injection gets FDA approval for intravenous use

Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration has approved NOXAFIL (posaconazole) injection (18 mg/ mL), a new formulation of NOXAFIL for intravenous (IV) use. [More]
Bristol-Myers Squibb, Pfizer announce FDA approval of Eliquis for DVT prophylaxis

Bristol-Myers Squibb, Pfizer announce FDA approval of Eliquis for DVT prophylaxis

Bristol-Myers Squibb Company and Pfizer Inc. today announced that the U.S. Food and Drug Administration approved a Supplemental New Drug Application (sNDA) for Eliquis (apixaban) for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery. [More]
OPKO Health consolidated revenues increase about 30% to $20.7 million in Q4 2013

OPKO Health consolidated revenues increase about 30% to $20.7 million in Q4 2013

OPKO Health, Inc., a multi-national biopharmaceutical and diagnostics company, today reported operating and financial results for its 2013 fourth quarter and full year ended December 31, 2013. [More]
UNC receives $40M for clinical trials unit devoted to HIV/AIDS treatment, prevention and research

UNC receives $40M for clinical trials unit devoted to HIV/AIDS treatment, prevention and research

The University of North Carolina at Chapel Hill has received a seven-year, more than $40 million award from the National Institutes of Health for a clinical trials unit that will implement the scientific agendas of five NIH networks devoted to HIV/AIDS treatment, prevention, and cure research. [More]

Hu-Friedy, EMS partner to deliver clinically advanced prophylaxis protocol to U.S. and Canadian markets

Hu-Friedy, a global leader in the manufacturing of dental instruments and products, and Switzerland-based Electro Medical Systems today announced a strategic alliance to deliver the most clinically advanced prophylaxis protocol to the U.S. and Canadian markets by leveraging Hu-Friedy's heritage in high-quality hand instrumentation, coupled with best-in-class EMS offerings in Piezo power scaling and air polishing. [More]

FDA accepts Regado Biosciences' IND application for REG2

Regado Biosciences, Inc., a biopharmaceutical company focused on the late-stage clinical development of its first-in-class, actively controllable antithrombotic drug system, REG1, today announced that the United States Food and Drug Administration has accepted the company's investigational new drug (IND) application for REG2. Regado previously completed a single escalating-dose Phase 1 clinical trial of REG2 and plans to conduct additional clinical testing in sub-acute venous thrombosis indications in the future. [More]
Urinary tract infections linked to acute psychosis relapse

Urinary tract infections linked to acute psychosis relapse

Patients with an acute episode of psychosis have a high incidence of urinary tract infections, report researchers. [More]
Incontinence prophylaxis shows potential in pelvic organ prolapse

Incontinence prophylaxis shows potential in pelvic organ prolapse

Research from Taiwan suggests that combining trocar-guided transvaginal mesh surgery with a midurethral sling in the treatment of women with advanced pelvic organ prolapse could be an effective way to manage associated stress urinary incontinence. [More]
Addressing antibiotic resistance: an interview with Professor Otto Cars, Uppsala University, Sweden

Addressing antibiotic resistance: an interview with Professor Otto Cars, Uppsala University, Sweden

Antibiotic resistance is a consequence of antibiotic use. Bacteria adapt to the threat of antibiotics using mechanisms to overcome the drug. These bacteria, which we call resistant bacteria, then survive. [More]
Key role for Fusobacterium adhesin in non-orthodontic periodontal inflammation

Key role for Fusobacterium adhesin in non-orthodontic periodontal inflammation

Researchers from China have found that patients with gingivitis and periodontitis are more likely to have Fusobacterium nucleatum carrying the novel Fusobacterium adhesin A than periodontally healthy people. [More]
FDA approves Miltenyi Biotec's CliniMACS CD34 Reagent System for prevention of GVHD

FDA approves Miltenyi Biotec's CliniMACS CD34 Reagent System for prevention of GVHD

Miltenyi Biotec announced today that the U.S. Food and Drug Administration has approved the company's CliniMACS CD34 Reagent System as a Humanitarian Use Device for the prevention of graft-versus-host disease in patients with acute myeloid leukemia in first complete remission undergoing allogeneic stem cell transplantation from a matched related donor. [More]

CECAD professor receives Prof Pushpa Talwar Memorial Oration for exceptional excellence in medical mycology

Prof Cornely heads the Clinical Trials Center and the Translational Research Platform at the CECAD Excellence Cluster at the University of Cologne. In addition to his research activities, as a senior physician at the Clinic I of Internal Medicine of the Cologne University Hospital he is responsible for clinical therapies for mycological infections. [More]

Meridian's TRU FLU assay gets FDA clearance for analytical sensitivity claim for avian Influenza H7N9 strain

Meridian Bioscience, Inc. today announced that the company's TRU FLU assay received FDA clearance for an analytical sensitivity claim for the novel avian Influenza H7N9 strain, A/Anhui/1/2013. TRU FLU is a rapid immunoassay that detects influenza A and influenza B viruses in 15 minutes in human respiratory specimens. [More]