Prophylaxis News and Research

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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.

27 Mar 2014

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.

21 Mar 2014

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.

16 Mar 2014

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.

16 Mar 2014

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.

4 Mar 2014

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.

27 Feb 2014

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.

20 Feb 2014

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.

13 Feb 2014

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.

12 Feb 2014

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.

3 Feb 2014

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.

3 Feb 2014

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.

31 Jan 2014

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.

24 Jan 2014

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.

20 Jan 2014

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.

10 Jan 2014

Mylan announces launch of Mycophenolic Acid Delayed-release Tablets

Mylan Inc. today announced that its U.S.-based subsidiary Mylan Pharmaceuticals Inc. has launched Mycophenolic Acid Delayed-release Tablets, 180 mg and 360 mg. This product is the generic version of Novartis' Myfortic Delayed-release Tablets.

9 Jan 2014

Veloxis Pharmaceuticals seeks FDA approval to market Envarsus for prevention of organ rejection

Veloxis Pharmaceuticals A/S, today announced that it has submitted a New Drug Application to the U.S. Food and Drug Administration seeking approval for the marketing and sale of Envarsus (formerly LCP-Tacro) for the prevention of organ rejection in kidney transplant recipients.

30 Dec 2013

U.S. FDA grants Veloxis Orphan Drug status for Envarsus

Veloxis Pharmaceuticals A/S, today announced that Envarsus was granted Orphan Drug status by the U.S. Food and Drug Administration (FDA) for prophylaxis of organ rejection in patients receiving allogenic kidney transplants.

24 Dec 2013

Preoperative antibiotics within two hours of cardiac surgery decrease risk of developing SSIs

A new study found preoperative antibiotic therapy administered within two hours of cardiac surgery decreased the risk of developing surgical site infections (SSIs) significantly. The study was published in the January issue of Infection Control and Hospital Epidemiology, the journal of the Society for Healthcare Epidemiology of America.

23 Dec 2013

FDA approves Baxter's FEIBA for prophylactic treatment of hemophilia patients with inhibitors

Baxter International Inc. today announced that the United States Food and Drug Administration granted approval of Baxter's FEIBA [Anti-Inhibitor Coagulant Complex], the first and only FDA-approved treatment for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A or B who have developed inhibitors.

From Baxter International Inc. 20 Dec 2013