Prophylaxis News and Research

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FDA grants Cepheid marketing clearance for Xpert SA Nasal Complete molecular test

Cepheid today announced it has received clearance from the U.S. Food & Drug Administration (FDA) to market Xpert® SA Nasal Complete, the first and only molecular test designed for the simultaneous detection and differentiation of both Staphylococcus aureus (SA) and Methicillin-resistant Staphylococcus aureus (MRSA) colonization in less than one hour. The test runs on Cepheid's GeneXpert® System, the world's leading molecular platform for accuracy, speed, and ease-of-use.

8 Jun 2010

OXiGENE reports positive final data from Phase 1 study of OXi4503 in patients with solid tumors

OXiGENE, Inc., a clinical-stage, biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases, announced today that in collaboration with OXiGENE, Professor Gordon Rustin and colleagues from the Mount Vernon Cancer Research Centre, UK and other institutions in the United Kingdom, reported positive final data from an investigator-sponsored Phase 1 study of OXi4503 in patients with solid tumors.

7 Jun 2010

Novartis' Afinitor decreases size of SEGAs associated with tuberous sclerosis

Novartis Pharmaceuticals Corporation announced today that results from a Phase II study show Afinitor® (everolimus) tablets is the first medication in a clinical trial to decrease the size of subependymal giant cell astrocytomas (SEGAs), benign brain tumors associated with tuberous sclerosis (TS). In this study of 28 patients presented today at the 46th American Society of Clinical Oncology (ASCO) annual meeting in Chicago, 75% of patients experienced a reduction of 30% or greater in the size of their brain tumors from baseline to six months (p<0.001).

7 Jun 2010

Phase III study of Afinitor tablets in patients with advanced pancreatic NET meets primary endpoint

Novartis Pharmaceuticals Corporation announced today that a Phase III study of Afinitor (everolimus) tablets plus best supportive care met its primary endpoint, showing the drug significantly extended progression-free survival, or time without tumor growth, in patients with advanced pancreatic neuroendocrine tumors.

3 Jun 2010

Use of lubricants with anal sex associated with increased risk of rectal sexually transmitted infections

The risk of acquiring HIV through unprotected anal sex is at least 20 times greater than with unprotected vaginal sex and increases if other infections are already present in the rectal lining. Could the use of lubricants - at least certain kinds - be another risk factor among men and women who engage in receptive anal intercourse? Two studies presented today at the International Microbicides Conference in Pittsburgh, suggest the answer is yes.

27 May 2010

Researchers present more findings for microbicides, prep at M2010 conference

Researchers on Monday at the International Microbicides Conference in Pittsburgh continued to present data on HIV prevention research, Reuters reports. The news service outlines several prevention methods being researched, including an intravaginal ring that over time releases two antiretrovirals - dapivirine and maraviroc - for up to a month, and a vaginal tablet that time-releases the antiretrovirals dapivirine and DS003 for up to 12 hours.

26 May 2010

Research on new types of anti-HIV drugs presented at International Microbicides Conference

Researchers testing a vaginal microbicide based on a new type of anti-HIV drug found it provided monkeys significant protection against infection with a virus similar to HIV, according to a study reported at the International Microbicides Conference in Pittsburgh today.

24 May 2010

Dr. Reddy's Laboratories launches tacrolimus capsules in the US market

Dr. Reddy's Laboratories today announced that it has launched tacrolimus capsules, (0.5mg, 1mg, 5mg), a bioequivalent generic version of Prograf Capsules, in the US market on May 20, 2010. The United States Food & Drug Administration granted an approval of Dr. Reddy's ANDA for tacrolimus capsules on May 13, 2010.

21 May 2010

Vesicoureteral reflux more common among girls

Children with vesicoureteral reflux (VUR), in which urine flows backwards into the kidneys from the bladder, have been treated in the past with surgery or antibiotic therapy.

21 May 2010

Clinical Infectious Diseases journal examines new scientific advances to curb HIV, TB epidemics

As US policymakers consider scaling back on its historic initiative to fight AIDS around the world and downsizing goals to combat tuberculosis, next-generation treatment and prevention strategies to significantly reduce the spread of HIV/AIDS and tuberculosis are now imminent. New science can dramatically change the trajectory of both deadly epidemics, according to a special new issue of the journal Clinical Infectious Diseases.

21 May 2010

AP examines HIV microbicides, prep research

"Try after try to make vaginal creams that could repel the AIDS virus have failed. Now researchers are testing if a drug used to treat HIV infection finally might give women a tool to prevent it - by infusing the medicine into vaginal gels and contraceptive-style rings," the Associated Press reports in a piece that examines researchers' latest efforts to create effective HIV microbicides, ahead of the biennial International Microbicides Conference next weekend.

19 May 2010

Thai AIDS vaccine trial: Risk of HIV infection can be reduced with a vaccine

For more than a decade, researchers and advocates have marked HIV Vaccine Awareness Day with varying degrees of hope, cynicism and despair. This year, in large part because of the results of the Thai Prime-Boost vaccine study, there is greater cause for hope than ever before and a renewed sense of urgency to transform this hope into a reality.

18 May 2010

Final data from Open-Label studies of Cinryze in patients with HAE now available

ViroPharma Incorporated today announced the availability of final data from Open-Label studies of Cinryze (C1 Esterase Inhibitor [Human]) in preventing and treating attacks of hereditary angioedema on the U.S. National Institutes of Health's online clinical trial registry, www.clinicaltrials.gov.

18 May 2010

Health Canada grants Response Biomedical Class 3 Medical Device license for RAMP RSV Assay

Response Biomedical Corporation today announced that it has been granted a Class 3 (near patient/point-of-care) Medical Device license by Health Canada to market its RAMP® Respiratory Syncytial Virus (RSV) Assay in Canada.

18 May 2010

Risk of venous thromboembolism is low after hepatic resection in cirrhotic patients: Researchers

Hepatocellular carcinoma is the most common primary neoplasm of the liver and often arises in the context of a chronic liver disease that impairs coagulative function. Surgical resection is the best option to cure HCC, however, surgery on cirrhotic liver may increase the risk of bleeding.

12 May 2010

Pfizer presents data on in vivo activity of PF-04523655 siRNA drug candidate at ARVO annual meeting

Quark Pharmaceuticals, Inc., the world leader in clinical development of RNAi-based therapeutics, announced today that researchers from Pfizer, Inc. presented data on in vivo activity of PF-04523655 at the Association for Research in Vision and Ophthalmology (ARVO) annual meeting, being held May 2-6, 2010 in Fort Lauderdale.

7 May 2010

Aeterna Zentaris granted FDA orphan-drug designation for AEZS-108 in ovarian cancer

Aeterna Zentaris Inc. a late-stage drug development company specialized in oncology and endocrinology, today announced that it has received from the U.S. Food and Drug Administration (FDA), orphan-drug designation for AEZS-108, its doxorubicin targeted conjugate compound, for the treatment of ovarian cancer. AEZS-108 is currently in a Phase 2 trial in advanced ovarian and advanced endometrial cancer in Europe.

6 May 2010

Phase II trial: TB-402 demonstrates superior antithrombotic activity to enoxaparin

BioInvent International AB and ThromboGenics NV announce today positive results from their Phase II trial of TB-402. TB-402 is a novel, long acting anticoagulant that is being developed as a single injection for the prevention of venous thromboembolism following orthopaedic surgery.

6 May 2010

ThromboGenics, BioInvent International report positive results from Phase II trial of TB-402 for VTE

ThromboGenics NV and co-development partner BioInvent International announce today positive results from their Phase II trial of TB-402. TB-402 is a novel, long acting anticoagulant that is being developed as a single injection for the prevention of venous thromboembolism (VTE) following orthopaedic surgery.

6 May 2010

Quark to present poster on predicting risk of DGF following machine perfusion of renal transplants at ATC 2010

Quark Pharmaceuticals, Inc., the world leader in clinical development of RNAi-based therapeutics, announced today the presentation of a poster at the 2010 American Transplant Congress titled, "A Nomogram for Predicting Risk of Delayed Graft Function Following Machine Perfusion of Renal Transplants."

5 May 2010

Prophylaxis News and Research

FDA grants Cepheid marketing clearance for Xpert SA Nasal Complete molecular test

OXiGENE reports positive final data from Phase 1 study of OXi4503 in patients with solid tumors

Novartis' Afinitor decreases size of SEGAs associated with tuberous sclerosis

Phase III study of Afinitor tablets in patients with advanced pancreatic NET meets primary endpoint

Use of lubricants with anal sex associated with increased risk of rectal sexually transmitted infections

Researchers present more findings for microbicides, prep at M2010 conference

Research on new types of anti-HIV drugs presented at International Microbicides Conference

Dr. Reddy's Laboratories launches tacrolimus capsules in the US market

Vesicoureteral reflux more common among girls

Clinical Infectious Diseases journal examines new scientific advances to curb HIV, TB epidemics

AP examines HIV microbicides, prep research

Thai AIDS vaccine trial: Risk of HIV infection can be reduced with a vaccine

Final data from Open-Label studies of Cinryze in patients with HAE now available

Health Canada grants Response Biomedical Class 3 Medical Device license for RAMP RSV Assay

Risk of venous thromboembolism is low after hepatic resection in cirrhotic patients: Researchers

Pfizer presents data on in vivo activity of PF-04523655 siRNA drug candidate at ARVO annual meeting

Aeterna Zentaris granted FDA orphan-drug designation for AEZS-108 in ovarian cancer

Phase II trial: TB-402 demonstrates superior antithrombotic activity to enoxaparin

ThromboGenics, BioInvent International report positive results from Phase II trial of TB-402 for VTE

Quark to present poster on predicting risk of DGF following machine perfusion of renal transplants at ATC 2010

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