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VIVUS to present phase 3 data on avanafil for treatment of ED at AUA 2010

VIVUS, Inc. today announced that phase 3 data on avanafil, a next generation oral phosphodiesterase type 5 inhibitor therapy being investigated for the treatment of erectile dysfunction, will be presented next Tuesday at the American Urological Association 2010 Annual Meeting in San Francisco, California.

28 May 2010

CSL Behring granted authorization to market Berinert for HAE in Italy and Luxembourg

CSL Behring announced today it has been granted national marketing authorization in Italy and Luxembourg to market Berinert® for the treatment of acute hereditary angioedema (HAE) attacks in any body location. This latest authorization brings the number of countries to 28 (in Europe, Asia, North America, South America and Australia) in which Berinert is now licensed.

28 May 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

Pfizer plans recruitment halt to EMPHASIS-HF trial

Pfizer Inc. announced that it plans to halt recruitment to the EMPHASIS-HF trial early on the recommendations of the trial's independent Executive Steering Committee (ESC). The recommendations follow a second interim analysis by the independent Data Safety Monitoring Committee (DSMC) of the EMPHASIS-HF trial confirming the study has reached its primary efficacy endpoint early according to the protocol pre-defined stopping rules.

27 May 2010

Shark cartilage extract shows no benefit for patients with advanced non-small cell lung cancer

In the first scientific study of its kind, shark cartilage extract, AE-941 or Neovastat, has shown no benefit as a therapeutic agent when combined with chemotherapy and radiation for patients with advanced non-small cell lung cancer, according to researchers at The University of Texas MD Anderson Cancer Center.

27 May 2010

Study demonstrates efficacy of CONCERTA in treating ADHD in presence of comorbid learning disability

Turning in assignments, following instructions and focusing on learning something new are among the daily classroom challenges for children with Attention Deficit Hyperactivity Disorder (ADHD), according to the National Institute of Mental Health (NIMH). New data presented today show efficacy of CONCERTA® (OROS® methylphenidate HCl Extended-Release Tablets CII) on ADHD symptoms in children with the condition who also may face other specific challenges.

26 May 2010

Ambrotose AO capsules raise antioxidant protection in serum ORAC in healthy adults: Study

Mannatech, Incorporated, a global pioneer in the development of high-quality health, weight and fitness, and skin care solutions based on nutritional science, announced the results of an independent human clinical study that demonstrated intake of its proprietary Ambrotose AO capsules raised antioxidant protection in serum oxygen radical absorbance capacity in healthy adults, further validating a previous human study.

26 May 2010

Shire announces study results of Vyvanse Capsules CII for treatment of ADHD in adolescents

Shire plc, the global specialty biopharmaceutical company, today announced the results of a study evaluating the safety and efficacy of Vyvanse (lisdexamfetamine dimesylate) Capsules CII for the treatment of Attention Deficit Hyperactivity Disorder in adolescents aged 13 to 17 years.

26 May 2010

Positive results reported from Phase IIa clinical trial of intranasal oxytocin for CDH

Trigemina, Inc., a Mountain View based privately-held biopharmaceutical company, reports positive results from a time-based interim analysis of its Phase IIa clinical trial in Chronic Daily Headache. The trial is a collaborative effort between Trigemina and Dr. Egilius Spierings of MedVadis Research Corporation located outside of Boston. The study compares intranasal oxytocin with placebo in patients suffering from CDH.

26 May 2010

Targeted enrollment in Phase IIb trial for EpiCept NP-1 in CPN attained: EpiCept

EpiCept Corporation today announced that the targeted enrollment in a Phase IIb trial for EpiCept NP-1 in chemotherapy-induced peripheral neuropathy has been attained. The trial is being conducted by National Cancer Institute -funded Community Clinical Oncology Program.

26 May 2010

GTx reports top line results from toremifene Phase III clinical trial for prostate cancer

GTx, Inc. today announced top line results of the Phase III clinical trial evaluating toremifene 20 mg, a selective estrogen receptor modulator, for the prevention of prostate cancer in men with high grade prostatic intraepithelial neoplasia, or PIN, a premalignant lesion of the prostate.

26 May 2010

FDA grants priority review for Alkermes' VIVITROL sNDA for opioid dependence

Alkermes, Inc. today announced that the supplemental New Drug Application (sNDA) for VIVITROL® (naltrexone for extended-release injectable suspension) for opioid dependence has been designated a priority review by the U.S. Food and Drug Administration (FDA).

25 May 2010

DMC recommends ARIAD continue Phase 3 trial of oral ridaforolimus for metastatic sarcomas to final analysis

ARIAD Pharmaceuticals, Inc. today announced that the independent Data Monitoring Committee (DMC) of the Phase 3 SUCCEED trial has completed the second interim efficacy analysis as specified in the study protocol and has recommended that the randomized, placebo-controlled trial of oral ridaforolimus in patients with metastatic sarcomas continue to its final analysis, without modification to the study protocol.

25 May 2010

DAPT Study expands into seven countries in the EU: HCRI

The Harvard Clinical Research Institute announced today that the DAPT Study has expanded into seven countries in the European Union. John Irving, MBChB, MRCP, M.D., consultant cardiologist at Ninewells Hospital in Dundee, United Kingdom, was the first European investigator to enroll patients into the study.

25 May 2010

Thymosin beta 4 reduces brain tissue damage, improves brain function in rats: Research paper

RegeneRx Biopharmaceuticals, Inc. announced today that in a preclinical research paper published in the May 2010 issue of the Journal of Neurosurgery, (online ahead of publication), scientists found that the systemic administration of thymosin beta 4, or Tβ4, significantly reduced brain tissue damage and improved brain function in rats with traumatic brain injury, or TBI.

24 May 2010

Filing of Clinical Data's NDA for vilazodone accepted for FDA review

Clinical Data, Inc., today announced that the U.S. Food and Drug Administration has accepted for filing the Company's New Drug Application for vilazodone for the treatment of major depressive disorder.

24 May 2010

Lytix Biopharma receives approval to initiate Phase I/IIa clinical trial of Lytixar for MRSA

The Norwegian pharmaceutical company Lytix Biopharma AS today announces the approval by the Swedish Medical Products Agency to commence a Phase I/IIa clinical trial with Lytixar (LTX-109) for nasal decolonisation of MRSA.

24 May 2010

New findings on INTUNIV Extended Release Tablets presented at major psychiatric meeting

Shire plc, the global specialty biopharmaceutical company, today announced new findings on once-daily INTUNIV (guanfacine) Extended Release Tablets, the first selective alpha-2A agonist approved for the treatment of Attention Deficit Hyperactivity Disorder, at a major psychiatric meeting.

24 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

Researchers test NicVAX vaccine to help people quit smoking, avoid relapses

In a unique twist to a decades-old health crisis, Michigan State University researchers are testing a new vaccine to help people quit smoking and avoid relapses.

21 May 2010

Placebo News and Research

VIVUS to present phase 3 data on avanafil for treatment of ED at AUA 2010

CSL Behring granted authorization to market Berinert for HAE in Italy and Luxembourg

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

Pfizer plans recruitment halt to EMPHASIS-HF trial

Shark cartilage extract shows no benefit for patients with advanced non-small cell lung cancer

Study demonstrates efficacy of CONCERTA in treating ADHD in presence of comorbid learning disability

Ambrotose AO capsules raise antioxidant protection in serum ORAC in healthy adults: Study

Shire announces study results of Vyvanse Capsules CII for treatment of ADHD in adolescents

Positive results reported from Phase IIa clinical trial of intranasal oxytocin for CDH

Targeted enrollment in Phase IIb trial for EpiCept NP-1 in CPN attained: EpiCept

GTx reports top line results from toremifene Phase III clinical trial for prostate cancer

FDA grants priority review for Alkermes' VIVITROL sNDA for opioid dependence

DMC recommends ARIAD continue Phase 3 trial of oral ridaforolimus for metastatic sarcomas to final analysis

DAPT Study expands into seven countries in the EU: HCRI

Thymosin beta 4 reduces brain tissue damage, improves brain function in rats: Research paper

Filing of Clinical Data's NDA for vilazodone accepted for FDA review

Lytix Biopharma receives approval to initiate Phase I/IIa clinical trial of Lytixar for MRSA

New findings on INTUNIV Extended Release Tablets presented at major psychiatric meeting

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

Researchers test NicVAX vaccine to help people quit smoking, avoid relapses

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