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Santarus commences enrollment in rifamycin SV MMX Phase III clinical program for travelers' diarrhea

Santarus, Inc., a specialty biopharmaceutical company, today announced that is has begun to enroll patients in the first study in its Phase III clinical program to evaluate the efficacy and safety of rifamycin SV MMX® for the treatment of patients with travelers' diarrhea.

2 Jun 2010

Phase 3 pivotal REVIVE study data of VIVUS' avanafil for ED presented at 2010 AUA

VIVUS, Inc. today announced that data from the previously reported phase 3 pivotal REVIVE (TA-301) study, evaluating the safety and efficacy of the investigational drug avanafil for the treatment of erectile dysfunction (ED), were presented at the American Urological Association (AUA) 2010 Annual Meeting.

2 Jun 2010

FDA approves Prolia for postmenopausal women with osteoporosis

The U.S. Food and Drug Administration approved Prolia, an injectable treatment for postmenopausal women with osteoporosis who are at high risk for fractures.

2 Jun 2010

Protox announces presentations on PRX302 for BPH at 2010 AUA Annual Meeting

Protox Therapeutics Inc., a leader in the development of receptor targeted fusion proteins, today announced that two oral podium presentations on the company's lead candidate, PRX302, will be made at the 2010 Annual Meeting of the American Urological Association (AUA). These presentations will include six month data from the Phase 2b clinical study of PRX302 called TRIUMPH, in patients with moderate to severe benign prostatic hyperplasia (BPH).

1 Jun 2010

Belgian FAMHP approves Oncolytics' Phase 3 combination trial of REOLYSIN in head and neck cancers

Oncolytics Biotech Inc. today announced that it has received approval from the Belgian Federal Agency for Medicines and Health Products (FAMHP) to conduct its Phase 3 trial examining REOLYSIN in combination with paclitaxel and carboplatin in patients with platinum-refractory head and neck cancers. This is the same trial that was agreed to by U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process and the U.K. Medicines and Healthcare products Regulatory Agency (MHRA).

1 Jun 2010

BioCryst to commence Phase 2 study of BCX4208 alone and in combination with allopurinol in gout patients

BioCryst Pharmaceuticals, Inc. announced it is initiating a Phase 2 study of BCX4208 alone and in combination with allopurinol in patients with gout. BioCryst recently reported positive results from part one of its Phase 2 monotherapy study of BCX4208 in patients with gout and is now moving forward as planned with an additional Phase 2 trial of BCX4208.

1 Jun 2010

Shionogi Pharma presents data on PSD502 pivotal studies for primary premature ejaculation at 2010 AUA

Shionogi Pharma, Inc., a U.S.-based group company of Shionogi & Co., Ltd., today presented data summarizing the results of two pivotal studies of the investigational new drug PSD502, a topical metered dose spray being developed for the treatment of primary premature ejaculation (PE). These data were presented at the 2010 American Urological Association (AUA) Annual Meeting in San Francisco.

1 Jun 2010

Dendreon announces data presentation from 4 PROVENGE clinical trials at 105th AUA annual meeting

Dendreon Corporation today announced the presentation of safety data from the integrated analysis of four randomized PROVENGE® (sipuleucel-T) clinical trials of an autologous cellular immunotherapy in prostate cancer at the 105th Annual Scientific Meeting of the American Urological Association (AUA) in San Francisco.

1 Jun 2010

FAIR-HF study: Ferinject improves renal function in patients with CHF and iron deficiency

Results of a subanalysis from the FAIR-HF study demonstrate that correcting iron deficiency with Ferinject (ferric carboxymaltose) can improve renal function in chronic heart failure patients. Ferinject is an intravenous iron product used to treat iron deficiency and iron deficiency anaemia.

From CSL Ltd 31 May 2010

Celladon announces 6-month data from Phase 2 clinical trial of MYDICAR in advanced heart failure patients

Celladon Corp., a biopharmaceutical company focused on the discovery and development of innovative treatments for cardiovascular diseases, today announced that six-month data from its Phase 2 clinical trial of MYDICAR® show improvements in clinical outcomes and disease markers in advanced heart failure patients treated with the genetically targeted enzyme replacement therapy.

31 May 2010

Targeted Genetics's partner Celladon presents Phase II trial data with MYDICAR at Heart Failure Congress 2010

Targeted Genetics Corporation announced that its partner, Celladon Corporation, presented full data today that show the first Phase II trial with MYDICAR® for the treatment of advanced heart failure has met its primary safety and efficacy endpoints, as prospectively defined in the Phase II trial protocol.

31 May 2010

RNAi therapy shuts down gene critical to RSV, prevents virus replication

John DeVincenzo, MD, professor and researcher in the Departments of Pediatrics and Molecular Sciences at the University of Tennessee Health Science Center (UTHSC), has proven for the first time that a totally new concept in drug design can be used to treat human disease. Dr. DeVincenzo, who also serves as a children's infectious diseases specialist at Le Bonheur Children's Hospital, conducted his study at the Children's Foundation Research Center, a UT Health Science Center partner located at Le Bonheur.

29 May 2010

Bioheart to establish two Centers of Excellence to provide cell therapy procedures for patients with CHF, PAD

Bioheart, Inc., announced today plans for establishing two Centers of Excellence in the Middle East to provide its cell therapy procedures to patients suffering from congestive heart failure and peripheral arterial disease. Dr. Karl E. Groth, Chairman and CEO, and Peggy A. Farley, Chief Operating and Financial Officer, are now in that region holding discussions and performing site inspections.

29 May 2010

Advaxis doses first patient in FDA-approved phase II CIN trial

Advaxis, Inc., the live, attenuated Listeria monocytogenes biotechnology company, has dosed the first patient in its US Food and Drug Administration -approved, phase II clinical trial in cervical intraepithelial neoplasia, commonly known as cervical dysplasia.

28 May 2010

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

Placebo News and Research

Santarus commences enrollment in rifamycin SV MMX Phase III clinical program for travelers' diarrhea

Phase 3 pivotal REVIVE study data of VIVUS' avanafil for ED presented at 2010 AUA

FDA approves Prolia for postmenopausal women with osteoporosis

Protox announces presentations on PRX302 for BPH at 2010 AUA Annual Meeting

Belgian FAMHP approves Oncolytics' Phase 3 combination trial of REOLYSIN in head and neck cancers

BioCryst to commence Phase 2 study of BCX4208 alone and in combination with allopurinol in gout patients

Shionogi Pharma presents data on PSD502 pivotal studies for primary premature ejaculation at 2010 AUA

Dendreon announces data presentation from 4 PROVENGE clinical trials at 105th AUA annual meeting

FAIR-HF study: Ferinject improves renal function in patients with CHF and iron deficiency

Celladon announces 6-month data from Phase 2 clinical trial of MYDICAR in advanced heart failure patients

Targeted Genetics's partner Celladon presents Phase II trial data with MYDICAR at Heart Failure Congress 2010

RNAi therapy shuts down gene critical to RSV, prevents virus replication

Bioheart to establish two Centers of Excellence to provide cell therapy procedures for patients with CHF, PAD

Advaxis doses first patient in FDA-approved phase II CIN trial

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

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

Advancing Intracellular Delivery with LumiPore®

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