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Medivir reports 24-week interim Phase 2b results of TMC435 in treatment-naïve patients with HCV genotype-1

Medivir announced today 24-week end-of-treatment interim results from the 5-arm phase 2b response guided PILLAR study in 386 treatment-naïve patients with hepatitis C virus (HCV) genotype-1 (TMC435-C205).

12 Jul 2010

Report shows experimental trials have higher risk for bias

A Johns Hopkins review of nearly 150 randomized controlled trials on children - all published in well-regarded medical journals - reveals that 40 to 60 percent of the studies either failed to take steps to minimize risk for bias or to at least properly describe those measures.

12 Jul 2010

Study results show no improvement in overall survival for combination of gemcitabine and Amplimexon

AmpliMed Corporation, a cancer therapeutics company, today announced results from AMP-019, a randomized double-blind, placebo-controlled Phase II screening trial designed to determine if a Phase III trial was warranted for the combination of gemcitabine (Gemzar, Eli Lilly) plus Amplimexon (AmpliMed Corporation) in patients with advanced pancreatic ductal adenocarcinoma of the pancreas.

12 Jul 2010

Phase III study results of imiquimod creams for treatment of EGW presented at HPV Conference

Results from a Phase III program evaluating imiquimod 3.75% and 2.5% creams for the treatment of EGW, applied once daily for up to 8 weeks, demonstrated that both were well-tolerated and more efficacious than placebo, according to data presented at the annual Human Papillomavirus Conference in Montreal, July 3 - 8. Investigators found that efficacy was greatest for imiquimod 3.75% with an enhanced safety profile.

9 Jul 2010

Data shows potential health benefits of S-equol in relieving menopausal symptoms

The findings of a scientific conference examining the growing body of research and potential health benefits of S-equol were published this month in the Journal of Nutrition. Manuscripts based on presentations made at the conference, which was organized by the Life Sciences Research Office, reveal data that S-equol is a safe, natural and effective solution to providing relief of menopausal symptoms such as hot flashes and muscle discomfort.

9 Jul 2010

Patients with advanced Parkinson's disease prefer dopamine agonists, shows review

Of the three main types of oral drugs commonly added to levodopa therapy for patients with advanced Parkinson's disease, one might be the most effective, according to a new review.

9 Jul 2010

Bayer HealthCare to present BAY86-6150 rFVIIa Phase I clinical data at XXIX WFH International Congress

Phase I clinical data for BAY86-6150, a novel recombinant factor VIIa protein (rFVIIa) being developed by Bayer HealthCare, will be presented at the XXIX International Congress of the World Federation of Hemophilia (WFH) to be held in Buenos Aires, Argentina from Saturday, July 10-Wednesday, July 14.

9 Jul 2010

Fibrocell Science completes enrollment in azficel-T histology study

Fibrocell Science, Inc., a biotechnology company focused on the development of autologous cell therapies for aesthetic, medical and scientific applications, announced today the completion of enrollment of and first treatment visits for participants in its histology study (IT-H-001) of azficel-T. An autologous cell therapy, azficel-T is currently under review by the U.S. Food and Drug Administration for the treatment of moderate to severe nasolabial fold wrinkles.

8 Jul 2010

Nymox reports positive new results from pooled analysis of NX-1207 clinical trials for BPH

Nymox Pharmaceutical Corporation reported today positive new results from pooled analysis of completed clinical trials of NX-1207, the Company's investigational drug for BPH. The trial data shows that patients receiving NX-1207 recorded significant quantitative improvement in the important symptom of urgent need to urinate.

8 Jul 2010

GSK, XenoPort disappointed with GSK1838262/XP13512 phase 2b study for migraine headaches

GlaxoSmithKline and XenoPort, Inc. announced today that GSK1838262/XP13512 (gabapentin enacarbil) did not demonstrate a statistically significant improvement compared to placebo as a prophylactic treatment for migraine headaches. This phase 2b dose-ranging study evaluated the efficacy, safety and tolerability of GSK1838262 in adults diagnosed with migraine headache (with or without aura) according to the International Headache Society criteria.

8 Jul 2010

FDA approves Beech Tree Labs' IND for Phase 1/2a clinical evaluation of BTL-TML-HSV

Beech Tree Labs, Inc., announced today that the FDA has approved its IND for a Phase 1/2a clinical evaluation of BTL-TML-HSV, a novel therapeutic agent for treating recurrent oral herpes infections. The study will be a 210 patient, multi-site, placebo-controlled trial and is anticipated to begin later this summer.

8 Jul 2010

NOXXON to commence multiple ascending dose study of MCP-1 targeting anti-inflammatory Spiegelmer NOX-E36

NOXXON Pharma AG announced today that it has permission to commence a multiple ascending dose study of its Monocyte Chemoattractant Protein-1 (MCP-1) targeting anti-inflammatory Spiegelmer®, NOX-E36. NOXXON plans to develop NOX-E36 for the treatment of diabetic nephropathy and other diabetes related complications.

7 Jul 2010

Alnylam Pharmaceuticals initiates dosing in Phase I human clinical study with ALN-TTR01

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today it has initiated dosing in a Phase I human clinical study with ALN-TTR01. The study is aimed at evaluating the safety and tolerability of ALN-TTR01 in patients with transthyretin -mediated amyloidosis, and is also designed to provide preliminary data on human proof of concept based on measurements of TTR serum levels.

7 Jul 2010

Nile completes dosing in CD-NP Phase II study for acute decompensated heart failure

Nile Therapeutics, Inc., a biopharmaceutical company focused on the development of novel therapeutics for cardiovascular disease, today announced that it has completed the dosing of the last patient in NIL-CDNP-CT005, an open-label, single-blind, placebo-controlled Phase II study of CD-NP in patients with acute decompensated heart failure, or ADHF. The study was designed to provide additional information on the safety and tolerability of CD-NP when infused for up to 72 hours in patients with ADHF and mild to moderate renal insufficiency.

7 Jul 2010

ASPREE study aims to assess health benefits of aspirin

In an effort to extend the length of a disability-free life for older adults, researchers from Rush University Medical Center are partnering with colleagues from across the U.S. and Australia in the largest international trial ever sponsored by the National Institute on Aging.

7 Jul 2010

Extended treatment with blood thinner benefits patients immobilized by acute medical illness: Study

A treatment plan used to prevent potentially dangerous blood clots in recovering surgical patients can also benefit some patients immobilized by acute medical illness, doctors have found in a multi-institutional study.

7 Jul 2010

Initial Phase II study results of ofatumumab in patients with RRMS announced

Genmab A/S announced today positive interim results from an ofatumumab Phase II safety and pharmacokinetics study in patients with relapsing-remitting multiple sclerosis.

7 Jul 2010

Shire receives FDA approval of Daytrana for ADHD in adolescents

Shire plc, the global specialty biopharmaceutical company, announced the US Food and Drug Administration (FDA) approval of Daytrana® (methylphenidate transdermal system) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adolescents aged 13 to 17 years. Daytrana, the first and only transdermal ADHD patch, is already an FDA-approved ADHD treatment for children 6 to 12 years. Daytrana is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, and social).

7 Jul 2010

PuraMed BioScience completes clinical study of LipiGesic M for treating acute migraine

PuraMed BioScience, announced today that a clinical study of LipiGesic M has been completed. The study design was a double blind, placebo controlled, multi-site study measuring the effectiveness of LipiGesic™ M for the treatment of acute migraine attacks. The next steps include completion of the manuscript, submission for publication in a peer-reviewed medical journal and actual publication. In an effort to maximize the potential for publication, an embargo has been placed on the disclosure of any of the results of this study.

7 Jul 2010

Adeona completes $1 million equity financing and provides update on Zinthionein ZC clinical study

Adeona Pharmaceuticals, Inc., announced today that on July 6, 2010, it completed an equity financing of $1 million with a single institutional investor, Seaside 88, L.P. The financing involved the sale of 1,212,121 registered shares of common stock and no warrants. Enclave Capital served as placement agent and will receive a 7% cash commission and 5-year warrants to acquire 60,606 shares of Adeona at $1.32 per share. The use of proceeds is intended for general corporate purposes.

6 Jul 2010

Placebo News and Research

Medivir reports 24-week interim Phase 2b results of TMC435 in treatment-naïve patients with HCV genotype-1

Report shows experimental trials have higher risk for bias

Study results show no improvement in overall survival for combination of gemcitabine and Amplimexon

Phase III study results of imiquimod creams for treatment of EGW presented at HPV Conference

Data shows potential health benefits of S-equol in relieving menopausal symptoms

Patients with advanced Parkinson's disease prefer dopamine agonists, shows review

Bayer HealthCare to present BAY86-6150 rFVIIa Phase I clinical data at XXIX WFH International Congress

Fibrocell Science completes enrollment in azficel-T histology study

Nymox reports positive new results from pooled analysis of NX-1207 clinical trials for BPH

GSK, XenoPort disappointed with GSK1838262/XP13512 phase 2b study for migraine headaches

FDA approves Beech Tree Labs' IND for Phase 1/2a clinical evaluation of BTL-TML-HSV

NOXXON to commence multiple ascending dose study of MCP-1 targeting anti-inflammatory Spiegelmer NOX-E36

Alnylam Pharmaceuticals initiates dosing in Phase I human clinical study with ALN-TTR01

Nile completes dosing in CD-NP Phase II study for acute decompensated heart failure

ASPREE study aims to assess health benefits of aspirin

Extended treatment with blood thinner benefits patients immobilized by acute medical illness: Study

Initial Phase II study results of ofatumumab in patients with RRMS announced

Shire receives FDA approval of Daytrana for ADHD in adolescents

PuraMed BioScience completes clinical study of LipiGesic M for treating acute migraine

Adeona completes $1 million equity financing and provides update on Zinthionein ZC clinical study

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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