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Nexavar does not meet primary endpoint in Phase 3 NExUS trial for advanced NSCLC

Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. today announced that the final analysis of the Phase 3 NExUS (NSCLC research Experience Utilizing Sorafenib) trial evaluating Nexavar® (sorafenib) tablets in patients with advanced non-squamous non-small cell lung cancer (NSCLC) showed that the study did not meet its primary endpoint of improving overall survival in the first-line setting.

14 Jun 2010

Telmisartan reduces hypertension, cardiovascular risk in ACE-intolerant patients: Boehringer Ingelheim

Telmisartan, an angiotensin receptor blocker, is one of the best researched drugs worldwide. It has been studied in clinical trials in more than 50,000 patients. Its positive safety profile has been confirmed also in a market exposure of 34.5 million patient years. Convincing safety data for patients with a high cardiovascular risk were collected in the three long-term outcome trials ONTARGET, PRoFESS and TRANSCEND which followed some of the patients for up to five years.

14 Jun 2010

Phase 2b RESTORE-CLI clinical trial in patients with CLI reaches statistical significance

Richard J. Powell, M.D., section chief of vascular surgery at the Dartmouth-Hitchcock Medical Center in Lebanon, NH and a principal investigator of the U.S. Phase 2b RESTORE-CLI clinical trial sponsored by Aastrom Biosciences, will present the full results from the interim analysis at today's session of the annual meeting of the Society for Vascular Surgery.

11 Jun 2010

Otonomy completes $10 million Series A financing with Avalon Ventures

Otonomy, Inc. announced today that it has completed a $10 million Series A financing with Avalon Ventures. Proceeds from the financing will be used to support the ongoing clinical trial for OTO-104 in Meniere's disease, initiate IND-enabling studies for OTO-203, and continue early-stage development of a third program.

11 Jun 2010

AVEO Pharmaceuticals presents tivozanib’s Phase 2 trial data at ASCO meeting

AVEO Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced data from a subgroup analysis of a Phase 2 randomized discontinuation trial showing that the median progression-free survival (PFS) achieved by patients with advanced clear cell renal cell carcinoma (RCC) who had undergone a prior nephrectomy was 14.8 months.

11 Jun 2010

Repros receives FDA confirmation on lifting of full clinical hold on Proellex

Repros Therapeutics Inc. today announced it has received written confirmation from the FDA noting the full clinical hold on Proellex® has been lifted. The Company will be allowed to run a single study under the new partial clinical hold status. The new low dose study is designed to explore both safety and signals of efficacy in an escalating dose fashion.

11 Jun 2010

Helix BioPharma third-quarter revenues increase 20.6%

Helix BioPharma Corp. today announced financial results for the third quarter ended April 30, 2010.

11 Jun 2010

FDA advisory committee recommends approval of Novartis' FTY720 for relapsing MS

Today, an advisory committee of the US Food and Drug Administration (FDA) recommended approval of FTY720 (fingolimod) for the treatment of patients with relapsing multiple sclerosis, the most common form of the disease. The FDA has the option of seeking the advice of one of its advisory committees as it reviews and decides whether to approve a new treatment. The committee voted unanimously that FTY720 demonstrated substantial efficacy in treating relapsing remitting MS and that safety of the proposed 0.5 mg dose justified approval.

11 Jun 2010

Idenix initiates IDX320 proof-of-concept study for HCV infection

Idenix Pharmaceuticals, Inc., a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced that it has initiated a 3-day proof-of-concept study of IDX320, a protease inhibitor for the treatment of hepatitis C virus (HCV) infection, under a Clinical Trial Application (CTA). The study is evaluating IDX320 in treatment-naive hepatitis C genotype 1-infected patients.

10 Jun 2010

Raw and cooked gingers reduce pain associated with muscle injury by 24%: Reed's

Reed's, Inc., maker of the top-selling sodas in natural food stores nationwide, commented today on a recent study in The Journal of Medicine that both raw and cooked ginger reduce pain associated with muscle injury by about 24%, compared with placebo. The study was supported by the McCormick Science Institute.

10 Jun 2010

Human Genome Sciences submits BLA for BENLYSTA to FDA

Human Genome Sciences, Inc. today announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval to market BENLYSTA® (belimumab) for the treatment of systemic lupus erythematosus (SLE).

10 Jun 2010

Aeterna Zentaris reports final results on clinical activity of perifosine for metastatic colorectal cancer

Aeterna Zentaris Inc., a late-stage drug development company specialized in oncology and endocrine therapy, today reported final results on the clinical activity of perifosine (KRX-0401), the Company's novel, potentially first-in-class, oral anticancer agent that inhibits Akt activation in the phosphoinositide 3-kinase pathway, in combination with capecitabine (Xeloda) as a treatment for advanced, metastatic colorectal cancer.

10 Jun 2010

CoLucid's lasmiditan NAAMA effective in treatment of acute migraine attacks

CoLucid Pharmaceuticals, Inc.,, an innovative biotechnology company focusing on therapies for central nervous system disorders, today announced that its investigational first-in-class Neurally Acting Anti-Migraine Agent (NAAMA), lasmiditan (also known as COL-144), a selective 5-HT1F receptor agonist, was effective when given orally to treat acute migraine attacks, as documented in a Phase IIb study.

10 Jun 2010

Regeneron's ARCALYST prevents gout attacks in Phase 3 study of patients initiating allopurinol therapy

Regeneron Pharmaceuticals, Inc. announced that a Phase 3 study in gout patients initiating allopurinol therapy to lower their uric acid levels showed that ARCALYST (rilonacept), also known as IL-1 Trap, prevented gout attacks, as measured by the primary endpoint of the number of gout flares per patient over the 16 week treatment period.

9 Jun 2010

Interim results from PROPEL study of RG7128 submitted as abstract to AASLD for Annual Liver Meeting

Pharmasset, Inc. announced today that the interim results from the PROPEL study conducted by its partner Roche demonstrate that RG7128 triple combination therapy was safe and well tolerated. In that study, the safety profile of RG7128 (1000mg BID or 500mg BID), when administered for 8 or 12 weeks with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin), the standard of care, was similar to the safety profile of SOC alone.

9 Jun 2010

First clinical trial among African women to test vaginal ring that prevents HIV transmission

The nonprofit International Partnership for Microbicides today announced the initiation of the first trial among women in Africa testing a vaginal ring containing an antiretroviral drug that could one day be used to prevent HIV transmission during sex. The clinical trial, known as IPM 015, tests the safety and acceptability of an innovative approach that adapts a successful technology from the reproductive health field to give women around the world a tool to protect themselves from HIV infection.

9 Jun 2010

Repligen's fiscal 2010 total revenue decreases to $20,971,000

Repligen Corporation today reported results for the fourth quarter and fiscal year 2010, ended March 31, 2010. Total revenue for the year was $20,971,000 compared to total revenue of $29,362,000 for fiscal year 2009 ended March 31, 2009.

9 Jun 2010

Discovery Labs reports preliminary results from Surfaxin Phase 2 trial in children with Acute Respiratory Failure

Discovery Laboratories, Inc., reports preliminary results from its Phase 2 clinical trial of Surfaxin® in children with Acute Respiratory Failure (ARF), a critical condition often caused in children by severe respiratory infections. The objective of the study was to evaluate the safety and tolerability of intratracheal administration of Surfaxin and to assess whether Surfaxin treatment could decrease the duration of mechanical ventilation in children with ARF.

9 Jun 2010

Update on Phase II clinical study of CH-4051 in rheumatoid arthritis

Chelsea Therapeutics International, Ltd. announced that during a teleconference yesterday, the U.S. Food and Drug Administration requested that the company delay the initiation of its proposed Phase II clinical study of CH-4051 in rheumatoid arthritis and indicated that the agency is requesting additional detail from the preclinical studies previously submitted as part of the company's investigational new drug application.

9 Jun 2010

Blood vessel-blocking drug slows prostate cancer progression: Experts

A blood vessel-blocking drug called tasquinimod slowed the rate of disease progression in a clinical trial of 200 prostate cancer patients, according to experts at Johns Hopkins, Roswell Park Cancer Institute and Duke University.

9 Jun 2010

Placebo News and Research

Nexavar does not meet primary endpoint in Phase 3 NExUS trial for advanced NSCLC

Telmisartan reduces hypertension, cardiovascular risk in ACE-intolerant patients: Boehringer Ingelheim

Phase 2b RESTORE-CLI clinical trial in patients with CLI reaches statistical significance

Otonomy completes $10 million Series A financing with Avalon Ventures

AVEO Pharmaceuticals presents tivozanib’s Phase 2 trial data at ASCO meeting

Repros receives FDA confirmation on lifting of full clinical hold on Proellex

Helix BioPharma third-quarter revenues increase 20.6%

FDA advisory committee recommends approval of Novartis' FTY720 for relapsing MS

Idenix initiates IDX320 proof-of-concept study for HCV infection

Raw and cooked gingers reduce pain associated with muscle injury by 24%: Reed's

Human Genome Sciences submits BLA for BENLYSTA to FDA

Aeterna Zentaris reports final results on clinical activity of perifosine for metastatic colorectal cancer

CoLucid's lasmiditan NAAMA effective in treatment of acute migraine attacks

Regeneron's ARCALYST prevents gout attacks in Phase 3 study of patients initiating allopurinol therapy

Interim results from PROPEL study of RG7128 submitted as abstract to AASLD for Annual Liver Meeting

First clinical trial among African women to test vaginal ring that prevents HIV transmission

Repligen's fiscal 2010 total revenue decreases to $20,971,000

Discovery Labs reports preliminary results from Surfaxin Phase 2 trial in children with Acute Respiratory Failure

Update on Phase II clinical study of CH-4051 in rheumatoid arthritis

Blood vessel-blocking drug slows prostate cancer progression: Experts

Advancing Neuroscience Research Through Collaboration and Patient-Centered Innovation

The impact of vibration on microscopy

How Omics Technologies Are Transforming Biological Research and Drug Discovery

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