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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

Merck's MK-4305 improves overall sleep efficiency in primary insomnia patients

Clinical results from a Phase IIb study showed that MK-4305, Merck's investigational dual orexin receptor antagonist, was significantly more effective than placebo (p<0.005) in improving overall sleep efficiency at night one and at the end of week four in patients with primary insomnia. MK-4305 was generally well-tolerated in the study. Orexins are neuropeptides (chemical messengers) that are released by specialized neurons in the hypothalamus region of the brain and are believed to be an important regulator of the brain's sleep-wake process.

9 Jun 2010

Helix BioPharma reports Phase II clinical results of Topical Interferon Alpha-2b for ano-genital warts

Helix BioPharma Corp. today announced results from the Phase II clinical trial assessing the efficacy and safety of Topical Interferon Alpha-2b cream for the treatment of ano-genital warts (AGW).

9 Jun 2010

Lubiprostone phase 3 clinical trial in Japan for chronic idiopathic constipation meets primary endpoint

Sucampo Pharmaceuticals, Inc. and Abbott today announced that a pivotal phase 3 clinical trial of lubiprostone for chronic idiopathic constipation (CIC) in Japanese patients met its primary endpoint with statistical significance and demonstrated a safety profile consistent with previously reported clinical lubiprostone data.

9 Jun 2010

Aerovance reports top-line results from Aerovant Phase 2b clinical trial for eosinophilic asthma

Aerovance Inc. today announced top-line results from its Phase 2b clinical trial that show the inhaled dry powder formulation of Aerovant (pitrakinra inhalation powder) is effective in a pre-defined subset of patients with eosinophilic asthma.

8 Jun 2010

Phase 2 study results of Qnexa in patients with OSA presented at SLEEP 2010

VIVUS, Inc. today announced that data from a previously reported phase 2 study evaluating the safety and efficacy of the investigational drug Qnexa for the treatment of obstructive sleep apnea were presented at SLEEP 2010, the 24th Annual Meeting of the Associated Professional Sleep Societies.

8 Jun 2010

Columbia completes enrollment in PROCHIEVE 8% Phase III study to reduce preterm birth in short cervix women

Columbia Laboratories, Inc. today announced it completed enrollment in the PREGNANT (PROCHIEVE Extending GestatioN A New Therapy) Study last week. This randomized, double-blind, placebo controlled Phase III clinical study is evaluating the safety and efficacy of PROCHIEVE® 8% (progesterone gel) to reduce the risk of preterm birth in women with a cervical length between 1.0 and 2.0 centimeters as measured by transvaginal ultrasound at mid-pregnancy.

8 Jun 2010

Placebo News and Research

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

Merck's MK-4305 improves overall sleep efficiency in primary insomnia patients

Helix BioPharma reports Phase II clinical results of Topical Interferon Alpha-2b for ano-genital warts

Lubiprostone phase 3 clinical trial in Japan for chronic idiopathic constipation meets primary endpoint

Aerovance reports top-line results from Aerovant Phase 2b clinical trial for eosinophilic asthma

Phase 2 study results of Qnexa in patients with OSA presented at SLEEP 2010

Columbia completes enrollment in PROCHIEVE 8% Phase III study to reduce preterm birth in short cervix women

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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