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ARQ 197 demonstrates 66% improvement in median PFS in patients with advanced NSCLC

ArQule, Inc. today announced that ARQ 197, when used in combination with erlotinib, demonstrated a 66% improvement in median Progression-Free Survival in patients with advanced, refractory non-small cell lung cancer.

31 Mar 2010

PhRMA report: 234 medicines in development for special health care needs of children

America's pharmaceutical research and biotechnology companies are developing 234 medicines for the special health care needs of children, according to a new report released today by the Pharmaceutical Research and Manufacturers of America.

31 Mar 2010

PolyMedix completes Phase 1B clinical study with PMX-30063 defensin-mimetic antibiotic

PolyMedix, Inc., an emerging bio-technology company focused on developing new therapeutic drugs to treat acute cardiovascular disorders and infectious diseases, has successfully completed a Phase 1B clinical study with its novel defensin-mimetic antibiotic, PMX-30063. The data from the study demonstrate that administration of multiple doses of PMX-30063 are safe and well-tolerated at dose levels which showed bactericidal activity in blood samples drawn from subjects in the study.

31 Mar 2010

NMS Labs launches test to evaluate the efficacy of Milnacipran

NMS Labs launches another unique test suitable for the evaluation of toxicity vs. efficacy, the potential for physicians to establish therapeutic drug monitoring of individual patients, and the assessment of drug diversion of a new pain management drug therapy.

31 Mar 2010

Patients switching to Victoza experience further reductions in A1c and weight loss

Diabetes Care published online the results of the Novo Nordisk LEAD™ 6 extension study, which evaluated the efficacy and safety of switching from exenatide, which is taken twice a day, to once-daily Victoza®. Results show that when added to oral antidiabetes drugs, patients who switched from exenatide to Victoza experienced further reductions in A1c and weight loss.

31 Mar 2010

Study indicates estrogenic drug could help treat schizophrenia

An estrogenic drug that influences neurotransmitter and neuronal systems in the brain is showing promise as an effective therapy for women who suffer from schizophrenia.

31 Mar 2010

Study evaluates OCP treatment to prevent endometrioma recurrence

Ovarian endometriomas, better known as ovarian 'chocolate' cysts for the brown liquid they contain, can be easily removed by surgery. However, recurrence is common, which can cause ongoing pain and complications. A study evaluated for Faculty of 1000 suggests a simple and effective remedy - the oral contraceptive pill.

31 Mar 2010

YM BioSciences receives approval to expand enrolment in Phase I/II clinical trial of CYT387

YM BioSciences Inc., announced that it has received ethics board approval to expand enrolment in its Phase I/II clinical trial of CYT387 at Mayo Clinic in patients with myelofibrosis, a chronic debilitating condition, where patient's bone marrow is replaced by scar tissue.

31 Mar 2010

Titan Pharmaceuticals commences Phase 3 study of Probuphine for opioid addiction

Titan Pharmaceuticals, Inc. today announced the initiation of a randomized, placebo and active controlled, multi-center Phase 3 clinical study of Probuphine in the treatment of opioid addiction. This confirmatory Phase 3 study will be conducted at approximately 23 sites in the United States and randomize approximately 250 patients into three arms: Probuphine (100 patients), Suboxone® (100 patients) and placebo (50 patients).

31 Mar 2010

NovaBay Pharmaceuticals reports net income of $2.7M for 2009 against year-ago loss

NovaBay Pharmaceuticals, Inc., a clinical stage specialty pharmaceutical company developing first-in-class, anti-infective compounds for the treatment and prevention of antibiotic-resistant infections, today reported full-year and fourth quarter financial results for 2009. The company also highlighted recent progress of its proprietary and partnered development programs.

30 Mar 2010

Two Phase I studies of Stedivaze demonstrate safety in patients with asthma and COPD

Clinical Data, Inc., today announced results from two Phase I studies of Stedivaze™ (apadenoson), which demonstrated that Stedivaze was safe and well tolerated in patients with asthma and chronic obstructive pulmonary disease (COPD). Stedivaze is a potent and highly selective agonist of the adenosine A2A receptor subtype in development as a pharmacologic stress agent for myocardial perfusion imaging (MPI).

30 Mar 2010

Study suggests two distinct versions of multiple sclerosis

There may be two distinct versions of multiple sclerosis, a study in both animal models and human blood samples suggests. What's more, a patient's responsiveness to the most popular first-line drug for this episodic and all-too-often recurring autoimmune condition seems to depend on which version that patient has.

30 Mar 2010

Fecal incontinence: Sacral nerve stimulation along with Medtronic InterStim Therapy promising

Data published in the March issue of the Annals of Surgery show that investigational use of sacral nerve stimulation with Medtronic InterStim® Therapy reduces fecal incontinent episodes and increases quality of life in patients with the condition. The 120-patient, multi-center study - the largest trial of its kind in the world and the first such trial in North America - examined the efficacy of InterStim Therapy in patients with chronic fecal incontinence who had failed or were not candidates for more conservative treatments.

30 Mar 2010

Britain popping “pills for every ill”, says research

A new study reports that Britons are turning to prescription drugs for every illness, minor or major. This recent paper titled “A Pill for Every Ill”, published in Social Science & Medicine journal says that while two decades earlier average number of prescriptions dispensed per person was only eight, it is more than 16 now.

30 Mar 2010

Systemic treatment of microRNA therapeutic targeting miR-10b inhibits breast cancer metastasis

Regulus Therapeutics Inc. today announced the publication of new results in the journal Nature Biotechnology by Regulus scientists and collaborators. The new study demonstrated that systemic treatment of a microRNA therapeutic targeting microRNA-10b in tumor-bearing mice inhibits breast cancer metastasis. Cancer-related metastasis is a major cause of mortality and current cancer treatments have limited utility suppressing the metastatic spread of cancer cells. microRNA therapeutics targeting miR-10b represent a promising approach for the discovery and development of a novel anti-metastatic agent.

30 Mar 2010

GSK re-submits sNDA for Avodart to FDA

GlaxoSmithKline announced today that it has re-submitted the supplemental New Drug Application for Avodart® (dutasteride) for prostate cancer risk reduction among men at increased risk of developing the disease to the US Food and Drug Administration.

30 Mar 2010

Intellikine, Tragara Pharmaceuticals awarded $1M each for developing new multiple myeloma therapies

The Multiple Myeloma Research Foundation (MMRF) today announced that two San Diego area biotech firms, Intellikine and Tragara Pharmaceuticals, Inc. will receive funding via its MMRF Biotech Investment Award program. The MMRF Biotech Investment Awards represent a multi-year research grant commitment to fund the early-stage drug development of novel compounds and approaches that show potential in treating multiple myeloma. Based on the companies' achievement of clearly defined milestones, the MMRF will commit a total of $1,000,000 to each company by the end of 2011.

30 Mar 2010

Enobia Pharma unveils findings from first HPP self-reported patient survey at ACMG 2010

Enobia Pharma Inc. unveiled findings from the first hypophosphatasia self-reported patient survey intended to evaluate the burden of illness associated with HPP at the 2010 American College of Medical Genetics Annual Clinical Genetics Meeting.

30 Mar 2010

Cephalon receives FDA Complete Response Letter for NUVIGIL supplemental new drug application

Cephalon, Inc. today announced the company has received a Complete Response letter from the U.S. Food and Drug Administration (FDA) for its supplemental new drug application for NUVIGIL® (armodafinil) Tablets [C-IV] in the treatment of patients with excessive sleepiness associated with jet lag disorder resulting from eastbound travel.

30 Mar 2010

NexMed files IND with FDA for Phase II trial of PrevOnco for HCC

NexMed, Inc, a specialty CRO with a pipeline of products based on the NexACT® technology, today announced that the Company has filed an Investigational New Drug (IND) application with the U.S. Food & Drug Administration (FDA) for a Phase II trial of its recently acquired cancer drug candidate PrevOnco™, in combination with doxorubicin in patients with advanced, unresectable hepatocellular carcinoma (HCC). The FDA has 30 days to comment on the IND before NexMed can proceed with human testing.

29 Mar 2010

Efficacy News and Research

ARQ 197 demonstrates 66% improvement in median PFS in patients with advanced NSCLC

PhRMA report: 234 medicines in development for special health care needs of children

PolyMedix completes Phase 1B clinical study with PMX-30063 defensin-mimetic antibiotic

NMS Labs launches test to evaluate the efficacy of Milnacipran

Patients switching to Victoza experience further reductions in A1c and weight loss

Study indicates estrogenic drug could help treat schizophrenia

Study evaluates OCP treatment to prevent endometrioma recurrence

YM BioSciences receives approval to expand enrolment in Phase I/II clinical trial of CYT387

Titan Pharmaceuticals commences Phase 3 study of Probuphine for opioid addiction

NovaBay Pharmaceuticals reports net income of $2.7M for 2009 against year-ago loss

Two Phase I studies of Stedivaze demonstrate safety in patients with asthma and COPD

Study suggests two distinct versions of multiple sclerosis

Fecal incontinence: Sacral nerve stimulation along with Medtronic InterStim Therapy promising

Britain popping “pills for every ill”, says research

Systemic treatment of microRNA therapeutic targeting miR-10b inhibits breast cancer metastasis

GSK re-submits sNDA for Avodart to FDA

Intellikine, Tragara Pharmaceuticals awarded $1M each for developing new multiple myeloma therapies

Enobia Pharma unveils findings from first HPP self-reported patient survey at ACMG 2010

Cephalon receives FDA Complete Response Letter for NUVIGIL supplemental new drug application

NexMed files IND with FDA for Phase II trial of PrevOnco for HCC

Industry Focus eBook - Cell & Gene Therapy (1st Edition) eBook

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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