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Pfenex, Hospira sign agreement to develop and commercialize LUCENTIS biosimilar

Pfenex Inc., a clinical-stage biotechnology company engaged in the development of biosimilar therapeutics, and Hospira, Inc., the world's leading provider of injectable drugs and infusion technologies, and a global leader in biosimilars, today announced that the companies have entered into an agreement to exclusively develop and commercialize for worldwide sales PF582, Pfenex's biosimilar candidate to Genentech's LUCENTIS (ranibizumab injection).

10 Feb 2015

eClinicalHealth announces approval of Europe's first remote clinical study in patients with diabetes

eClinicalHealth Limited, a technology and consulting company dedicated to providing innovative clinical trial solutions, is proud to announce the Ethical Committee approval of VERKKO in Finland - Europe's first remote clinical study to include full electronic informed consent.

10 Feb 2015

Synthetic Biologics reports positive results from SYN-004 Phase 1b trial to prevent C. difficile infection

Synthetic Biologics, Inc., a developer of pathogen-specific therapies for serious infections and diseases, with a focus on protecting the microbiome, today announced positive topline safety and tolerability results from a Phase 1b clinical trial of SYN-004, the Company's investigational oral beta-lactamase enzyme designed to protect the microbiome and prevent Clostridium difficile (C. difficile) infection, antibiotic-associated diarrhea and secondary antibiotic-resistant infections in patients receiving intravenous (IV) beta-lactam antibiotic therapy.

10 Feb 2015

Study findings help improve lung cancer screening guidelines

A set of guidelines developed to help standardized lung cancer screening would have generated considerably fewer false-positives than the National Lung Screening Trial produced, according to a new retrospective study.

10 Feb 2015

Excluding cancer survivors from lung cancer clinical trials may not be justified, study finds

The common practice of excluding patients with a prior cancer diagnosis from lung cancer clinical trials may not be justified, according to a study by researchers from UT Southwestern Medical Center.

10 Feb 2015

Regulus Therapeutics reports top-line results from RG-101 clinical study for HCV treatment

Regulus Therapeutics Inc., a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, today announced top-line results from the 4 mg/kg cohort and additional results from the 2 mg/kg cohort in a completed clinical study evaluating RG-101, a wholly-owned, GalNac-conjugated anti-miR targeting microRNA-122 ("miR-122"), for the treatment of hepatitis C virus infection ("HCV").

9 Feb 2015

Use of STAN in addition to usual monitoring does not improve perinatal outcomes

In a study to be presented on Feb. 5 in an oral plenary session at 8 a.m. PST, at the Society for Maternal-Fetal Medicine's annual meeting, The Pregnancy Meeting™, in San Diego, researchers will report that use of the ST segment (STAN) as an adjunct to conventional intrapartum electronic fetal heart rate monitoring did not improve perinatal outcomes or decrease operative deliveries in hospitals in the United States.

9 Feb 2015

Investigators develop microbiome map of New York City subway system

The microbes that call the New York City subway system home are mostly harmless, but include samples of disease-causing bacteria that are resistant to drugs -- and even DNA fragments associated with anthrax and Bubonic plague -- according to a citywide microbiome map published today by Weill Cornell Medical College investigators.

9 Feb 2015

Abiraterone drug improves survival in prostate cancer patients when given before chemotherapy

Pioneering prostate cancer drug abiraterone significantly extends the lives of men with advanced prostate cancer if given before chemotherapy, the results of a major phase III clinical trial have shown.

9 Feb 2015

Salicylates drugs reduce proliferation, viability of cultured vestibular schwannoma cells

Researchers from Massachusetts Eye and Ear and the Harvard Medical School/ Massachusetts Institute of Technology's Program in Speech and Hearing Bioscience and Technology have demonstrated that salicylates, a class of non-steroidal inflammatory drugs (NSAIDs), reduced the proliferation and viability of cultured vestibular schwannoma cells that cause a sometimes lethal intracranial tumor that typically causes hearing loss and tinnitus.

9 Feb 2015

Researchers pinpoint key moments at which intervening decreases risk of death in hypertension patients

High blood pressure is the most common risk factor for heart disease and death worldwide, and yet the answers to some of the most basic questions about how to manage it - when to introduce new medications, intensify treatment or re-evaluate a patient - remain unclear. In a new study published this week in the British Medical Journal, researchers from Brigham and Women's Hospital examined the outcomes of 88,000 adults with hypertension to pinpoint the precise high-blood-pressure level and critical time points at which intervening was tied to a decrease in the risk of death.

9 Feb 2015

UM SOM launches ‘Program in Lung Healing’ to develop treatments for acute respiratory failure

University of Maryland School of Medicine (UM SOM) Dean E. Albert Reece, MD, PhD, MBA, and Jeffrey A. Rivest, MS, President and Chief Executive Officer of University of Maryland Medical Center (UMMC), today announced the official launch of a new "Program in Lung Healing," that will further the School's position as a national leader in research, education and clinical innovation for acute ailments of the lung and respiratory system.

9 Feb 2015

Helsinn begins elsiglutide Phase IIB trial for prevention of chemotherapy-induced diarrhea

Helsinn Healthcare S.A. and Zealand Pharma A/S jointly announce that Helsinn has started a Phase IIB clinical dose-finding trial of elsiglutide for the prevention of chemotherapy-induced diarrhea (CID). The first patients out of a planned total of 600 patients with colorectal cancer treated with chemotherapy have been dosed in the trial.

8 Feb 2015

Marken launches new marketing campaign to solidify its place as industry's only Clinical Logistics Organization

Marken is starting its 35th year as a specialist logistics company and has launched a new marketing campaign to solidify its place as the industry's only Clinical Logistics Organization (CLO).

6 Feb 2015

Prostate cancer patients with detectable post-operative PSA should receive more aggressive treatment

Prostate cancer patients with detectable prostate specific antigen (PSA) following radical prostatectomy should receive earlier, more aggressive radiation therapy treatment, according to a study published in the February 1, 2015 issue of the International Journal of Radiation Oncology * Biology * Physics (Red Journal), the official scientific journal of the American Society for Radiation Oncology.

6 Feb 2015

G1 Therapeutics receives $33 million in Series B funding to develop effective treatments for cancer

An RTP-based pharmaceutical company with roots at the University of North Carolina at Chapel Hill has received $33 million in Series B venture capital funding to develop more effective and less toxic methods to treat patients with cancer.

6 Feb 2015

ECOG-ACRIN Cancer Research Group opens clinical trial for women with newly diagnosed DCIS

In direct response to recommendations made by a National Institutes of Health scientific consensus panel, the ECOG-ACRIN Cancer Research Group announced today the opening of E4112, a clinical trial for women with newly diagnosed ductal carcinoma in situ (DCIS) of the breast who, together with their doctors, will use the results of a magnetic resonance imaging (MRI) exam to determine whether to undergo a lumpectomy or a mastectomy.

6 Feb 2015

TrialReach raises $13.5M in Series B financing round

TrialReach, the world's largest provider of clinical trial information, today announced it has raised a $13.5M Series B financing round led by Smedvig Capital with participation from existing investors Amadeus Capital Partners and Octopus Investments. With one of the biggest digital health rounds ever raised in the United Kingdom, TrialReach plans to use the funds to support the growth of its clinical trial platform and expansion into the U.S..

6 Feb 2015

RXi closes exclusive global license agreement with Hapten Pharmaceuticals for Samcyprone

RXi Pharmaceuticals Corporation, a biotechnology company focused on discovering and developing innovative therapies addressing high-unmet medical needs, today announced the closing of its previously disclosed exclusive global license agreement for the therapeutic use of Samcyprone with Hapten Pharmaceuticals, LLC.

5 Feb 2015

Retigabine drug could reduce debilitating impact of strokes

New research suggests that an already-approved drug could dramatically reduce the debilitating impact of strokes, which affect nearly a million Americans every year.

5 Feb 2015

Clinical Trial News and Research

Pfenex, Hospira sign agreement to develop and commercialize LUCENTIS biosimilar

eClinicalHealth announces approval of Europe's first remote clinical study in patients with diabetes

Synthetic Biologics reports positive results from SYN-004 Phase 1b trial to prevent C. difficile infection

Study findings help improve lung cancer screening guidelines

Excluding cancer survivors from lung cancer clinical trials may not be justified, study finds

Regulus Therapeutics reports top-line results from RG-101 clinical study for HCV treatment

Use of STAN in addition to usual monitoring does not improve perinatal outcomes

Investigators develop microbiome map of New York City subway system

Abiraterone drug improves survival in prostate cancer patients when given before chemotherapy

Salicylates drugs reduce proliferation, viability of cultured vestibular schwannoma cells

Researchers pinpoint key moments at which intervening decreases risk of death in hypertension patients

UM SOM launches ‘Program in Lung Healing’ to develop treatments for acute respiratory failure

Helsinn begins elsiglutide Phase IIB trial for prevention of chemotherapy-induced diarrhea

Marken launches new marketing campaign to solidify its place as industry's only Clinical Logistics Organization

Prostate cancer patients with detectable post-operative PSA should receive more aggressive treatment

G1 Therapeutics receives $33 million in Series B funding to develop effective treatments for cancer

ECOG-ACRIN Cancer Research Group opens clinical trial for women with newly diagnosed DCIS

TrialReach raises $13.5M in Series B financing round

RXi closes exclusive global license agreement with Hapten Pharmaceuticals for Samcyprone

Retigabine drug could reduce debilitating impact of strokes

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