Clinical Intelligence

Oncolytics Biotech completes patient enrollment in phase II ovarian cancer study

Friday, September 5, 2014 09:53 AM

Oncolytics Biotech has completed patient enrollment in a randomized, phase II study of paclitaxel plus reolysin versus paclitaxel alone in patients with persistent or recurrent ovarian, fallopian tube or primary peritoneal cancer (GOG186H).

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Quest Diagnostics

Debiopharm Group's antibiotic Debio 1450 receives QIDP designation from the FDA

Friday, September 5, 2014 09:40 AM

Debiopharm Group, a Swiss-based global biopharmaceutical company developing prescription drugs that target unmet medical needs including anti-infective and oncology therapeutics as well as companion diagnostics, has announced that the FDA has designated its anti-infectious agent Debio 1450 as a Qualified Infectious Disease Product (QIDP) for the treatment of acute bacterial skin and skin structure infections (ABSSSI).

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The CenterWatch Monthly, September 2014

Tuesday, September 2, 2014 07:00 AM
Today’s fastest, most economical sponsors

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Scientists looking across human, fly and worm genomes find shared biology

Thursday, August 28, 2014 02:47 PM

Researchers analyzing human, fly, and worm genomes have found that these species have a number of key genomic processes in common, reflecting their shared ancestry.  The findings, appearing in the journal Nature, offer insights into embryonic development, gene regulation and other biological processes vital to understanding human biology and disease. 

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Amgen submits BLA for evolocumab to the FDA

Thursday, August 28, 2014 02:14 PM

Amgen has submitted a Biologics License Application (BLA) to the FDA for evolocumab seeking approval for the treatment of high cholesterol. Evolocumab is an investigational, fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove low-density lipoprotein cholesterol (LDL-C), or "bad" cholesterol, from the blood.

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Pfizer, Merck to collaborate on anti-cancer combination regimen

Wednesday, August 27, 2014 10:01 AM

Pfizer and Merck have entered into an agreement to explore the therapeutic potential of the combination of Pfizer’s crizotinib (XALKORI) with Merck’s investigational anti-PD-1 antibody pembrolizumab, in a phase Ib clinical study evaluating the safety and tolerability of the combination in patients with ALK-positive advanced or metastatic non-small cell lung cancer (NSCLC).  The financial terms of the agreement have not been disclosed. 

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FDA advisory committee recommends approval of Tiotropium Respimat COPD

Thursday, August 21, 2014 10:31 AM

The FDA Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted (10 yes, three no) that existing data supports approval of Boehringer Ingelheim's investigational tiotropium bromide inhalation spray for long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema and to reduce exacerbations in COPD patients. If approved by the FDA, the proposed proprietary name for tiotropium bromide inhalation spray will be Spiriva Respimat.

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Positive results released for Amgen’s phase III study of AMG 416

Thursday, August 21, 2014 10:24 AM

Amgen has announced that a second placebo-controlled, phase III study evaluating AMG 416 for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD), receiving hemodialysis, met its primary and all secondary endpoints.

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FDA approves Biogen Idec’s Plegridy for multiple sclerosis

Monday, August 18, 2014 09:13 AM

The FDA has approved Biogen Idec’s Plegridy (peginterferon beta-1a), a new treatment for people with relapsing forms of multiple sclerosis (RMS). Plegridy, the only pegylated beta interferon approved for use in RMS, is dosed once every two weeks and can be administered subcutaneously with the Plegridy Pen, a new, ready-to-use autoinjector, or a prefilled syringe.

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FDA approves Avastin to treat aggressive and late-stage cervical cancer

Friday, August 15, 2014 12:43 PM

The FDA has approved a new use for Avastin (bevacizumab) to treat patients with persistent, recurrent or late-stage (metastatic) cervical cancer.

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CWWeekly

May 26

inVentiv Health aims to help sponsors prepare for new E.U. regulations on observational studies

ACRP partners with CRO Analytics to measure investigative sites' views of clinical trial quality

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The CenterWatch Monthly

May

Job satisfaction mixed as workload increases
Salaries not keeping pace with rise in work, responsibilities

Gamification moving from early science to patient use
Pharma looking to use games for early diagnosis, recruitment, adherence

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The CenterWatch Monthly

April

PSI, INC Research, Chiltern best with sites
Strategic outsourcing prioritizing, improving site relationships

Regulatory compliance an increasing burden on sites
Increased staff time, materials, storage eroding site operating profit

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