DIA Biosimilars 2013

Clinical Intelligence

Lightlake Therapeutics touts positive phase II results of binge eating disorder

Thursday, August 9, 2012 11:23 AM

Lightlake Therapeutics, an early stage biopharmaceutical company developing modern addiction treatments, released final data from a phase II study of its proprietary opioid antagonist naloxone nasal spray treatment for patients with binge eating disorder (BED).

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Cenduit: Now with Patient Reminders

FDA approves Zaltrap for metastatic colorectal cancer

Monday, August 6, 2012 12:51 PM

The FDA has approved Sanofi-Aventis’ Zaltrap (ziv-aflibercept) for use in combination with a FOLFIRI (folinic acid, fluorouracil and irinotecan) chemotherapy regimen to treat adults with colorectal cancer.

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CRF Health – eCOA Forum

Aquapharm Biodiscovery discovers novel antibiotic compound

Monday, August 6, 2012 11:01 AM

Aquapharm Biodiscovery, a Scottish marine biotechnology company, has made a discovery in the development of next-generation antibiotics.

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Array BioPharma’s ARRY-797 meets primary endpoint in osteoarthritis study

Friday, August 3, 2012 12:41 PM

Boulder, Colo.-based Array BioPharma’s phase II study of ARRY-797 met its primary endpoint osteoarthritis patients suffering from moderate to severe knee pain despite the use of non-steroidal anti-inflammatory drugs (NSAIDs).

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Pfizer releases top-line data from phase III study of tofacitinib in RA

Friday, August 3, 2012 11:24 AM

Pfizer reported today top-line results from ORAL Start (A3921069), a phase III study of the investigational agent tofacitinib, a novel, oral Janus kinase (JAK) inhibitor for the treatment of adults with moderate-to-severe active rheumatoid arthritis (RA).

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Auxilium touts top-line data from Xiaflex study in Dupuytren's contracture

Monday, July 30, 2012 11:34 AM

Auxilium Pharmaceuticals, a specialty biopharmaceutical company based in Malvern, Penn., issued positive top-line data from its phase IIIb trial evaluating Xiaflex for the treatment of adult Dupuytren's contracture patients with multiple palpable cords. 

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FDA approves Vascepa for severe hypertriglyceridemia

Friday, July 27, 2012 10:53 AM

The FDA has approved Vascepa (icosapent ethyl) capsules as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe hypertriglyceridemia (TG ≥ 500mg/dL), according to Amarin, a Bedminster, N.J.-based biopharmaceutical company focused on cardiovascular health.

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Fast-acting TB drug cocktail shows great promise

Friday, July 27, 2012 10:48 AM

Phase II results from a novel anti-tuberculosis drug cocktail—PA-824, moxifloxacin and pyrazinamide—show the elimination of 99% of the Mycobacterium tuberculosis, the causative agent of tuberculosis (TB), found in patients’ saliva following just two weeks of treatment.

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FDA OKs Rayos for rheumatoid arthiris and more

Friday, July 27, 2012 10:31 AM

The FDA has approved Horizon Pharma’s Rayos (prednisone) delayed-release tablets (1mg, 2mg and 5 mg) to treat a broad range of diseases including rheumatoid arthritis (RA), polymyalgia rheumatica (PMR), psoriatic arthritis (PsA), ankylosing spondylitis (AS), asthma and chronic obstructive pulmonary disease (COPD). 

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Vaccine created from patient white blood cells to target brain tumors

Friday, July 27, 2012 08:13 AM

Researchers at Northwestern Brain Tumor Institute (NBTI) are seeking to understand if a vaccine made from a patient's own blood cells may slow the growth of glioblastoma multiformes (GBM), the most common and aggressive type of primary brain tumor.

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September 30

Novartis-Walgreens pilot study blurring the line between retail pharmacy, investigative site

CISCRP to launch traveling science museum exhibit to demystify clinical trial participation

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The CenterWatch Monthly

October

New growth and decline in Asia clinical trials
South Korea, Japan, China see big growth in 1572s, while India posts huge drop

Harnessing Big Data to transform clinical trials
From protocol to patient recruiting, data analytics can yield valuable insights

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September

Sponsors look to collaborate on comparator drugs
Co-therapies, comparators are in 60% of studies, cost $25m per company a year

Early adopters implement risk-based monitoring pilot programs
Experiments aim to offer long-term solutions, despite short-term uncertainties

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