DIA Biosimilars 2013

GlaxoSmithKline

AltheRx acquires Solabegron from GSK

Tuesday, March 29, 2011 12:39 PM

AltheRx, a privately-held clinical development company, has purchased all assets related to Solabegron from GlaxoSmithKline. Solabegron is a highly selective and potent beta3-adrenoceptor agonist that has demonstrated positive results in phase II clinical programs for the treatment of overactive bladder (OAB) in women and irritable bowel syndrome (IBS). Solabegron also demonstrated a favorable tolerability profile across all phase II studies.

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Cenduit: Now with Patient Reminders

Neuroscience drug development slows, requires funding

Tuesday, March 29, 2011 11:49 AM

Many European pharmaceutical companies have significantly reduced their workflow in the realm of neuroscience, according to Fierce Biotech. Companies are challenged with a high risk of trial failure while investors demand new products. 

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CRF Health – eCOA Forum

Impax Labs' Parkinson's drug aces late-stage clinical trial

Friday, March 18, 2011 01:41 PM

Hayward, Calif.-based Impax Laboratories said the Parkinson's drug it in-licensed from GlaxoSmithKline last year—its second attempt at an extended-release version of caribidopa-levadopa—beat out the standard of care for controlling a key symptom of the disease in a late-stage study, according to FiercePharma.

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Tolerx and GSK report on phase III DEFEND-1 study for diabetes

Thursday, March 17, 2011 01:35 PM

Tolerx and GlaxoSmithKline (GSK) said the phase III DEFEND-1 study of otelixizumab, an investigational humanized anti-CD3 monoclonal antibody, did not meet the primary efficacy endpoint of change in C-peptide at month 12 in patients with new-onset autoimmune type 1 diabetes. 

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Pfizer talking with CROs to fill R&D hub

Wednesday, March 16, 2011 12:33 PM

A U.K. task force—assembled to salvage as many R&D jobs at Sandwich as it can before Pfizer completes its planned exit—has confirmed that the pharma giant is in discussions with CROs that may step in to hire some of the 2,400 workers being let go, according to Fierce Biotech.

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Report: Big Pharmas embracing technology as they transform to ‘holistic healthcare entities’

Monday, March 14, 2011 07:00 AM

Pharmaceutical companies—having outsourced R&D functions to CROs and collaborated with biotechs, drug companies and academic groups for innovative products and platforms—are now embracing a different type of innovation: technology.

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Epizyme collaborates with Eisai

Thursday, March 10, 2011 01:45 PM

Just weeks after GlaxoSmithKline committed up to $650 million in its epigenetics pact with Cambridge, Mass.-based Epizyme, Japan's Eisai has joined the promising discovery platform with a $206 million collaboration of its own, according to Fierce Biotech.

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GSK, Targacept end agreement

Friday, March 4, 2011 02:28 PM

GlaxoSmithKline has terminated a pact with Targacept that was exploring treatments for a variety of conditions, including smoking cessation, obesity and Parkinson’s disease, according to PharmaTimes.

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FDA approves Promacta

Tuesday, March 1, 2011 01:10 PM

GlaxoSmithKline said the FDA has granted full approval for Promacta (eltrombopag), an oral tablet that can raise platelet counts in patients with the rare blood disorder chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.

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Competition aims to recognize, reward skilled U.S. clinical researchers and raise industry profile

Monday, January 24, 2011 12:06 PM

Clinical research associates, study nurses, trial managers and clinical research teams have a chance to win $1,000 prizes in a competition designed to measure their technical and interpersonal skills in a changing global industry and raise the profile of clinical research in the United States.

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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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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
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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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