DIA Biosimilars 2013

Clinical Intelligence

Actelion's macitentan meets primary endpoint in phase III PAH study

Monday, April 30, 2012 12:10 PM

Switzerland-based Actelion Pharmaceuticals' initial analysis indicates that the pivotal, long-term phase III SERAPHIN study with macitentan, a novel dual endothelin receptor antagonist, has met its primary endpoint.

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Cenduit: Now with Patient Reminders

Pharmanest initiates phase I SHACT trial

Monday, April 30, 2012 11:45 AM

Pharmanest, a Stockholm-based pharmaceutical company, has dosed its first patient has in an open label pharmacokinetic phase I study with its drug candidate SHACT, a product developed for pain relief in connection with intrauterine device (IUD) insertion.

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CRF Health – eCOA Forum

Oral BG-12 garners positive phase III results in MS

Wednesday, April 25, 2012 12:15 PM

In a second phase III trial (CONFIRM), Biogen Idec’s oral BG-12 (dimethyl fumarate) demonstrated efficacy across a variety of clinical and radiological outcome measures, as well as favorable safety and tolerability profiles in patients with relapsing-remitting multiple sclerosis (RRMS).

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Europe approves Signifor, first drug for Cushing's disease

Wednesday, April 25, 2012 11:20 AM

The European Commission has approved Novartis’ Signifor (pasireotide) for the treatment of adult patients with Cushing's disease for whom surgery is not an option or for whom surgery has failed. Signifor is the first medicine to be approved in the E.U. targeting Cushing's disease.

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Abbott touts positive results in phase III Parkinson's trial

Wednesday, April 18, 2012 03:39 PM

Abbott has released results from a phase III trial evaluating the company's investigational compound, levodopa-carbidopa intestinal gel (LCIG), for advanced Parkinson's disease.

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Drug reduced number of MS lesions in phase II trial

Wednesday, April 18, 2012 12:37 PM

An investigational oral drug called ONO-4641 reduced the number of lesions in people with multiple sclerosis (MS), according to the results of a phase II clinical trial supported by Ono Pharmaceutical.

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ImmunoGen initiates phase I trial in non-Hodgkin's lymphoma

Wednesday, April 18, 2012 12:14 PM

ImmunoGen, a biotechnology company that develops anticancer therapeutics using Targeted Antibody Payload (TAP) technology, has begun a phase I trial of its IMGN529 anticancer compound.

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Access Pharma reports positive interim results in MuGard phase IV trial

Wednesday, April 18, 2012 11:37 AM

Access Pharmaceuticals, a biopharmaceutical company focused on oncology, has released interim results from its ongoing MuGard phase IV clinical trial in oral mucositis.

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UCB touts positive phase III Cimzia results

Monday, April 16, 2012 03:58 PM

UCB reported positive top-line results from a phase III study designed to evaluate the efficacy and safety of Cimzia (certolizumab pegol) in patients with adult-onset active axial spondyloarthritis (AxSpA), a family of inflammatory rheumatic diseases which includes ankylosing spondylitis (AS).

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FDA clears Cerecor’s FP01

Wednesday, April 11, 2012 04:04 PM

Baltimore-based biopharmaceutical company Cerecor’s Investigational New Drug (IND) application for FP01 for the treatment of cough has cleared the 30 day deliberation period by the FDA. 

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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
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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