DIA Biosimilars 2013

Ranbaxy Laboratories

Gilead collaborates with Indian partners to reduce costs, improve availability of antiretroviral therapy

Thursday, August 2, 2012 02:44 PM

Pharmaceutical companies Gilead Sciences, Mylan Laboratories, Ranbaxy Laboratories and Strides Arcolab have entered into agreements to collaborate on promoting access to high-quality, low-cost generic versions of Gilead's HIV medicine emtricitabine (FTC) in developing countries, including single tablet regimens containing emtricitabine and fixed-dose combinations of emtricitabine co-formulated with other Gilead HIV medicines.

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Cenduit: Now with Patient Reminders

Furiex's phase II PPD-10558 trial does not meet primary efficacy endpoint

Friday, December 9, 2011 12:49 PM

Furiex Pharmaceuticals has reported top-line results from the phase II trial of the investigational drug PPD-10558 in patients with statin-associated myalgia, or SAM. PPD-10558 did not meet its primary efficacy endpoint in this randomized, double-blind, proof-of-concept study. The study enrolled patients with high cholesterol and a prior history of SAM, and evaluated recurrence rates for SAM over a twelve-week treatment period across the following three different treatment regimens: placebo; PPD-10558; and atorvastatin (Lipitor). Patients did not report any significant differences in muscle symptoms, nor did they drop out due to SAM in significantly different percentages, among the three regimens. As expected, however, PPD-10558, a novel statin, did significantly lower LDL-cholesterol compared with placebo, and the compound also had a favorable safety profile.

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CRF Health – eCOA Forum

FDA approves first generic version of Lipitor

Thursday, December 1, 2011 12:17 PM

The FDA has approved the first generic version of the cholesterol-lowering drug Lipitor.

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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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