Category Archives: R&D

After Delays, Project DataSphere Rolls Out

An industry and academic data-sharing project went live on Tuesday, nearly a year after the platform was expected to launch. Visitors to the site – no credentials needed – can register and access de-identified clinical data from the comparator arms of nine oncology trials, with more to come. Project DataSphere, the newest data transparency and […]
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Pricing and Reimbursement in Europe: Where Does Innovation Fit?

By Leela Barham. It was recently said, in reference to the UK’s Value-Based Assessment(VBA) program, that innovation had not been “tried and tested in the pricing context”, which explains the loss of the “innovation” criteria from the proposals formerly known as Value-Based Pricing (VBP). This prompted me to think about just how has innovation been […]
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Clinical Trials in the Digital Age

In 1995, there were 16 million internet users — or 0.4% of the world’s population. In just 17 years, this figure has grown to 2.4 billion and 34.3% adoption. At the current rate, each year, the penetration percentage sees a 2–4% growth. Many services, such as banking, have moved towards online service models, shutting down branch […]
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FDA Wants YOU!

A number of top management positions at the Center for Drug Evaluation and Research (CDER) need to be filled, and Center leaders are looking for experienced industry managers to help rebuild its staff. Many experienced FDAers are ending their careers or taking on new challenges, creating a need for “renewal and replenishment” of the agency, […]
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The Sovaldi Case: Is American Biotech History About to Repeat Itself?

Recent Congressional investigations over the pricing scheme of Gilead’s much-heralded hepatitis C drug Sovaldi – and a decline in stocks across the biotech sector – rings a familiar bell, writes Tom Norton. Twenty years ago in May, US Senator Joe Lieberman carefully questioned biotech CEO Harry Penner of then Neurogen Corporation about why his company’s […]
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