PharmExec Blog

Tufts Figures on Drug Development Spark Debate

By Agnes Shanley, Pharmaceutical Technology.

The Tufts University Center for the Study of Drug Development (CSDD) released its latest research on the costs and timeframes required for launching a new drug.

Although the study acknowledges that it still takes about 10 years to launch a new brand-name pharmaceutical, this year, the costs required were estimated at $2.6 billion (in 2013 dollars), $1.4 billion of that for out-of-pocket costs and another $1.2 billion in time costs (i.e., the cost of missed opportunities, when resources are channeled from other potential activities to the development of a specific drug). In 2003, CSDD put the figure at $802 million (in 2000 dollars, which would be $1044 in 2013 dollars), so the latest figures reflect an increase of 145%, or a compound annual growth rate of 8.5%. Read More »

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Shire to Relocate More Than 500 Jobs to Lexington, MA

Shire plans to relocate more than 500 positions to Massachusetts from its Chesterbrook, PA, site and establish Lexington, MA, as the company’s US operational headquarters. The transition is a continuation of the company’s “One Shire” efficiency program and will streamline business globally through two principal locations—Massachusetts and Switzerland—with support from a limited number of regional and country-based offices around the world. Read More »

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Breakthrough Therapy Program Exceeds FDA’s Expectations

The two-year-old initiative to accelerate the development and approval of highly effective drugs and biologics has enabled a number of important new medicines to reach patients sooner,  according to Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER). Twelve breakthrough drugs have been approved over the past two years, for several critical conditions as well as cancer, and dozens more are in the pipeline. The response to the breakthrough program by sponsors has “exceeded expectations,” Woodcock observed last week at a conference sponsored by the Friends of Cancer Research and the Bookings Institution. And this is “good news for patients,” she added. Read More »

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GSK and Novo Nordisk Lead on Access Index

Last week, the Access to Medicine Foundation released its 2014 Index rating the performance of companies in broadening access to medicines in low and middle-income countries.

For the fourth time, GSK leads the index with Novo Nordisk taking second. J&J. Novartis, Gilead and Merck KGaA rank three to six with nearly even scores.

Read More »

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CytRx Faces Partial Clinical Hold after Death in Compassionate Use Program

CytRx announced on Tuesday that FDA gave notice of a partial clinical hold for trials for its oncology candidate aldoxorubicin.

The hold results from a reported death of a late-stage cancer patient “who did not qualify to participate in any of the ongoing aldoxorubicin clinical trials, but had received aldoxorubicin under the Company’s expanded access (“compassionate use”) program”, states the release. Read More »

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