The Biotechnology Industry Organization (BIO) has won the latest battle over follow-on biologics. Last week, the House Energy and Commerce Committee approved Rep. Anna Eshoo’s (D-CA) amendment to the America’s Affordable Health Choices Act (H.R. 3200). The Eshoo amendment, a regulatory pathway for the approval of biosimilars, would grant about 12 years of market exclusivity to each new biological medicine. Read more »

Congress has taken up the Obama administration’s goal of making healthcare more affordable by introducing various strategies for reducing the cost of prescription drugs. But the Pharmaceutical Research and Manufacturers of America and the Biotechnology Industry Organization (BIO) have resisted several of Congress’s initiatives, and cost control has been elusive so far. Read more »

President Obama’s plan for lowering the cost of healthcare relies partly on ensuring that affordable generic drugs are available to patients. This strategy is not likely to be palatable to innovator companies, who have tried various ways of delaying generic drugs’ introduction to the market. Read more »

So far, the first quarter of 2009 has been full of initiatives that call for, if not push for, change in the pharmaceutical industry and in medical science overall. Some may say it started when Obama took office. Within six weeks of leading the country, he announced $1.1 billion for comparative effectiveness research. Then, his proposed FY 2010 budget included support for a regulatory pathway for follow-on biologics. And this week, he reversed the ban on the use of federal funding for stem-cell research.

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The wait may soon be over for US Food and Drug Administration employees wondering who their new boss will be. President Obama is expected to introduce Governor Kathleen Sebelius of Kansas today as his new nominee for secretary of the US Department of Health and Human Services. Read more »

No doubt millions were moved by President Barack Obama’s inauguration speech yesterday. Having listened to and read it several times, it occurred to me that many of his messages apply directly to our industry. Read more »

Pharmaceutical Technology focuses much of its attention on the companies that manufacture the world’s drugs. We’ve noticed many stories on the wires lately that describe how the current economic situation is hurting drugmakers. But several press releases I saw today reminded me that patients are experiencing difficult times, too. Read more »

As the pieces of President-Elect Barack Obama’s administration fall into place, one looming choice of great importance to the pharmaceutical and biotechnology industries is the choice of the next commissioner of the US Food and Drug Administration. A recent article in the Wall Street Journal (WSJ) put forth speculation on possible candidates for the top post. Read more »

President-elect Barack Obama is moving quickly in selecting former Senate majority leader Tom Daschle as the potential secretary of Health and Human Services. Daschle has been a close advisor to Obama and may now be the administration’s point person on moving health reform legislation through Congress. Reform advocates consider the selection a sign that the Obama administration will seek to fulfill its promises to make health reform a top priority. Read more »