Geron announced earlier this week that it was discontinuing its clinical trial evaluating the use of embryonic stem cells for the treatment of spinal cord injury. The company said it planned to discontinue its embryonic stem cell research program, and focus instead on its oncology pipeline. The reason given was economic. According to the company press release, “The decision to narrow Geron’s technology and therapeutic focus was made after a strategic review of the costs, value inflection timelines and clinical, manufacturing and regulatory complexities associated with the Company’s research and clinical-stage assets.” In other words, the company did not expect to recover enough revenue soon enough from the therapy to justify the expense of the remaining trials and the expense of continuing development. Read more »

The US Supreme Court, as expected, will decide if key provisions of the Obama administration’s health care overhaul law violate the Constitution by exceeding the federal government’s power to regulate interstate commerce and to levy taxes. The key issue is whether Congress can require every American to purchase health insurance by 2014 or pay a penalty. State officials and other parties are challenging the constitutionality of the individual mandate provision in the Affordable Care Act (ACA), and differing legal rulings on the issue has brought it to the High Court for a final ruling. Read more »

FDA approved 35 innovative drugs in fiscal 2011, including treatments for hepatitis C, prostate cancer, Hodgkin’s lymphoma, and lupus. This number of approvals is among the highest in the past 10 years, and it reflects the agency’s efforts to hasten patients’ access to new drugs. In the past two years, the agency’s lower levels of approvals—21 drugs in 2010 and 25 in 2009—caused concern throughout the industry and in Congress. We may feel grateful to FDA, but we also should ask how the agency achieved this high number of approvals.

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It’s getting harder for the pharmaceutical industry to ignore neglected diseases. The globalization of national economies and the rise in air travel are increasing the potential for exposure to these diseases, which previously had been limited to the developing world. “Now is the time to have this discussion,” Kishor M. Wasan, chair-elect of the American Association of Pharmaceutical Scientists’s Pharmaceuticals in Global Health Focus Group, told Pharmaceutical Technology earlier this month. Industry now seems to be getting the message. Read more »

As the unemployment rate hovers around 9.1%, the federal government needs to find ways to create jobs. Congress is debating whether a tax break on repatriated money would prompt companies to hire more workers, as I mentioned last week. Meanwhile, the Obama administration is eyeing another potential means of stimulating job growth: investing in biological research. Read more »

Worried about our persistently high rate of unemployment (and his bid for re-election), President Obama is urging Congress to pass portions of his jobs bill. In addition to aiding the economy, creating jobs could help reduce the number of people who are forgoing medications, which would be a boon for the pharmaceutical industry. Perhaps with this in mind, the Association of Clinical Research Organizations (ACRO) has thrown its weight behind a bill it says would create American jobs.

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Drug shortages are an acute problem that keeps getting worse. Last year, about 211 drugs were in short supply, which was a new record. This year, the number of new drug shortages already has reached 213, according to the University of Utah Drug Information Service. As a result, many patients now have limited access to crucial drugs, such as cancer therapies and medicines for potentially lethal infections. And a Congressional committee is now investigating what appears to be an insult added to this injury. Read more »

Immunology was the focus of the 2011 Nobel Prize for Physiology or Medicine with the October 3 announcement that the award will be shared by three whose work has been seminal in the understanding of immune system function.  Half the award will go to Drs. Jules A. Hoffmann and Bruce A. Beutler for their discoveries concerning the activation of innate immunity, and the other half will go to the estate of Dr. Ralph M. Steinman for his discovery of the dendritic cell and its role in adaptive immunity. Read more »

A few weeks ago, Representative Michele Bachmann (R-MN) made waves by claiming that the vaccine for human papillomavirus could have dangerous side effects. She retreated from her remarks after the American Academy of Pediatrics said that they had no scientific validity. Makers of biopharmaceuticals might feel vindicated, but a recent poll emphasizes that Bachmann is not alone in her views. Read more »

The senate appropriations bill released on September 20, 2011 contained a modest $190 million cut in funding for the National Institutes of Health (NIH), but also contained language creating the National Center for Advancing Translational Research (NCATS), a branch of the NIH devoted to translating basic science into treatment and cures for diseases. The purpose of the new center is not to develop new therapeutics, but to develop innovative tools and methods for drug development that will accelerate the development of medical products. In this way, NCATS will complement, and not compete with, the work of the private sector and other NIH translational science efforts. Read more »