Last week, I complained about the British weather (which is still awful by the way) and outlined how the pharma industry is already preparing for this year’s winter flu season. Following on from that, I’ve just read a really interesting story about the holy grail of flu vaccine manufacturers — the possibility of a super, universal vaccine that could protect against all common strains of influenza. Read more »

Embryonic stem cell research has been fraught with legal uncertainties since its inception. Embryonic stem cells are pluripotent cells obtained from embryonic tissue in a process that usually results in the destruction of the embryo. Once an embryonic stem cell line is established, however, it can be expanded and used by multiple labs for multiple research projects. Read more »

Transparency and communication have been popular catch phrases for FDA of late. In addition to launching a transparency initiative and a blog to increase interaction with industry and the public, the agency released this week a report that makes communication one of seven priorities for the Center for Drug Evaluation and Research (CDER). The report, Identifying CDER’s Science and Research Needs, discusses internal research initiatives and goals for contributing to the agency’s overall regulatory science efforts. In doing so, it identifies seven areas of regulatory science that are in need of improvement, and one focuses specifically on evaluating “the effectiveness and impact of different types of regulatory communications to the public and other stakeholders.” Read more »

As the White House and Congress battle the looming deadline to raise the country’s debt ceiling, what are the potential implications of the various debt-reduction proposals on the pharmaceutical industry? Read more »

It’s crunch time on Capitol Hill. Before Congress will consider raising the debt ceiling by next week’s deadline, they have insisted on achieving a budget deal that will reduce the federal debt over the long term. Tensions have mounted as President Obama and leading lawmakers have taken turns grandstanding and negotiating. Both parties agree that spending cuts should be part of the budget deal, and some Democrats have expressed willingness to find opportunities for savings in Medicare and Medicaid. But these programs might now be spending less money if one bill on the Senate’s calendar had passed when it was originally introduced. Read more »

Most of you are probably enjoying the summer weather. Unfortunately, I’m based in the UK where June and July have been saturated with wet windy days. To add to the wintery feeling, this week I’ve read a lot in the news about flu vaccines. Just as some of us in the north of England have already accepted that summer is over (before it began I might add), vaccine manufacturers are also preparing for this winter’s round of seasonal influenza. Read more »

As recently as a few years ago, patients infected with HIV living in Africa were likely to be turned away from health clinics, with no help for treatment in sight. They were told to go home and plan their funerals. This was the story old on NPR news radio this week. But a few recent studies may presage a different ending to this sad story. Read more »

Some drugmakers have blamed what they see as a slow and overly cautious FDA for the industry’s weak pipelines. Last week, I cited drug-approval figures to show that the agency was not standing in the way of innovation. A closer look at the figures contradicts another part of the critics’ argument—the industry’s pipelines may not be so weak after all. Read more »

Health Technology Assessment (HTA) processes are supposed to improve access to innovative treatments and medicines. But are they doing their job? Perhaps not: a new report examining HTAs has highlighted several areas for improvement. In particular, the report found little evidence that current HTA processes accelerate access to medicines or result in better rewards for medicines with high therapeutic values. Read more »

Overseas manufacturing has brought benefits in terms of lowering the cost of producing APIs and excipients used in US drug products, and of many finished drugs sold the US. The dark side of the arrangement, and the one that worries consumers, manufacturers, and regulatory agencies, is that quality control becomes very difficult when supply chains involve the routing of thousands of products through manufacturers, packagers, and distributers dispersed around the world. The worst-case scenario, where adulterated ingredients end up in finished drug products was realized in late 2007, when adulterated heparin sourced from China caused adverse drug reactions and the deaths of some patients. Read more »