Afinitor boasts considerable commercial potential

The FDA has approved Novartis's Afinitor for advanced renal cell carcinoma patients who have progressed after first-line Sutent or Nexavar treatment. Not only is this Afinitor's first approval in the oncology market, the commercial potential in this indication is considerable as there are currently no approved second-line therapy options.

High unmet needs remain for TB in the developing world

Despite being a global disease, the burden of tuberculosis is most severe in developing countries, particularly Asia and Africa. In these regions, case detection rates are low, which poses a significant obstacle for its control. Although the key unmet need in the developing world is a novel vaccine targeting the pulmonary instance of the disease, new antibiotics may hold significant potential.

Telehealth holds great potential but wider awareness may not lead to adoption

Datamonitor believes that telehealth has reached the tipping point in terms of awareness, with IBM following Intel's entrance into the market, prominent media coverage and a rise in the number of conferences highlighting the technology. However, despite the benefits that telehealth offers to both providers and patients, the question remains as to whether this awareness will lead to adoption.

HemCon Medical Technologies, Inc. Announces Improved, Results from Live Nail Infection Study 

PORTLAND, Ore. – March 25, 2009 – HemCon today announced results from an independent study investigating the time required to successfully treat fungal infected human nails which is a leading cause of Onychomycosis, the most common type of fungal nail infection.

Biosimilars: time for an approval pathway in the US

Congress has received another bill seeking to establish a biosimilars approval pathway in the US.

HR 1427 represents the latest attempt to secure legislation for a biosimilars approval pathway in the US. With a five year exclusivity period, the proposed bill will be viewed as pro-biosimilar and could therefore face considerable opposition from prescription drug manufacturers. However, given the escalating cost of healthcare in the US, the industry is under pressure to find a solution.

Merck and Schering-Plough mega-merger to create a company greater than the sum of its parts

As a standalone company, Merck & Co. faces a tough future of declining sales. Datamonitor forecasts that the merger with Schering-Plough will succeed in returning Merck to positive sales growth and provide a raft of new pipeline and marketed products. However, before this can be achieved, outstanding issues surrounding Schering-Plough's partnership with Johnson & Johnson must be resolved.

Biosimilars in the EU: delivering the goods?

In January, leading pharmaceutical experts attended the 2009 Forum Institute seminar on biosimilars, and the challenges involved in their successful development and launch. While the main focus of the meeting the biosimilars market in the EU, it was widely agreed that developments in the US, and President Obama's handling of the generic biotech issue, will be the defining issue of 2009 and beyond.

by Dr. Paul Stoffels, the company group chairman of pharmaceutical research and development at Johnson & Johnson

Collaborative innovation for the post-crisis world

LAST WEEK, world and business leaders converged at Davos to wrestle with the global economic crisis and discuss solutions for "Shaping the Post-Crisis World" in six areas, including economics, politics, innovation, science, technology, and new business models. As a physician, a pharmaceutical research and development business leader, and a global citizen, I see one major road to economic recovery and that is through innovation.