The Polymer Processing Institute (PPI), an independent, not-for-profit, research and development organization that is headquartered at the New Jersey Institute of Technology (NJIT), has expanded its mission of working with industry and government to advance the field of polymer processing to include generating and using fundamental knowledge related to incorporating APIs into polymer excipients through hot-melt extrusion. I recently visited with the PPI researchers and toured their facilities. Read more »
The recent presidential and vice-presidential debates have highlighted the need for strategies for economic growth in the US, including the roles innovation and trade play in stimulating the US economy. Eli Lilly Chairman, President and CEO John C. Lechleiter recently weighed in on the issue with respect to the pharmaceutical industry in offering his perspective on the importance of including data exclusivity provisions for biologics as found in US law for the Trans-Pacific Partnership (TPP), a regional free trade pact in Asia under negotiation.
The CPhI Innovation Awards, this year rebranded as the CPhI Pharma Awards, took place last week at CPhI Worldwide in Madrid, and put into prominence some key scientific advances of exhibitors at CPhI. The awards were designed to encourage entries in diverse areas, including formulation development, drug delivery, chemical manufacturing of APIs and intermediates, and biomanufacturing. Read more »
Recent years of low approvals of new blockbuster products have given rise to the perception that pharmaceutical drug development, in its current format, no longer works. Recent late-stage failures of clinical trials have also served to emphasise the risky nature of drug development. So what’s the alternative?
At the end of last week, GlaxoSmithKline placed its bets on open innovation as a new way forward for developing medicines. Read more »
Innovation is the cornerstone of the pharmaceutical industry. That innovation is not only seen in new drug development but also in approaches to extend the lifecycle of a given product through improved formulations and drug-delivery systems. Recent advances and trends in drug-delivery systems were highlighted at one of the sessions at the Pre-Connect Conference held at CPhI Worldwide in Madrid this week.
The value of innovation was emphasized by Catalent, who provided insight on the increasing role of drug-delivery systems in solving complex drug-development challenges, such as bioavailability problems, and improving patient outcomes. The company shared research showing that compared with conventional formulations, advanced drug-delivery systems can potentially increase the value of existing drugs by 25–50% through patent-life extension, product differentiation, accelerated product development and market entry, better patient outcomes and compliance, and improved returns on R&D investment. Read more »
Tufts University research shows that silk protein can be used to stabilize and maintain the potency of vaccines and other drugs that would otherwise need refrigeration. “Silk stabilization has the potential to significantly change the way we store and deliver pharmaceuticals, especially in the developing world,” said research-paper author and Tufts doctoral student, Jeney Zhang, in a press release. Read more »
PhRMA Senior Vice-President Matthew Bennett released a statement today on the state of the biopharmaceutical industry, in response to an analysis in the British Medical Journal. Bennett states that while the US may be lagging behind in spurring innovation programs, he believes the passage of the Prescription Drug User Fee Act (PDUFA) will improve the situation.
Much negative criticism has been directed at the pharmaceutical industry’s perceived lack of innovation in recent years, but one area that has received a lot of attention is neglected diseases. One of the latest developments that I’ve read about is an EU-funded project led by GlaxoSmithKline to develop new treatments for multiple drug resistant tuberculosis (TB). Read more »
The end of the year is just around the corner so I thought I’d spend some time today looking at how marketing authorisation applications are progressing at the European Medicines Agency. The past few years have witnessed some dreary numbers in both Europe and the US when it comes to new products, but the figures for 2011 could be early indicators for a 2012 upturn. 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.