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. 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.
Walking through the halls of CPhI Worldwide, it was hard to recognise it as the space just a few short hours before; the place had been transformed by teams, presumably working through the night, and the addition of a good many people provided enough hustle and bustle even early on to indicate that it would be a good show for all. 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 »
It’s a well-known fact that new product approvals in the pharma industry have been in decline in recent years. In 2010, for instance, the FDA only approved 21 new drugs compared with 26 and 24 in 2009 and 2008, respectively. July 2011, however, saw the FDA approve its twenty-first product for 2011 with AstraZeneca’s blood-thinner Brilinta, so it seems as if the agency is set to outpace 2010’s dreary approval numbers. Read more »
From PharmTech.com