The end of 2009 is creeping closer and analysts are already looking towards 2010 and wondering what new challenges are in store for the pharma industry. After the turbulent year of 2009, some may be relieved to know that analyst firm Ovum, part of the Datamonitor Group, believes that dramatic changes are unlikely. Read more »

The US Senate’s vote this past weekend to proceed with debate on a legislative proposal for healthcare reform portends—what by all accounts—promises to be yet another rigorous round of policy and political opinion. A Google search for the past week alone shows that almost 500,000 blogs (459,049 at the time of posting of this blog) have been posted in response to the Senate’s action to move forward with considering healthcare reform. In the swirl of this public opinion, where does the pharmaceutical industry stand? Read more »

The international pharmaceutical supply-chain consortium Rx-360 held a launch meeting in Europe last week with more than 135 industry and regulatory representatives in attendance. Read more »

Technology is not the answer, at least not for tackling pharmaceutical counterfeiting. Instead, increasing criminal sanctions and encouraging relevant parties to work with “certified and reliable partners” are the real solutions. Read more »

GlaxoSmithKline (GSK) Biologics and Nabi Pharmaceuticals announced this week that the companies are partnering to develop an investigational vaccine for treating nicotine addition and preventing smoking relapse. The announcement is an interesting example of a novel application for a vaccine. Read more »

Friday the 13th was an unlucky day for Genzyme (Cambridge, MA). On that day, the company and the US Food and Drug Administration alerted healthcare providers that stainless steel fragments, nonlatex rubber, and fiberlike material had been found in products filled at Genzyme’s Allston Landing manufacturing facility. The enzyme-replacement products Cerezyme, Fabrazyme, Myozyme, Aldurazyme, and Thyrogen were affected. FDA advised that visual inspection and filtration of the products should reduce the risk of administering contaminated medicines to patients. Read more »

A new study published in the American Journal of Public Health claims that prescription drug direct-to-consumer advertising (DTCA) can be harmful to a person’s health. According to the researchers, prescription drug advertisements are “not doing a good job of helping consumers to make better decisions about their health”. Read more »

The proliferation of online health information and media vehicles such as blogs and social-networking sites create a new problem for the consumer—how to judge the reliability of such information. To address that problem, the US Food and Drug Administration is holding hearings this week, Nov. 12–13, in Washington DC, regarding the promotion of FDA-regulated medical products using the Internet and social-media tools. The hearings, which will include participation from pharmaceutical trade associations, drug companies, consumer groups, and media representatives, is the first step in a public dialogue that FDA is having as it evaluates how the statutory provisions, regulations, and policies concerning advertising and promotional labeling should be applied to product-related information on the Internet and newer media technologies. Read more »

After much ado, the US House of Representatives passed a healthcare-reform bill this weekend. Drugmakers and commentators are understandably eager to parse the bill to find out what it would mean for the pharmaceutical and biopharmaceutical industries. So what’s the verdict? Read more »

The US Agency for International Development (USAID) and the US Pharmacopeial Convention (USP) recently announced a new program designed to fight the growing problem of substandard and counterfeit drugs in developing countries. Read more »