The economic recession—recovering or not—was bound to affect FDA at some point. In his 2010 State of the Union address, President Obama proposed a spending freeze for US government agencies and programs that are not tied to national security. Entitlement programs such as Social Security and Medicare also would not be affected. “Like any cash-strapped family, we will work within a budget to invest in what we need and sacrifice what we don’t,” said the President in his speech. Read more »

Hands up those of you who read the labels on your medication bottles ‘every’ time you’re due to administer a dose? Not many of you I bet. While much publicity highlights the dangers of counterfeit drugs (and rightly so), what about the dangers linked to incorrectly taking genuine medication? Read more »

Only a day after the results of two Phase III clinical trials involving Novartis’s oral therapy for multiple sclerosis (MS) were published in The New England Journal of Medicine (NEJM), the media has leapt on the positive trial data and hailed the therapy as “hope for MS patients” that can “dramatically reduce relapse”. That’s great news, but hold on… the therapy hasn’t even been approved yet! Read more »

Haiti is the only nation in the Latin American and Caribbean region still considered a least developed country (LDC) by the United Nations. After this month’s earthquake devastated the nation of 9.7 million, it has been heartwarming to see hundreds of disaster relief crews and humanitarian organizations respond to the crisis. Pharmaceutical companies have been part of the picture as well—delivering millions of dollars in funds and medicines, either directly to Haiti or through nonprofit organizations. GlaxoSmithKline (GSK) is among the many pharmaceutical manufacturers, including Pfizer, Abbott Laboratories, Amgen, Merck, Eli Lilly, contributing aid to Haiti. Read more »

The numbers are in, and it looks like 2009 produced a bumper crop of biopharmaceuticals. The US Food and Drug Administration approved a record 16 new biopharmaceutical entities last year, as opposed to 10 in 2008, according to a study by the Biotechnology Information Institute. Seven recombinant-protein or antibody products were approved last year, continuing an upward trend for these molecules. Great news, right? Read more »

The European Commission has said it will be taking a close look at patent settlements where an originator has paid off a generic competitor in return for delayed market entry of a generic drug. Only yesterday, the EC released a statement saying that it has asked certain pharmaceutical companies to submit copies of their patent settlement agreements completed between originator and generic companies between July 2008 and Dec. 31, 2009. Read more »

Scientific innovation and technology are at the core of long-term economic health, so how do the United States and other developed nations compare with each other and with the fast-growing economies in Russia, China, India, and Brazil? And what has been the impact of the current financial crisis on investment in innovation? Read more »

The US Food and Drug Administration has unveiled the first phase of its Transparency Initiative: a new website called FDA Basics provides the public with detailed information on what the agency does, who works there, and how regulated products are approved for the marketplace. Read more »

Last week we saw more signs that pharmaceutical megamegers bode ill for New Jersey workers. Business Week reported that Pfizer (New York) planned to close six research and development (R&D) facilities—some of its own, and some of Wyeth’s (Madison, NJ). Many of the 400 employees at Wyeth’s research offices in Monmouth Junction, New Jersey, could be laid off. And last Wednesday, Richard Clark, CEO of Merck (Whitehouse Station, NJ), told attendees at a Goldman Sachs conference that research jobs at Schering-Plough’s (Kenilworth, NJ) headquarters could be eliminated to reduce costs. Read more »

Now that award season is here, it seems fitting that the pharma industry has announced the production of a new film. Wait, did I just write that? Yes, as did a slew of other surprised bloggers this week. Pharma is going Hollywood. Read more »