We all depend on the US Food and Drug Administration to enforce standards that keep our drugs safe. We expect the agency to set clear guidelines for consumers and manufacturers to follow. We also assume that the agency has standards for its own activities and ways of ensuring that agents comply with those standards. Unfortunately, a recent report from the US Government Accountability Office (GAO) shows that FDA has not entirely lived up to our expectations. Read more »

These days, mandatory furloughs and staff cuts have employees in all industries nervously glancing over their shoulders. The pharmaceutical industry is no exception. Last week, Merck (Whitehouse Station, NJ) revealed plans to reduce its workforce by 15% by the end of 2012. Read more »

These days, research scientists, much like Rodney Dangerfield, can’t get any respect. The latest evidence of this arrived on Friday, when AstraZeneca (London) proposed to cut 3500 research and development (R&D) jobs by 2014. 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 »

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 »

It’s a new year and the cusp of a new decade. In boardrooms and management suites, pharmaceutical and biopharmaceutical executives are asking each other how their companies can develop innovative new products and turn a profit in the coming years. Here’s my unsolicited advice: hire more women managers. Read more »

We take for granted that drinking tap water is not going to alter our mood and that eating salmon is not going to throw our hormones out of balance. But trace amounts of pharmaceuticals have been found in drinking water and aquatic life, raising questions about how these chemicals could affect human health. Local and federal governments began to address the issue this year, and a new project by the Environmental Protection Agency (EPA) could be the basis for future solutions. Read more »

Art imitates life, and sometimes drug-delivery mechanisms do, too. Scientists often draw inspiration from natural agents and the body’s processes when developing carriers for therapies. Synthetic red blood cells are a new product of this strategy that seems to raise new possibilities in drug delivery. Read more »

Despite, or because of, economic difficulties and meager pipelines, the recent past has seen many drug companies investigate alternative delivery methods for new and established products. A new deal between GlaxoSmithKline (GSK, London) and Intercell (Vienna) reflects this trend and raises hopes for the development of innovative routes of administration. Read more »

Last week, Genzyme’s (Cambridge, MA) Allston Landing, Massachusetts, plant resumed production of Cerezyme, the company’s treatment for Gaucher’s disease. Genzyme presumably found and eliminated the source of contamination that had been reported weeks earlier. You’d think that after putting out this latest fire at the troubled plant, the company would be justified in heaving a sigh of relief. Read more »