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, 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 »

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 pharmaceutical and biopharmaceutical industries have jealously guarded their intellectual property for years. Companies routinely use patents to prevent competitors from making generic versions of their drugs. When pipelines have weakened, companies have developed new formulations or delivery methods to extend patent protection for their established drugs. The economic crisis has only sharpened this reflex.

That’s why news from Ecuador made me do a doubletake. Read more »

The pace of progress in stem-cell research seems to be quickening, and the field’s future looks promising. Last week, a team at the Harvard Stem Cell Institute found what looks like a revolutionary way to create stem cells that could be safe enough to use as treatments in humans. Read more »

When pipelines run dry, pharmaceutical companies are more likely to investigate alternative delivery methods as a way of distinguishing their drugs in the marketplace. In the past few weeks, I’ve noticed several intriguing delivery methods created by researchers around the world. I recently wrote about the new technique of encapsulating medicines in magnetite nanoparticles for repeated, long-term delivery. Along similar lines, scientists at Queen Mary, University of London have created “micro shuttles” that can be loaded with drugs and opened remotely. Read more »

Last week, I wrote that the increased attention to biological drugs, which are mostly taken through injections, was spurring interest in needle-free and implantable delivery methods for vaccines. Research into alternative delivery methods for vaccines could produce innovative ways of delivering other kinds of drugs as well, and I recently read about an inspired idea that a team of Boston researchers had for delivering intermittent doses of drugs. Read more »

Have you ever considered getting a flu shot but quailed at the sight of the needle? Lots of people hate getting injections, but this delivery method is still the predominant technique for administering biological drugs. Rising demand for vaccines and other biologicals is one factor spurring manufacturers to seek alternative delivery methods that could one day rescue the needlephobic. Read more »

Two announcements made on two consecutive days last week vividly showed that whether a thing is helpful or harmful often depends on how we use it. The announcements’ subject? Tobacco. Read more »

Last Thursday, the Biotechnology Industry Organization (BIO) weighed in on a patent issue that will soon be before the Supreme Court. In an amicus brief, BIO argued that the Court should overturn Bilski v. Doll, a decision of the US Court of Appeals for the Federal Circuit. The case involved Bernard L. Bilski’s method for hedging risks in commodities trading. Read more »