The start of a new year, particularly a new decade, brings a sense of resolve that helps to bring a clarity of purpose. Looking back at 2009, we have chronicled much change in the pharmaceutical and biotechnology industries—the megamergers, the impact of the financial crisis on the emerging pharma sector, slowing pharmaceutical industry growth, the rise of emerging markets, and the resulting changes on the supplier base. All important concerns, but in the spirit of the beginning of a new year and decade, I would like to take a moment to look at the heart of the matter for the pharmaceutical industry—the promise of new drug development. Read more »

This week the California Institute for Regenerative Medicine (CIRM), which is the California state body responsible for stem-cell research funding, and two international partners in Canada and the United Kingdom, announced awards totaling $230 million to 14 research teams in California, Canada, and the UK to develop stem-cell-based therapies for 11 diseases. The funding, in the form of four-year grants, marks the first CIRM funding that is explicitly expected to result in filings with the US Food and Drug Administration for initial human clinical testing of therapies based on stem-cell research, according to a CIRM press release. Read more »

I’ve been paying attention to Merck’s (Whitehouse Station, NJ) Gardasil vaccine ever since I first heard of it because it’s a subject that combines biopharmaceuticals, gender issues, and the politics of public health. At first, critics contended that giving young girls Merck’s human papillomavirus (HPV) vaccine would not just prevent cervical cancer, but also promote promiscuity. This concern may have subsided, but two new wrinkles in the Gardasil story came to light on Friday. 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 »

Prostate cancer remains one of the most common cancers and the second-leading cause of cancer death in American men, according to the American Cancer Society. So far, treatments for prostate cancer include drugs that affect the entire body, instead of only cancer cells. Work by a team of researchers at Purdue University offers hope they have found a new method of not only finding and targeting these cancer cells, but also carry therapeutic drugs directly to the site of infection. Read more »

Reading the wires every day reinforces my impression that biological drugs are an evolving field that may soon become a major segment of the pharmaceutical industry. But a new report from Research and Markets reminded me that a form of gene therapy also promises interesting discoveries and potential cures. Read more »

It has long been predicted that breakthroughs in genomics will foster an entirely new generation of pharmaceutical and biopharmaceutical therapies. Now, five and a half years after the Human Genome Project published the full sequence human genome, the first population-wide study to gather human genetic data is set to begin. Read more »

I’m not an astrologist, but sometimes you have to wonder whether plans were hatched under a bad sign. It certainly seems that way for “Vytorin,” a cholesterol-lowering drug that combines simvastatin and “Zetia.” The drug, introduced by Merck and Schering-Plough, has suffered damaging revelations. Read more »

Seven months after Pfizer (New York) pulled “Exubera” from the market, the star-crossed product’s saga continues. Pfizer apparently plans to close its Terre Haute, Indiana, manufacturing facility, which had gotten a cash infusion to prepare it to produce—you guessed it—Exubera. The company insists that the plant closure is unrelated to Exubera’s failure, but I find that hard to believe.

Is this plant closure the final nail in the coffin of inhaled insulin?

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People always giggle when I say that, but it’s true. Of all the “basic” sciences, biology is the most slippery. By that I mean that, while the tendency is to study biomolecules and cells in isolation, the total animal, be it a bacterium or a human being, is a federation of molecules, organelles, or organs (depending on how big and multicellular you are), and they all act together to create a phenotype, a behavior, a syndrome, or a disease in the intact organism.
So it should hardly be a surprise to anyone who recognizes this fact that drugs for complex conditions, developed with reductionist biological models, yield disappointing results in the clinic. And yet it is. Read more »