The Pharma ChemOutsourcing conference, an annual event that brings together pharmaceutical companies, CROs, and CMOs to discuss industry trends and perspectives, was held in Long Branch, New Jersey, last week. The central question at the heart of many of the discussions was a fundamental but important one: where is the opportunity in pharmaceutical outsourcing, specifically in pharmaceutical chemical development and manufacturing? Read more »

As I wrote last week, the market for vaccines is expanding, and the newswires have stories about these products almost daily. Sanofi and GlaxoSmithKline, to name just two major players, are increasing investments in research and manufacturing capacity for these therapies. Kalorama Information predicts that sales of pediatric vaccines will grow even more quickly than sales for adult vaccines. Yet drugmakers have surely noticed that not all publicity about vaccines has been positive. Read more »

The recent volatility in financial markets, combined with reports of stagnant US economic growth, point to less-than-optimistic prospects for a recovery. The underlying weakness in the US economy reveals structural flaws, which are not likely to be amerliorated in the short term, one of which is a lack of private-sector investment in domestic manufacturing. Are there lessons that can be learned from emerging markets in fostering growth in domestic manufacturing? Read more »

Even more than visiting the exhibit floor, I enjoy attending the presentations at INTERPHEX, which will take place next week in New York. The sessions always reflect the current hot topics within the pharmaceutical industry, and this year is no exception. Observers have been predicting that vaccines will be the industry’s new growth area, so my eye was drawn to the various biopharmaceutical talks listed on the INTERPHEX schedule of events. Read more »

Beginning in September 2009, I watched with increasing surprise as Johnson & Johnson (J&J) recalled more and more of its products. As the recalls kept coming, my surprise turned to amazement that some of the company’s facilities (particularly the one at Fort Washington, Pennsylvania) could have been maintained and run in such an apparently haphazard way. As time went on, my amazement ebbed, and the continuing stream of recalls elicited little more than a shrug. Read more »

Earlier this week I took a trip to Liverpool (UK) to the Downstream Processing Day hosted by SAFC and Sartorius Stedim Biotech. A lot of interesting topics were discussed, including vaccine manufacture, which is a particularly hot issue both inside and outside of the industry at the moment. Read more »

There was no joy in Paris, at least at sanofi-aventis (Paris) headquarters, on Friday. When the company’s offer to acquire Genzyme (Cambridge, MA) at $69 per share expired that day, fewer than 1% of the biopharmaceutical company’s outstanding shares had been tendered. In response, sanofi extended its deadline to January 21, 2011 without modifying the terms of its offer. Why should the company expect a different result in six weeks’ time? Read more »

Journalists continue to comb through the latest batch of diplomatic cables released by WikiLeaks, seeking to interpret the mass of raw information. Until now, the cables’ significance has seemed to be limited to political circles. But one cable turns out to contain the 2008 version of the Critical Foreign Dependencies Initiative (CFDI) list, which names international facilities that could be considered crucial for American security. Perhaps not surprisingly, the list cites several pharmaceutical and biopharmaceutical facilities. Read more »

In January 2011, control of the US House of Representatives will shift to the Republican party. Reducing the federal deficit is one of the party’s top priorities, and Republican leaders have proposed to cut domestic spending as a means to accomplish this end. But should all programs be put on the chopping block? Read more »

Does federal law shield the makers of vaccines from product-liability lawsuits? Last week, the US Supreme Court began considering this question, which is the heart of a lawsuit against Wyeth, now a part of Pfizer (New York). Read more »