Just read Mina Kime's enlightening account of the J&J McNeil quality disaster in Fortune. Forget about the fact that the adulterated products did not and most likely would not have harmed consumers, the problems cited are very serious and go straight to the heart of GMP's. 

I spoke yesterday with Rutgers' Fernando Muzzio, just to catch up on what's happening with the C-SOPS (Center for Structured Organic Particulate Systems) project that his institution, as well as Purdue, NJIT, and PR Mayaguez, are heading up. C-SOPS continues to expand in partners, grants, and technologies that it hopes to license, Muzzio said, and we'll share more on this in the next month or two on PharmaManufacturing.com.

Conventional wisdom in the industry suggests that drug product recalls are on the rise, and in fact if you look at the chart that leads off this CNN Money report today, you'd say the 2009 escalation is quite alarming. On closer inspection, as the article points out, many of these recall events are due to the problems of a few manufacturers, such as Advantage Dose.

According to the World Health Organization, we are now in the post-pandemic phase of H1N1. Good riddance. While the virus remains, the threat of another widespread outbreak has passed, says WHO Director-General Margaret Chan.

Last week, I posted this item on current research taking place regarding the impact that drug compounds in our water supplies might have upon us, and upon the broader ecology. It's an issue we continue to monitor and will continue to write about.

Some of the news reports that followed FDA's recent approval of the blood-thinner Lovenox suggested that it was the Agency's first approval of a biosimilar, or follow-on biologic. (Here's one example.) In a recent interview with Ed Silverman of Pharmalot, Jonathan Pan of Scientia Advisors disputes that Lovenox is a true biosimilar (as vague as that definition may be). Says Pan, "Lovenox is not a biologic like a protein or antibody.

Last week, FDA announced that it had joined EPA and other federal agencies in Tox21, a program to improve, and greatly accelerate, chemical screening of toxicologically active chemicals. The program had been in place for two years, but FDA’s participation signals a new scope and new possibilities.

Last year, we blogged about reports of unusually high levels of APIs in the water supplies in and around Patancheru, a hotbed of drug manufacturing in India. (Here are several posts, including interviews with The Land Institute’s expert Stan Cox.)

A few weeks ago, we hosted a webcast which addressed questions surrounding the relatively slow uptake of single-use technologies for biopharma measurement and control. Speakers Michael Kowolenko (formerly Sr. VP with Wyeth Biotech and Biogen Idec), Kit Erlebach (Merck) and Paul Priebe (Sartorius Stedim) offered a range of perspectives on what has been holding back single-use in biopharma. (A partial transcript is below.

While there is increasing acceptance of the idea of cannabis-based drugs and the use of marijuana for medicinal purposes (particularly in California), there is still political resistance across much of the U.S. Britain's GW Pharma continues to push ahead with Sativex, which was approved in Canada five years ago for neuropathic pain associated with MS. MHRA has now also approved its use related to spasticity in MS patients (see press release in italics below).