The pharmaceutical industry has sometimes been slow to embrace ideas that promise great practical benefits. The industry’s ingrained aversion to risk is partly to blame, but it’s usually not the whole story. Take the quality-by-design (QbD) initiative, which posits that the better a company understands a product’s quality attributes, the more likely that product will be safe and efficacious. The industry has generally supported this initiative, and Pfizer has brought it into the spotlight. Read more »

Botox is a household name when it comes to vanity and related calls for cosmetic surgery. Produced by bacteria (Clostridium botulinum), botulinum is a powerful neurotoxin—it seems strange to me that people have overcome such dangerous sounding words to repeatedly request that it be injected in their face. But then again, fans of tattoos and piercings are not phased by thick needles, pain (or disfigurement), and (off-topic but interesting) a British student recently had her tongue surgically lengthened to help improve her Korean pronunciation. We’re ok with body modification then. And why not? Read more »

The Office of the Inspector General (OIG), with no fuss, fanfare, or explanation, has halted efforts to exclude Forest Laboratories CEO Howard Solomon from doing business with federal healthcare programs. In a letter to Forest Laboratories, the OIG simply states: “Based on a review of the information in our file and consideration of the information that your attorneys provided to us, both in writing and during an in-person meeting, we have decided to close this case. We anticipate no further action related to this matter.” Read more »

Giving goes a long way, and lately, industry and regulators seem to be more open to giving out information. FDA and EMA recently released an update about their joint pilot programs. One pilot, which ran December 2008 to December 2010 and involved FDA, EMA, the European Directorate for the Quality of Medicines, and the Australian Therapeutic Goods Agency, focused on sharing surveillance lists about API manufacturing sites. The shared reports influenced agency decisions about inspections and imports. The second pilot involved FDA and EMA and focused on good clinical practice. The two agencies exchanged more than 250 documents relating to 54 drug products and organized 13 collaborative inspections of clinical trials. 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 »

During this cost-conscious time, many patients and other healthcare payors are opting for generic versions of branded pharmaceuticals. Biopharmaceuticals have claimed a place in the spotlight, but the US currently has no regulatory pathway for biosimilars. That could change after FDA releases its final guidance on follow-on biologics later this year. Read more »

It’s a well-known fact that new product approvals in the pharma industry have been in decline in recent years. In 2010, for instance, the FDA only approved 21 new drugs compared with 26 and 24 in 2009 and 2008, respectively. July 2011, however, saw the FDA approve its twenty-first product for 2011 with AstraZeneca’s blood-thinner Brilinta, so it seems as if the agency is set to outpace 2010’s dreary approval numbers. Read more »

The past decade has been marked by a series of large mergers between medium and large pharmaceutical companies. Such mergers are attractive from a short-term business perspective, in that they result in instant growth, a pumped-up pipeline, and bigger dividends for shareholders. No company embraced this strategy with as much enthusiasm as did Pfizer. Over the course of a decade, Pfizer initiated three large mergers: with Warner-Lambert in 2000, Pharmacia in 2003, and Wyeth in 2009, and in addition, made numerous smaller acquisitions. Now that the deals are done, and the dust has settled, the industry is beginning to evaluate whether mega-mergers have been good for business over the long term. Read more »

In 2008, a shortage of pig intestines, used in the manufacture of the blood anticoagulant heparin, was associated with the drug product’s contamination in China and led to many deaths around the globe. This event demonstrated the significance of a shortage of supplies needed to manufacture a particular drug and its effect on public health. Read more »

Identifying influenza strains each year and developing the appropriate vaccines to combat those strains has been the strategy of combating influenza, including potential pandemics. Finding a way to develop a universal vaccine has been a desired, but elusive goal, but several researchers have recently reported on promising developments for developing a universal influenza vaccine. Read more »