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 »

In a speech last week to the City Club of San Diego, John Lechleiter, chairman and chief executive officer of Eli Lilly, offered very candid remarks about the state of innovation in the pharmaceutical industry, saying that the engine of biopharmaceutical innovation is “broken.” His comments may be a bitter pill to swallow in light of escalating investment in research and development (R&D), but his frankness may just be the remedy the industry needs to reinvent itself. 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 »

We’ve all heard that quality by design and science/risk-based approaches to pharmaceutical manufacturing require a paradigm shift among industry. Well, that message was reinforced again today at the 3rd Annual Pharmaceutical Technology Conference in Philadelphia, PA. Read more »

Reading the news sometimes gives me a disorienting sense of déjà vu. I know I wrote that last week, but it’s true again for a different reason. Today, French heavyweight sanofi aventis (Paris) announced that it was acquiring a majority stake in Shantha Biotechnics (Hyderabad, India). This new development follows a now-familiar pattern. Read more »

To no one’s surprise, Wyeth shareholders approved yesterday the $68-billion merger agreement with Pfizer. The vote was overwhelming: 98% in favor. The final step is the approval by the Federal Trade Commission and international regulators. The mega deal, one in three this year (Merck and Schering Plough; and Roche and Genentech) emphasizes the bottom-line industry mantra: diversify to compete. Read more »

The shift in stem-cell policy by the Obama administration and ensuing federal guidelines for human stem-cell research is creating renewed interest in the potential of regenerative medicine as a therapeutic option. As a case in point, the advocacy group, the Alliance for Regenerative Medicine, was formed earlier this month to promote regulatory, research, and reimbursement policies that will foster innovation in regenerative medicine. The alliance, which includes universities, life-science companies, and healthcare investors, will also serve as a source of information about regenerative medicine for policymakers, the media, and the general public. As the bioethics of certain types of regenerative medicines are debated and its scientific potential evaluated, a bottom-line question arises. Can regenerative medicine generate sufficient financial returns to make it a viable option for the pharmaceutical industry? Read more »

The US Food and Drug Administration announced yesterday it is requiring a black box warning for two drugs used to aid smoking cessation, Chantix (varenicline, Pfizer, New York) and Zyban (bupropion, GlaxoSmithKline, London). Read more »

German authorities busted a counterfeit-drug ring yesterday selling fake Viagra (Pfizer, New York) via Internet pharmacy websites, according to an Agence France-Presse report. After a months-long investigation involving 60 customs officers, seven prosecutors and 25 tax investigators, raids in five cities produced 46,000 counterfeit Viagra tablets, frozen bank accounts in Austria, Switzerland, Spain, Belgium, France, and Turkey, four confiscated luxury vehicles, 15,000 euros ($21,000) in cash, and four people in police custody. Read more »

The first-ever BRIC Economic Summit was held this week in Yekaterinburg, Russia, further signaling the importance of Brazil, Russia, India, and China, collectively known as the BRIC countries, in the current and future direction of the global economy. Some predict that the BRIC countries will surpass the leading economies by 2050, according to a recent New York Times article. The seeds of change already have been planted in the pharmaceutical industry, where pharmaceutical market growth in emerging economies is projected in the double-digits in 2009, compared with declining to anemic growth in established markets. Big Pharma is attuned to the shifting market dynamics. Many companies have clearly stated their strategic intent to enhance their positions in emerging markets. But what are the implications for pharmaceutical manufacturing? We may have gotten a glimpse into the future with some recent moves by Pfizer and GlaxoSmithKline (GSK). Read more »