Like a snowball that gets bigger and bigger as it hurtles down the side of a mountain, generic drugs pose an increasingly large threat to branded pharmaceutical companies. Wolters Kluwer Health’s annual analysis reveals that more than 60% of all US prescriptions filled in 2008 were generics. For orally administered medicines, the percentage was even greater. In 2008, 2.4 billion prescriptions were filled for generic drugs, and only 1.4 billion for branded therapies—an unprecedented divide, according to the report.

What’s Big Pharma to do? Read more »

Pfizer announced this week that following a successful completion of its $68-billion acquisition of Wyeth, it will divide its research activities into two separate organizations, one for small molecules and one for biologics and vaccines. The reorganization is but a microcosm of Big Pharma’s larger strategic interest to strengthen its position in biologics with the hopes of improving its return on research and development (R&D). But is the calculus of intensifying R&D into biologics correct? Read more »

The New England Journal of Medicine published three articles today on the subject of brown adipose tissue, or brown fat, in adults. Brown fat is considered a “good” type of body fat because it actively burns calories to make heat, unlike the “bad” white fat that simply stores energy and makes up most body fat. Read more »

According to the World Health Organization, a new active tuberculosis infection occurs every second, and as many as one-third of the world’s population may be asymptomatically infected. Despite efforts to create anti-TB drugs, multi-drug resistant (MDR) strains are rampant worldwide. Read more »

The New York Times suggested on Monday that the Obama Administration may already be influencing FDA to raise its oversight and enforcement activities. Perhaps the authors, Gardiner Harris and Andrew Martin, are on to something. Read more »

Pfizer (New York) has apparently agreed to settle allegations that it conducted an illegal clinical trial of its meningitis drug trovafloxacin in Nigeria. Eleven children died during the trial that prosecutors say was unlicensed. It would be impossible to establish drugs’ safety without clinical trials in humans, but the settlement agreement is more grist for those who say that trial patients’ rights and health are not sufficiently protected. How will regulators respond? Read more »

There is growing debate as to whether to divide the US Food and Drug Administration into two separate agencies, one with oversight over food regulation and the other to regulate drug safety and medical devices. Would such a reorganization create substantive change or would it merely be altering the façade of a regulatory body in need of much deeper repair? Read more »

Eli Lilly & Co. (Indianapolis) CEO John Lechleiter earlier this week told the Financial Times that he is not interested in becoming part of the recent mega-merger trend (see Pfizer+Wyeth, Merck+Schering-Plough and Roche+Genentech). Rumors and speculation have had some thinking Lilly+Bristol-Myers Squibb (BMS) would be the next big thing, but Lechleiter specifically ended rumors of that combination and remained critical of Big Pharma’s recent big deals. Read more »

Several medium- and large-sized pharmaceutical companies have gotten themselves into more trouble with FDA. The agency sent warning letters to nine companies yesterday (Mar. 31, 2009) requesting them to halt the production and distribution of 14 unapproved narcotics (mainly painkillers) (see the FDA’s release). The companies are: Boehringer Ingelheim Roxane (Columbus, Ohio), Cody Laboratories (Cody, Wyoming), Glenmark Pharmaceuticals (Mahwah, NJ), Lannett Company (Philadelphia, PA), Lehigh Valley Technologies (Allentown, PA), Mallinckrodt Pharmaceuticals Group (St. Louis), Physicians Total Care (Tulsa, OK), Roxane Laboratories (Columbus, Ohio), and Xanodyne Pharmaceuticals (Newport, KY). The drug firms have 60 days to stop manufacturing these products and 90 days to stop distributing them before enforcement action is taken. According to the FDA release, “previously manufactured products may still be found on pharmacy shelves for a short time.” Read more »