One of PharmTech’s columnists recently wrote about individuals working in quality assurance and how, after becoming more sensitized to a problem, they significantly increased their performance. Specifically, the employees were in charge of identifying spots on finished vials—if they found a spot of a certain size, they rejected the vial. When one employee starting finding more spots than usual and bragged to his colleagues, they all started finding more spots until the team was rejecting 20% of the finished vials. Read more »

The welter of recent product recalls (and phantom recalls) initially got the US Congress talking about the adequacy of Johnson and Johnson’s (J&J, New Brunswick, NJ) manufacturing and quality-control operations. But lawmakers soon began asking questions about our line of defense against potentially harmful products: the US Food and Drug Administration. Read more »

Publicity about substandard or contaminated products usually lights a fire under pharmaceutical companies, which then race to address their compliance problems. But a new US Food and Drug Administration inspection report shows that, despite a stream of product recalls and a Congressional investigation, Johnson & Johnson (J&J, New Brunswick, NJ) has not gotten its house in order yet. And the company’s latest problems conceivably could make things hot for one of its partners. Read more »

The European Union had all the right goals in mind when they launched the Innovative Medicines Initiative* (IMI) in 2007.  In an effort to boost the floundering pharmaceutical sector, leaders decided to bring together public and private scientists across Europe to research and develop new drugs.

 According to an analysis of the program in the July 13 issue of Nature, IMI received 138 “expressions of interest” from universities and research institutes when it first called for research-project proposals.  The second call turned out 124 proposals.  IMI’s executive office in Brussels believes these numbers are a “resounding success,” says the Nature report.  But a joint letter from a group of 11 university and research organizations, including EARTO —which is the European trade association for more than 350 research and technology organizations—states otherwise, calling the first two call responses “well below potential.”

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It looks as though pharma is following GlaxoSmithKline’s lead in increasing efforts to provide people in developing countries with access to needed medications. GlaxoSmithKline (GSK, London), led by CEO Andrew Witty, has been on the forefront of this effort for some time—its largest contribution being the availability to the public of 13,500 malaria compounds for research and development (see  back story, “GSK Promotes Open Innovation, Help for Developing Countries”). Read more »