Apparently, the Bextra (valdecoxib) nightmare is lingering a bit longer for Pfizer. More than four years after the initial lawsuits against the drug were filed, a sales executive of a separate company pleaded guilty yesterday to encouraging her sales staff to promote the painkiller for uses she knew had been rejected by the US Food and Drug Administration. Read more »

Janet Woodcock, director of the Center for Drug Evaluation and Research for the US Food and Drug Administration, spoke at the Drug, Chemical, and Associated Technologies Association (DCAT) annual dinner earlier this month, emphasizing the need of regulators and industry to meet the challenge of securing an increasingly complex global pharmaceutical supply chain. Her words were very well taken and show the recognition not only by FDA and other regulatory authorities, but also of pharmaceutical manufacturers and their suppliers, that the elongation of the global supply chain brings with it new responsibilities and ways of doing business. Read more »

As an editor for Pharmaceutical Technology, I often hear about novel drug-delivery mechanisms. Often they’re high-tech materials such as polymers, hydrogels, or nanoparticles. But a recent Associated Press story revealed a biological-based drug carrier that I hadn’t thought of: fish. Read more »

Perhaps drug manufacturers, packers, distributors, and applicants have a lot of free time on their hands. Or, perhaps they wisely support the collection of adverse event reports tied to their products. Either way, pharma didn’t seem to have any problems with FDA’s annual information collection provisions, announced Dec. 16, 2008, and reissued Mar. 13, 2009, in the Federal Register. Read more »

When faced with determined opponents, sports teams sometimes work the referees to win the game. A victory based on an interpretation of the rules is a victory nonetheless. The team of Warner Chilcott (Rockaway, NJ), Medicis Pharmaceutical (Scottsdale, AZ), Roche (Basel), and Stiefel Laboratories (Coral Gables, FL) recently used this tactic in their competition with generic drugmakers. The companies filed citizen petitions with the US Food and Drug Administration in an attempt to delay the approval of generic versions of their antibiotics. Read more »

Pharmaceutical Technology magazine presents part two of its vidcast program, recorded at INTERPHEX 2009. Click the links below to watch the vidcasts. (Click here to see day one of the vidcast program.) Read more »

Pharmaceutical Technology magazine presents part one of its vidcast program. Today’s edition brings updates from the show floor of INTERPHEX 2009. Click the links below to watch the vidcasts. Read more »

A representative from Pharmtel Corp in China spoke to the INTERPHEX audience this morning at New York City’s Javits Center about why US pharmaceutical investors should come to China. Unfortunately, his presentation was not very convincing. Read more »

Yesterday at INTERPHEX, attendees had the opportunity to meet representatives from the category winners of the Facility of the Year Awards (FOYA) at a reception. The awards program, now in its fifth year, recognizes companies that advance pharmaceutical manufacturing technology. Read more »

More than 10,000 people registered to attend INTERPHEX 2009–taking place this week at New York City’s Javits Center–and even throughout the St. Patty’s Day celebrations, the conference vibe is business, business, business. Perhaps it has something to do with the economy, but as RJ Palermo, industry vice-president of INTERPHEX, points out, if you’re only able to attend one show this year, this is the one to be at. Read more »