Monthly Archives: December 2003

Drug companies make patent concessions
AIDS activists hailed a breakthrough agreement with two of the largest drug companies in South Africa Wednesday, saying it will help more poor people get vital medicines. They cited the Canadian government’s decision to override patent law for essential drugs for Africa as one key factor in persuading the pharmaceutical makers to loosen their hold on patents.

FDA, Industry Collaborate On Genomics Guide
Last month, the FDA issued its long-awaited draft guidelines for pharmacogenomic data submission. Companies large and small have been anxious to get their hands on these guidelines, for they are a critical starting point in the agency’s efforts to come up with the most appropriate requirements for pharmacogenomic data as part of a new drug application (NDA), a biologics license application (BLA) or even an investigational new drug application (IND).

Food Biotech Is Risky Business
The genetically modified food industry has battled opposition from consumer and environmental groups to get its food on the table. Its lobbyists have cajoled skeptical politicians; its scientists have produced studies contradicting other studies suggesting the food is somehow tainted.
Now the industry faces another hurdle with long-range, dire consequences: It may be uninsurable.