Patricia Van Arnum was executive editor of Pharmaceutical Technology
Janssen-Cilag International, part of Johnson & Johnson (J&J) is working with regulatory authorities in five countries to address the trace amounts of 2,4,6-tribromoanisole (TBA) that were identified in five batches of the HIV?AIDS medicine Prezista (darunavir). The countries affected include the United Kingdom, Ireland, Germany, Austria, and Canada.
The Office of the United States Trade Representative (USTR) issued a report, 2011 Special 301 Report, as part of its annual review of the global state of intellectual-property rights (IPR) protection and enforcement. The report was issued earlier this month and addresses IPR protection and enforcement, and specific initiatives by the United States, its trading partners, and international bodies, including measures relating to drug anticounterfeiting and market access to medicines.
The Pharmaceutical Research and Manufacturers of America (PhRMA) urged Congress to reauthorize two pieces of legislation relating to pediatric studies and exclusivity, the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA). PhRMA made the comments in testimony in a public meeting before the Institute of Medicines (IOM), the health arm of the National Academy of Sciences.
Shanghai Pharmaceutical and Pfizer have signed a memorandum of understanding for the companies to jointly pursue potential business opportunities in China.
Merck Forms Joint Venture with Sun Pharmaceutical
AstraZeneca Agrees to $1.1-Billion Settlement to US and UK Tax Authorities
Merck Sells Contract Biopharmaceutical Business to Fujifilm
President's Budget Allocates More Funding to FDA
GlaxoSmithKline (GSK) issued a statement on Jan. 2, 2011, to respond to a 60 Minutes segment that aired on Jan 2 that focused on quality-control problems at a former GSK manufacturing facility in Cidra, Puerto Rico. The segment focused on an interview with former GSK employee Cheryl Eckard, who detailed the problems at the facility and which eventually resulted in a $750-million settlement between GSK and federal and state governments that was announced in October 2010.
