Last week, Genzyme’s (Cambridge, MA) Allston Landing, Massachusetts, plant resumed production of Cerezyme, the company’s treatment for Gaucher’s disease. Genzyme presumably found and eliminated the source of contamination that had been reported weeks earlier. You’d think that after putting out this latest fire at the troubled plant, the company would be justified in heaving a sigh of relief. Read more »

Technology is not the answer, at least not for tackling pharmaceutical counterfeiting. Instead, increasing criminal sanctions and encouraging relevant parties to work with “certified and reliable partners” are the real solutions. Read more »

The US Agency for International Development (USAID) and the US Pharmacopeial Convention (USP) recently announced a new program designed to fight the growing problem of substandard and counterfeit drugs in developing countries. Read more »

In a news release issued by the European Organisation for Rare Diseases (EURORDIS) this week, the society commended the European Medicines Agency (EMEA) in its efforts to make the information that it has available on medicines more patient-friendly. Read more »

This week, the European Federation of Pharmaceutical Industries and
Associations (EFPIA) launched a two-month pilot project in Sweden designed to test a serialization and verification system in pharmacies that would fight counterfeit drugs. Read more »

Pharmaceutical brands face an increased threat online, according to a new report by the brand-protection firm MarkMonitor. The study, Brandjacking Index: Summer 2009, focused on six leading drug brands and examined these key areas of pharmaceutical brand abuse online: illicit pharmacies, listings on B2B exchange sites, and cybersquatting, or the abuse of a trademark within a domain name. Read more »

Fall is upon us and so is the awards season. And I’m not talking about the Emmy’s (although kudos to Mad Men). Earlier this month the Lasker Foundation gave out its Basic Medical Research Award, its Lasker-deBakey Clinical Medical Research Award, and the Mary Woodard Lasker Award for Public Service (see the Lasker Foundation website for more information). Next week the Nobel Committee will announce its award winners.

But last night belonged to the Pharmaceutical Industry. Read more »

Following up on last week’s post, it appears that the H1N1 flu vaccine is effective in older children, ages 10 to 17, based on preliminary results of an ongoing trial. This week, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, announced that early results of clinical studies of the vaccine “look promising.” Read more »

The US Food and Drug Administration approved on Tuesday four H1N1 flu vaccines that demonstrated in clinical studies that a single dose produced a strong immune response in healthy adults after 8–10 days. Based on the manufacturers’ production schedules, things seem to be on track for vaccines to be available in four weeks.

But clinical trials of the vaccine are still underway on pregnant women and children, two groups that the Centers for Disease Control and Prevention (CDC) says are especially vulnerable to the H1N1 flu. Read more »

Last month, US Food and Drug Administration Commissioner Margaret Hamburg announced the agency’s six-point plan for tougher enforcement of its policies and regulations as means of protecting public health. The plan, which includes actions like setting postinspection deadlines, speeding the Warning Letter process, and working more closely with FDA’s regulatory partners, was designed to “to prevent harm to the American people,” as Hamburg said in an FDA release. 

The agency has been actively involved in several recent cases involving instances of illegal importation and sales, drug diversion, and misbranding of drug products. Read more »