Specialty pharma Cobalis will delay reporting trial results because of concerns about the quality of data from electronic patient diaries. Cobalis’s two similar Phase III allergy trials had a total of 1,551 patients and 23 sites. Here’s a quote from the press release: “Given inconsistencies it has identified, the company does not know at this time which data are correct, and it said it must review source documents and conduct other quality control measures.” Sounds like quite a muddle.

MDS Pharma has decided to continue the consolidation of its Canadian operations, putting an end to key activities at its Montreal facility. It will cut 160 jobs there. The decision comes three months after MDS undertook a similar scale-back process at its Quebec City plant. The contract research organization (CRO) will cease drug metabolism and pharmacokinetics (DMPK) operations in Montreal by the end of August, eliminating around 40 positions. This consolidation puts an end to years of crisis for MDS Pharma that started in 2003, when the U.S. Food and Drug Administration (FDA) inspections of the company’s two Canadian plants found a range of problems with its pharmacokinetics testing procedures. Those included failure to identify and fix sources of contamination in bioanalytical tests. According to the FDA, more than 1,000 brand-name and generic drugs that have been approved or submitted for approval since 2000 may have included MDS data in their paperwork. The agency won’t rescind any approvals, but pending applications could be delayed.

China gave the death sentence to its top food and drug official Zheng Xiaoyu for taking bribes worth over $830,000. Ten deaths resulted from one antibiotic that Zheng approved. That’s a bit more severe than what happened to ex-FDA head Lester Crawford earlier this year. After lying about investments, Crawford resigned. He was sentenced to pay a $90,000 fine and perform 50 hours of community service. There’s no word on whether Crawford—now a top Washington lobbyist—will campaign for leniency in Zheng’s execution.

Clinical trial technology suite Phase Forward was ranked 21st on the Boston Globe 100 list of top public companies in Massachusetts. The ranking was based on financial data for the four quarters ending December 31, 2006.

Tom Sturgis, president of Integrated Clinical Trial Services (ICTS), a company providing innovative and efficient patient-oriented solutions to the clinical research industry, has announced the release of a podcast discussing Good Clinical Practice (GCP) training programs. In the podcast, Gregg Sweet, vice president of strategy and development at ICTS, discusses participation in investigator meeting GCP training, how video programs produced by ICTS can actively engage the investigators, the benefits for sponsors and the positive feedback ICTS has received on its video program. The podcast is now available for download.

Image Solutions, a provider of software and services to streamline the drug development life cycle, announced the opening of new operations in Tianjin, China. Image Solutions’ expansion in Asia supports the company’s overall commitment to support the globalization of the life science industry. Image Solutions can now link multiple offices located in different time zones, and use Web-based technology to provide almost 400 man-hours of production time within a single 24 hour day. This capability provides Image Solutions with a unique competitive advantage to meet client time frames and achieve their goals quickly and cost-effectively.

Pfizer is in a brawl with Nigeria—and journalists at the Washington Post. This week’s news is that Pfizer is facing a $2 billion civil suit and criminal charges. A controversial 1996 pediatric clinical trial of the antibiotic Trovan had 11 deaths, but they have not been tied to the drug. Even so, the research sparked riots in Nigeria and inspired The Constant Gardener, John Le Carre’s novel and film. One Post charge is that Pfizer fabricated an ethics board’s letter of approval to begin the trial long after it was finished. “The suit charges that parents were barred from Pfizer’s ward and that the company’s own lab tests had shown Trovan’s life-threatening side effects,” the newspaper alleges. It’s unclear whether informed consent procedures were followed, or whether the dosage of the comparator drug was ethical.

•  The most serious issue: did Pfizer know in 1996 that the drug had significant hepatoxicity issues? That was clear by the late 1990s. But Pfizer’s scientists presumably did not have access to a time machine. Pfizer strongly disputes any misconduct charges, noting the meningitis epidemic was already an emergency when its physicians were called to the ancient city of Kano. In fact, the company insists, it saved “almost 200” children in Nigeria. Trovan was rejected by European authorities and never approved for use in children by the FDA.

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