After the FDA took the unusual step of seizing 1,300 Alaris SE infusion pumps manufactured by Cardinal Health, the company shut down its factory line. The company says 140,000 of the devices are on the market but pose no serious threats to patients. The company and the FDA agree the…more...

Oracle bought the intellectual property assets of Sigma Dynamics Inc. Oracle said San Mateo-based Sigma developed real-time predictive analytics technology. No details about the transaction were disclosed. But Oracle did say that Sigma Dynamics has been the underpinnings of the Siebel Real-Time Decisions product, which Oracle recently acquired in a…more...

The FDA reversed itself and approved Barr Pharmaceuticals’ Plan B as an over-the-counter contraceptive. The move was widely anticipated and reflects the Bush administration’s desire to advance the stalled nomination of Andrew von Eschenbach as FDA head. The Bush administration, under pressure from anti-abortion activists in the conservative wing of…more...

Lawyers suing Merck have put together a way to lower the cost of attacking the drug company. The pre-packaged Vioxx workbook can shave the cost of suing Merck from $1 million to just $50,000. There are already 10,000 cases pending against the company, but the new arrangement could open the…more...

The Clinical Data Interchange Standards Consortium is conducting a survey of data standards in clinical trials. Respondents should fill out the one-page form by April 19, 2006. Among the questions being asked, one includes the very specific use of eight different formal or draft versions of CDISC standards. The Gartner…more...

Insightful Corp. is rolling out the beta software for S-Plus. Insightful calls the program its next major release for statistical data analysis and predictive analytics. The beta program will be conducted on S-Plus 8 Enterprise Developer and will be available until August 31, 2006. New features under consideration include: language…more...

Technology to track individual genetic variation in clinical trials is being more widely used. The latest deal Illumina announced is a $7 million genotyping services agreement to support prostate cancer, with researchers funded by Cancer Research UK, a charity.Illumina’s service group will conduct whole-genome genotyping (greater than 550,000 single nucleotide…more...

The post-approval market is heating up. Clinipace, of Research Triangle Park, North Carolina, announced its newest client, Medical Carbon Research Institute (MCRI). MCRI is a biomaterials and medical device manufacturer in Austin, Texas, and will use Clinipace’s clinical data capture and trial management technology, Tempo, to run a Phase IV…more...

etrials revenue rose 7 percent, to $14 million. The company recorded a loss for the 2005 year. Among other tidbits, the latest financial statement shows that etrials paid $420,000 to settle a lawsuit with PHT, an electronic patient diary company. The company has working capital of $20 million and predicts…more...

Afferenz, a leading Indian e-clinical software suite company, announced the appointment of David Olson and Daniel Weddle to its sales team. Olson brings more than 30 years of experience in the pharmaceutical and life sciences industry to his role at Afferenz focusing on pharmaceutical, biotechnology and medical device sponsors. Olson…more...