Encorium reported financial results for the quarter. Revenues rose 8 percent, to $8.9 million. But the company’s loss increased by 200 percent, to $3.8 million. The company’s new CEO, David Ginsberg, is optimistic about European projects and the future: “Recent new business wins include contracts in the therapeutic arena of oncology, which is a recent focus for Encorium, and demonstrates how our increased business development efforts are starting to pay off.” Here’s a release.
A Chicago newspaper says drug prices are headed lower in a new political climate. Laws to allow drug reimportation and generic biologics are also likely to move through Congress in an Obama administration, it says. “We are likely to see some movements with prescription drugs and pricing,” said David Dranove, a business school professor at Northwestern University. “We are getting prepared for anything and everything next year,” said Ken Johnson, senior VP at PhRMA. Here’s the article.
European officials issued a report that criticized pharmaceutical companies for patent mischief to block generic competition. “The Commission will not hesitate to open antitrust cases against companies where there are indications that the antitrust rules may have been breached,” said Neelie Kroes, European commissioner for competition policy. It could be a harbinger of a campaign against a new industry. European authorities now generally set the global agenda for chemical regulations, and have been the only officials in the world inclined to impose restraints on American technology firms such as Microsoft and Google. Here’s a release.
Cardiologist Robert Califf of Duke University is being touted as a contender for the top job at FDA in this article, which says the Democrat was considered by Bush administration officials for the same job in 2001. Not incidentally, like one or two other members of Obama’s team, he’s a former college basketball star.
There are two acronym-heavy data standards bulletins today, both signalling a convergence of IT systems for hospitals and clinical trials sponsored by the pharmaceutical industry.
First, the Clinical Data Interchange Standards Consortium CDISC, NCI and other organizations released a new version of a forward-looking data model called Biomedical Research Integrated Domain Group, which is intended to help align clinical trial systems with general hospital and physician computers. The new version of the data scheme adds ways to structure information about clinicaltrials.gov, protocols and eligibility criteria. It also uses HL7 v3 data types. Here’s the home page for the effort.
Next, the Electronic Health Record Clinical Research Value Case Workgroup has been formed, with CDISC’s Becky Kush and the National Cancer Institute’s Gregory Downing named as co-chairs. The group is hoping to continue the work of a federal health data standards group. Fran Schrotter, senior VP and COO of the American National Standards Institute (ANSI), said: “This workgroup has an important opportunity to ensure that clinical research needs are addressed in the work that is done within [the Healthcare Information Technology Standards Panel] to harmonize EHR standards.” Here’s a release and an article.
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