DSG, Omnicare, ClearTrial
Thursday’s News
Briefs for July 5th.
The contract research organization (CRO) PPD unleashed enough news for a year this week. The company announced a long list of new directions, ominous numbers and strategic shifts, including: • The company's quarterly earnings (not great, but not terrible); • The planned acquisition of the Chinese CRO Excel PharmaStudies, which will make PPD a major player in China; • The intent to spin off its compound-partnering business into a separate publicly traded company in early 2010; • The investment of $100 million ($30 million now, the rest later) in Celtic Therapeutics, an investment fund that focuses on therapeutic product candidates. • A new contract with the FDA to evaluate the agency's Center for Drug Evaluation and Research (CDER) post-market spontaneous adverse event surveillance system. Wow. PPD's executive chairman Fred Eshelman told Wall Street it's all part of a plan with “so many details and moving parts” to establish the company as…more...
There is lots of buzz about China being the next hot place for global clinical trials. The numbers being bandied about suggest $2 billion in Chinese pharmaceutical research and development in…more...
There are more active, commercial investigational new drug applications (INDs) circulating through the FDA than ever. Exactly 5,700 at the end of 2008. That's a record high—up 20 percent over the…more...
Top contract research organization Kendle reported a strong quarter but told Wall Street future profits would be lower than expected. Quarterly revenues jumped 33 percent to $100 million. The company lined…more...
ClinPhone, a leading clinical technology suite, has been granted a Best Technological Development in Clinical Trial Management Systems Award for its drug accountability solution at the inaugural GCPj Awards 2007. The Good Clinical Practice Journal Awards were developed to recognize corporate and individual excellence and celebrate innovation. Bill Byrom, vice president, product management, said: “ClinPhone’s drug accountability…more...
CDISC annointed Omnicare Clinical Research registered Registered Solutions Provider status. Said the company’s Mark Penniston, global VP of Biometrics: “Since our first CDISC conformant submission in early 2004, Omnicare Clinical Research has had a rich history of successful data conversions. We recognize the importance of CDISC standards and have invested in providing on-line, up-to-date training for all…more...
In Nevada, a jury ordered Wyeth to pay $135 million to three women who took Premarin and Prempro. The jury said Wyeth acted with malice or fraud. Wyeth has no reserve fund for its hormone replacement therapy (HRT) cases, possibly because it has spent tens of billions of dollars to settle fen-phen litigation. The jury apparently was…more...
Covance expanded its facilities in Singapore for food manufacturers in the region. Manufacturers operating in Asia to export food to the U.S. will soon be able to send samples to a laboratory in Singapore. Chinese state media stated that the Singapore lab will initially focus on the testing of infant formula for release, stability and labeling data,…more...
Briefs for July 5th.
A leading technology supplier talks about China.
The CRO is marching across Asia, among the first to use Clintrial there.
A real-world story of an e-diary study in the U.S. and Eastern Europe.
In November, the company named two new executives to shepherd its push into Japan: Tetsushi Inada and Kevin Keim.
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