On its 50th anniversary, PhRMA released 2007 R&D numbers. Clinical development costs, as far as we know, were not broken out. To compile the numbers, the organization had help from Burrill & Co., the California investment and research firm. Total spend for the members of PhRMA was up 2.5 percent, from $43.4 billion to $44.5 billion. Nonmembers spent another $14.3 billion. Here’s the release.

Contract research organization Synexus appointed Claire Lyons as feasibility manager. She’s a six-sigma “green belt” and has an analytical background in chemistry. Lyons previously worked at Sanofi-Aventis. Michael Fort, CEO of Synexus, comments: “Claire’s appointment is an important step in Synexus’ plans to expand globally and offer the most professional service. Claire will improve further our business development systems and processes ensuring that clients achieve their goals.” Here’s our recent story on the company.

Encorium reported quarterly and annual financial results. Net revenue for the final quarter of 2007 increased to $8.3 million from $6.1 million; the company reported a $732,000 loss during the period. Annual revenues doubled, reaching $31.7 million. Kenneth Borow, president and chief medical officer, stated, “We continue to evaluate a variety of acquisition possibilities and are focusing on companies and areas that would enhance Encorium’s existing geographic footprint and therapeutic area capabilities. We remain focused on expanding into emerging clinical trial markets outside North America and Europe as well as broadening our capabilities within targeted sectors such as oncology, endocrinology, and medical devices.” The company has a webinar for investors this morning, and there is a press release here.

Forbes has a long, meandering story on the Vytorin controversy. Data for a key trial will finally be released this weekend at the Chicago meeting of the American College of Cardiology. Here’s the link, which doesn’t clarify whether doctors will find the new data persuasive. Phase Forward and the Harvard Clinical Research Institute are also presenting at the cardiology meeting.

The state of California postponed the tracking of individual prescriptions with serial numbers. Pfizer is already doing that for a few frequently-counterfeited products. But the industry had complained that the California plan was premature and burdensome. In the second such delay, California agreed to wait at least until 2011, or perhaps until a separate FDA plan can be implemented nationally.  According to the Los Angeles Times, the FDA has been working on drug tracking for … 20 years. Here’s a story in the New York Times.

The FDA’s Janet Woodcock has been interviewed by the Financial Times. It appears to be one of her first media chats since being reappointed to her old job as head of CDER. Quoth the newspaper: “Woodcock conceded that the size and length of clinical trials had grown substantially in recent years but argued that was a result of better understanding by regulators of how best to identify risks. ‘We’re smarter now [but still] humbled by what we don’t know,’ ” Woodcock says. She puts some distance between the agency and the sponsor community: “We understand that [they] have productivity issues but [we] stick to the same safe and effective criteria as our bedrock. Pharma is having a difficult time but we are seeing drugs that have a lot of questions.” Here’s the link.

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