Sanofi may bid for Crucell; FDA opens Costa Rica office;

> French newspapers are reporting that Sanofi-Aventis is eyeing a bid for vaccine maker Crucell, which made news this week when it confirmed that it was in buyout talks with Wyeth. Report [1]

> A year after announcing plans to open offices overseas--part of the "Beyond Our Borders Initiative," the FDA has a site in Brussels, three offices in China [2] and has now officially opened its doors in San José, Costa Rica. Report [3]

> The FDA wants more data from Merck before making a decision on whether or not to expand the indication of the HPV vaccine Gardasil for use in women ages 27 through 45, Merck announced today. Report [4]

> XDx, a molecular diagnostics company, announced today that it has signed a collaborative pharmacogenomics agreement with Bristol-Myers Squibb. The collaboration is focused on identifying biomarkers for clinical diagnostic purposes associated with the clinical development of Orencia (abatacept), a BMS drug approved for the treatment of rheumatoid arthritis. Release [5]

> CRO ICON has lowered its 2008 revenue forecast. The company is now predicting a revenue range of $862 million to $865 million, down from the $870.75 million analysts had predicted. Icon said currency changes are to blame. The company also announced that it has bought the remaining shares of Beacon Biosciences, 70 percent of which it acquired in 2004. Release [6] l Report [7]

> Equipment upgrades at Merck's West Point, PA-based vaccine plant will cause shortages of its hepatitis B vaccine Recombivax HB for adults. Report [8]

> Eli Lilly announced Wednesday that the FDA has delayed approval of a long acting version of its schizophrenia drug olanzapine pending a proposal for a Risk Evaluation and Mitigation Strategy (REMS). Report [9]

> Vivaldi Biosciences, a biotechnology company focused on the development of vaccines for influenza, today announced that it has received binding commitments for $23 million in a Series A Convertible Preferred Stock financing. Release [10]

> RegeneRx Biopharmaceuticals reported mixed results for its Phase II clinical trial evaluating the safety and wound-healing efficacy of RGN-137 for the treatment of patients with chronic pressure ulcers. The drug was safe and well-tolerated, with no adverse events, but data showed no significant difference in wound healing or healing rate between the placebo and RGN-137. Release [11]

> Osiris Therapeutics received a $5 million milestone payment for reaching the first production threshold of the Osteocel supply agreement with NuVasive. Release [12]

> Merck and Schering-Plough got a boost from the FDA yesterday: The agency said patients using the cholesterol med Vytorin shouldn't stop taking the drug despite questions that have arisen since a two controversial studies were released last year. Report [13]

[9]

And Finally... FDA scientists have lobbed a bombshell into the debate over new leadership and reform at the agency after President-elect Obama takes office. According to a letter nine of them wrote to Obama's transition team, sweeping changes are necessary at the agency to banish a corrupt, anti-scientific culture. Report [14]