FDA to review Ranexa for supplementary use as angina treatment
PALO ALTO, Calif. The Food and Drug Administration will review CV Therapeutics chest pain drug Ranexa as an initial treatment for angina, according to the Associated Press.
The drug was originally approved as a treatment for chronic angina in patients who had not responded to other anti-anginal drugs. The biopharmaceutical company is also looking for label changes to reflect a reduction in cautionary language.
Separately, the FDA will review a new drug application for Ranexa; CV Therapeutics is seeking a label change for the drug that says it also reduces the levels of hemoglobin HbA1c in coronary artery disease patients with diabetes. Hemoglobin HbA1c reflects the level of glucose in the blood.
The company said the FDA has agreed to make a decision on both applications on July 27, 2008.
Celgene to acquire Pharmion for $72/share
SUMMIT, N.J. Celgene and Pharmion have announced a merger agreement, under which Celgene has agreed to acquire Pharmion. Celgene will acquire all of Pharmion’s outstanding shares of common stock for $72 per share payable in cash and share of Celgene common stock.
Under the agreement, Celgene will acquire the rights to three popular Pharmion oncology drugs: Revlimid, Thalomid, and Vidaza. Thalmoid and Revlimid are used to treat patients with multiple myeloma. Vidaza is used to treat myelodysplastic syndromes.
“The acquisition of Pharmion is an exceptional strategic fit that will expand our role as a leader in hematology and oncology,” said Sol Barer, chairman and chief executive officer of Celgene Corporation. “Our combined global infrastructure will leverage the therapeutic and commercial potential of Pharmion’s products, particularly Vidaza, which has the potential to become a major global therapy. By bringing together the talents and resources of both companies, we move closer to our vision of becoming a leading hematology and oncology company in the world, expanding our industry leading programs for safety, access and patient support.”
RxHub introduces Rx 4 Success e-prescribing program
ST. PAUL, Minn. RxHub, a company that keeps track of patient-specific medication history and pharmacy benefit information, has announced a new product for e-prescribing, the Rx 4 Success.
The new program was developed to target four main areas of e-prescribing: utilization of Centers for Medicaid and Medicare Services approved ePrescribing transactions including eligibility, formulary and benefits, and medication history. The program will also integrate true electronic delivery of prescriptions to retail and mail order pharmacies. It will also keep consistent rules-based applications of clinical decision support content and formulate transactional data to support the development of outcomes based on pay-for-performance programs.
“We are extremely proud to be associated with our growing roster of partners which includes many of the healthcare industry’s foremost technology innovators,” stated Doug Johnson, vice president of business development for technology partners at RxHub. “Their collective vision not only helped shape Rx 4 Success but provides the foundation for ongoing market driven performance analysis and improvement.”
Rx 4 Success will become a participation requirement for technology partners connected to the RxHub network as of July 31, 2008.