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Cell Therapeutics has filed for a special protocol assessment (SPA) with the FDA for the design of its Phase III trial of Xyotax for women with advanced lung cancer.
Basilea Pharmaceutica announced that the second pivotal ceftobiprole Phase III study in complicated skin infections met its primary endpoint of statistical non-inferiority versus combination therapy.
Join FDAnews Tuesday, Jan. 23, for "Pharma Marketing Laws: State by State: Strategies for Compliance with Patchwork Regulations." In this 90-minute interactive audioconference, Keith Korenchuk, attorney with Covington & Burling, will deliver clear guidance on the regulations in the three states (California, Florida and New Hampshire) that enacted new drug marketing laws in 2006, along with the states that already have drug marketing laws in place. On Feb. 1, join FDAnews for "Clinical Trial Billing Under Medicare: How the New National Coverage Decision Will Impact You." In this special 105-minute audioconference with Q&A session, noted attorney Mark Barnes will provide the information you need to receive reimbursement from the Centers for Medicare & Medicaid Services for clinical trial expenses without running afoul of the Office of Inspector General.
Roche announced it has received European marketing approval for a once-weekly dosage of NeoRecormon (epoetin beta) for subcutaneous injection for the treatment of anemia in patients with solid cancers receiving chemotherapy.
BioWa and Medarex have received FDA approval for their investigational new drug application for MDX-1401, a fully human antibody that targets CD30-positive lymphomas.
Anthera Pharmaceuticals announced that the FDA has approved its investigational new drug (IND) application for use of its lead compound A-001 in hospitalized patients with sickle cell disease.
Aida Pharmaceuticals has received approval from Chinese regulatory authorities to begin Phase II clinical trials of the genetic cancer treatment Rh-Apo2L.