FDA approval of Genentech/Curis’ first-in-class Hedgehog inhibitor Erivedge (vismodegib) for advanced basal cell carcinoma also marks the first approved treatment option for the common skin cancer and the first marketed drug to come out of the Lexington, Mass, biotech.
Cell Therapeutics pulls pixantrone NDA ahead of FDA advisory committee review.
FDA sent an untitled letter to Celgene objecting to a white paper Abraxis distributed at the American Society of Clinical Oncology’s annual meeting in June 2010. Celgene acquired Abraxis in October 2010. FDA’s Office of Prescription Drug Promotion said the paper makes unsubstantiated claims about the effectiveness and superiority of Abraxane, promotes the drug for unapproved uses and lacks full approved labeling.
CMS proposed rule on the average manufacturer price for drugs proposes to include specialty and home infusion pharmacies in the law’s definition of “retail community pharmacy” for the purpose of calculating AMP, citing drugs subject to FDA’s Risk Evaluation and Mitigation Strategy as the reason.
Thirteen biopharmaceutical companies will join with the Bill Gates Foundation, the World Bank, global health organizations and governmental bodies to fund an $875 million effort to eradicate or control 10 neglected tropical diseases by 2020. Under this agreement, pharma companies will continue, expand or initiate drug donation programs as well as share compounds and drug-development knowledge with the Drugs for Neglected Diseases Initiative to address the 10 diseases
