FDA approves Genentech skin cancer drug
SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating the most common type of skin cancer, the agency said Monday.
The FDA announced the approval of Genentech’s Erivedge (vismodegib) for adults with basal cell carcinoma who are not surgery or radiation therapy candidates and whose disease is locally advanced or has spread to other parts of the body.
The drug works by inhibiting the Hedgehog pathway, which is active in most basal cell cancers and only a few normal tissues, such as hair follicles. The disease generally is a slow-growing and painless cancer that starts in the top layer of the skin and develops in areas regularly exposed to sunlight or other ultraviolet radiation.
"Our understanding of molecular pathways involved in cancer, such as the Hedgehog pathway, has enabled the development of targeted drugs for specific diseases," FDA Office of Hematology and Oncology Products director Richard Pazdur said. "This approach is becoming more common and will potentially allow cancer drugs to be developed more quickly."
NACDS, NCPA urge guidance for states on Medicaid reimbursements
ALEXANDRIA, Va. — Two groups representing the retail pharmacy industry are urging the federal government to provide guidance to the states on how to adjust Medicaid dispensing fees to determine pharmacy reimbursement.
Following a meeting with the Centers for Medicare and Medicaid Services, the National Association of Chain Drug Stores and the National Community Pharmacists Association sent a letter to the agency stressing what they called the importance of providing the guidance promptly, before the government finalizes current draft federal upper limits based on average manufacturer price.
"Addressing pharmacy reimbursement comprehensively, both the cost of the drug product and the cost of dispensing, is critical to maintaining access to pharmacy services for our Medicaid patients," read the letter, signed by representatives of both groups and addressed to Cindy Mann, CMS administrator and director for the Center for Medicaid, CHIP and Survey and Certification.
In addition, NACDS said it was reviewing a rule proposed by CMS on Medicaid pharmacy reimbursement using the AMP model, which the Patient Protection and Affordable Care Act redefined. "NACDS is currently reviewing the proposed rule with its members and will provide comments to CMS based on this analysis," NACDS president and CEO Steven Anderson said. "However, NACDS has long expressed concerns with using AMP as a basis for pharmacy reimbursements, as it is not a price paid in the marketplace but instead is a benchmark to determine manufacturer rebates in the Medicaid program."
Click here to read the letter.
Check out the full proposed rule from CMS here.
Actavis partners with Poland’s Bioton to develop insulin products
WARSAW, Poland — Iceland-based drug maker Actavis and Poland-based Bioton have formed a partnership that they said would "shake up" the diabetes market.
Actavis and Bioton announced the signing of a $73.3 million deal to develop, manufacture and commercialize insulin products, including insulin analogues. Of that, Actavis will pay $29.4 million to Bioton when the deal is signed, while the rest will consist of milestone payments.
Under the deal, Bioton will develop and manufacture the products, while Actavis will commercialize them under its brand in the United States, the European Union, Japan and several non-E.U. European countries. Both companies will sell the drugs under their respective brands in Poland.