FDA approves Pfizer’s Inlyta for advanced kidney cancer
SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Pfizer for treating advanced kidney cancer, the agency said Friday.
The FDA announced the approval of Inlyta (axitinib) for patients with advanced kidney cancer, also known as renal cell carcinoma, who have not responded to another drug for the disease. The drug, a twice-daily pill, works by blocking certain proteins called kinases that are involved with tumor growth and disease progression.
"This is the seventh drug that has been approved for the treatment of metastatic or advanced kidney cell cancer since 2005," FDA Office of Hematology and Oncology Products director Richard Pazdur said. "Collectively, this unprecedented level of drug development within this time period has significantly altered the treatment paradigm of metastatic kidney cancer and offers patients multiple treatment options."
The other six drugs approved for advanced or metastatic kidney cancer since 2005 are Nexavar (sorafenib), made by Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals; Pfizer’s Sutent (sunitinib) and Torisel (temsirolimus); Novartis’ Afinitor (everolimus); Genentech’s Avastin (bevacizumab); and GlaxoSmithKline’s Votrient (pazopanib).
Armada Health Care inks software integration deal with Definitive Homecare
FLORHAM PARK, N.J. — Specialty pharmacy services company Armada Health Care and Definitive Homecare Solutions have signed a deal whereby Definitive Homecare’s CPR+ specialty pharmacy software will integrate with Armada’s service offerings, the two companies said.
The combination will give CPR+ customers access to Armada’s value-added services and the ability to integrate those services within their pharmacy workflow system. Armada members that don’t use CPR+ will have access to discount pricing for the software.
"CPR+ has long been the leader in the home infusion pharmacy industry, and that industry has high-touch patient care needs similar to those of specialty pharmacies," Armada CEO Larry Irene said. "Definitive Homecare has built on that background and tailored CPR+ for specialty pharmacy needs, providing tremendous value to pharmacies across the nation."
Watson, Mallinckrodt settle over generic painkiller
PARSIPPANY, N.J. — Watson Pharmaceuticals and Mallinckrodt have reached a settlement concerning a painkiller for which the former had sought Food and Drug Administration approval.
Watson announced that one of its subsidiaries had settled with Mallinckrodt over Watson’s generic version of Exalgo (hydromorphone hydrochloride) extended-release tablets. Mallinckrodt, a subsidiary of medical products maker Covidien, filed a patent-infringement suit against Watson in December 2010 in the U.S. District Court for the District of New Jersey after Watson sought FDA approval for a generic version of the drug in the 8-mg, 12-mg and 1- mg strengths.
Under the settlement, Watson gets a royalty-free license to patents related to Exalgo and can launch a generic version in November 2013. Other terms of the settlement were not disclosed. Watson said it was probably the first company to seek approval for a generic version, which would entitle it to 180 days of market exclusivity in which to be the sole competitor to Mallinckrodt’s product.