Genentech seeks regulatory approval for vemurafenib
SOUTH SAN FRANCISCO, Calif. — Genentech is seeking approval for a new drug to treat skin cancer, the company said Wednesday.
Genentech, part of Swiss drug maker Roche, announced that it had submitted a regulatory approval application to the Food and Drug Administration for RG7204 (vemurafenib), a treatment for BRAF V600 mutation-positive melanoma that has spread to other parts of the body, also known as metastasis. Melanoma is the deadliest and most aggressive form of skin cancer. The drug is designed to inhibit a mutated form of the BRAF protein found in about half of melanoma cases.
“We have worked swiftly to advance the vemurafenib development program, knowing that patients with metastatic melanoma have a poor prognosis and limited options,” Genentech chief medical officer and head of global product development Hal Barron said. “The regulatory submissions of vemurafenib and the companion diagnostic to identify people with the type of melanoma specifically targeted by this medicine are exciting steps toward our goal of delivering a personalized therapy for this disease.”
Activant inks deal with RDC
LIVERMORE, Calif. — An independent wholesale drug cooperative will promote Activant Solutions’ point-of-sale software system to its members, Activant said.
The Rochester Drug Cooperative, which services more than 950 retail pharmacies, long-term care pharmacies and healthcare stores in the Northeast and Ohio, will recommend the Activant Eagle system its members. Activant Eagle allows independent pharmacies to manage all parts of their operation, including point-of-sale, inventory management, financials, purchasing, payroll and marketing.
“As margins on pharmaceutical sales continue to shrink, more and more independent pharmacies are focusing on front-of-store performance,” Activant EVP Paul Salsgiver said. “Activant is very pleased to work with [RDC] to help their members become more efficient and competitive retailers.”
APhA releases REMS white paper
WASHINGTON — The American Pharmacists Association has published its white paper on risk evaluation and mitigation strategies, the group said.
Published in the May/June 2011 issue of the Journal of the American Pharmacists Association, the “APhA 2011 REMS White Paper: Summary of the REMS stakeholder meeting on improving program design and implementation” focuses on designing a system that maximizes patient safety while minimizing burdens on the healthcare system. The paper was the product of a meeting the APhA sponsored in October that brought together 34 stakeholders representing organizations for pharmacists, pharmacies, physician assistants, nurses and nurse practitioners, drug makers and others, as well as observers from the Food and Drug Administration. The discussion focused on four themes: effective provider interventions, REMS standardization and communication models, using existing technology in the provider workspace for REMS implementation and ensuring a sustainable business model for REMS-related provider activities.
Recommendations included standardizing REMS programs, components and processes; utilizing effective provider interventions, such as personal consultations with patients; leveraging existing technology solutions in medical and pharmacy practice settings; establishing a central repository or clearinghouse for all REMS-related information; improving communication strategies and awareness of REMS programs and implementation requirements; and establishing compensation models to ensure providers have staff and resources to implement REMS programs.
The white paper is available at Pharmacist.com/REMS2011.