Doxercalciferol now available from Roxane Labs
COLUMBUS, Ohio — Roxane Labs on Tuesday announced the introduction of doxercalciferol capsules, available in strengths of 0.5-mcg, 1-mcg, and 2.5-mcg in 50-count bottles for immediate shipment to wholesalers and pharmacies across the nation.
Doxercalciferol is used to lower elevated parathyroid hormone levels in patients who undergo kidney dialysis. Roxane Labs’ doxercalciferol capsules is AB Rated in the Food and Drug Administration Orange Book to Hectorol (doxercalciferol) capsules, 0.5-mcg, 1-mcg, and 2.5-mcg.
Annual sales of doxercalciferol capsules are approximately $48.7 million.
Novartis acquires CoStim Pharmaceuticals
BASEL, Switzerland — Novartis on Monday announced that it is broadening its cancer immunotherapy research program with the acquisition of CoStim Pharmaceuticals, a Cambridge, Mass.-based, privately held biotechnology company focused on harnessing the immune system to eliminate immune-blocking signals from cancer.
Increasing evidence points to the role of the immune system in controlling cancer and to opportunities for creating effective oncology therapies for cancer patients by stimulating a targeted immune response. Already leading in cancer immunotherapy, with investigative chimeric antigen receptor technology being developed in collaboration with the University of Pennsylvania, with this acquisition Novartis has added late discovery stage immunotherapy programs directed to several targets, including PD-1. These medicines could benefit patients by circumventing cancer’s ability to develop resistance against current single drugs.
"Therapy for many types of cancers are expected to increasingly rely upon rational combinations of agents," stated Mark Fishman, president of the Novartis Institutes for BioMedical Research. "Immunotherapy agents provide additional arrows in our quiver for such combinations. They complement our extensive portfolio of drugs that hit genetically defined cancer-causing pathways, and also may be relevant to expansion of CAR therapies."
Financial terms were not disclosed.
Vimizim receives FDA approval
SILVER SPRING, Md. — The Food and Drug Administration has approved Vimizim (elosulfase alfa), the first FDA-approved treatment for Mucopolysaccharidosis Type IVA (Morquio A syndrome), which is a rare disease caused by a deficiency in N-acetylgalactosamine-6-sulfate sulfatase (GALNS).
Vimizim is intended to replace the missing GALNS enzyme involved in an important metabolic pathway. The absence of the enzyme leads to problems with bone development, growth and mobility. There are approximately 800 patients with Morquio A syndrome in the United States. Vimizim also is the first drug to receive the Rare Pediatric Disease Priority Review Voucher, which seeks to encourage development of new drugs and biologics that prevent and treat rare pediatric diseases.
“This approval and rare pediatric disease priority review voucher underscores the agency’s commitment to making treatments available to patients with rare diseases,” said Andrew E. Mulberg, M.D., deputy director of the Division of Gastroenterology and Inborn Errors Products in the FDA’s Center for Drug Evaluation and Research. “Prior to today’s approval, patients with this rare disease have had no approved drug treatment options.”
Vimizim is marketed by BioMarin Pharmaceutical.