Bayer HealthCare submits approval application for colorectal cancer drug
SOUTH SAN FRANCISCO, Calif. — Two drug makers are looking to win approval for an experimental drug in patients with colorectal cancer that has spread to other parts of the body.
Onyx Pharmaceuticals announced that Bayer HealthCare had submitted a regulatory approval application to the Food and Drug Administration for regorafenib in patients with metastatic colorectal cancer.
The drug is a Bayer compound, and Onyx will receive a royalty based on global net sales of the drug for cancer. The regulatory submission was based on a 760-patient, phase-3 study conducted in North America, Europe, China, Japan and Australia, results of which were presented in January at a symposium of the American Society of Clinical Oncology and will be presented at ASCO’s annual meeting in Chicago next month.
FDA panel declines to recommend new approval for J&J anticlotting drug
RARITAN, N.J. — A Food and Drug Administration expert panel has recommended against expanding the approval of a Johnson & Johnson drug, the company said.
J&J subsidiary Janssen Research & Development said the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted against recommending approval of Xarelto (rivaroxaban) combined with antiplatelet drugs to reduce the risk of secondary cardiovascular events in patients with acute coronary syndrome.
The FDA is not required to follow the recommendations of advisory committees, but usually does. Xarelto already is approved for reducing the risk of blood clots in patients who have had knee or hip replacement surgery and for reducing the risk of strokes and other blood clots in certain people with atrial fibrillation.
Endo parent company changes name to Endo Health Solutions Inc.
CHADDS FORD, Pa. — The parent company of Endo Pharmaceuticals has changed its name, the company said.
Shareholders of Endo Pharmaceutical Holdings voted at the company’s annual shareholder meeting Wednesday to change the company’s name to Endo Health Solutions. The company said the name change would more accurately reflect its new business model, which aggregates four operating businesses into one enterprise.
"This important decision by our shareholders marks a milestone in our company’s history and reinforces our position in the market as a leading provider of health solutions, merging healthcare information and a broader array of innovative treatment options that can ultimately lead to improved health outcomes for patients," Endo president and CEO Dave Holveck said.
The company’s new business model will include four segments: medical device developer AMS; branded drug division Endo Pharmaceuticals; medical services, software, laboratory and medical records technology provider HealthTronics; and generic drug maker Qualitest.