December 6, 2007 |
Amgen Inc. received European Commission approval to market its drug Vectibix for use by colon cancer patients after standard chemotherapy procedures fail. The clearance was based on a positive risk/benefit ratio for seriously ill patients who have few treatment options, the Thousand Oaks-based company said.
December 1, 2007 |
Amgen Inc. said Friday that interim results from an independent study involving breast cancer patients found its anemia drug Aranesp did not enhance the effect of chemotherapy before surgery. Amgen shares, which closed at $55.25, down 21 cents, fell 4% to $53 in extended trading as the company also reported preliminary follow-up data showing more deaths and reports of tumor growth among patients who received Aranesp than among those in the control group.
November 13, 2007 |
Amgen Inc. said it received two federal subpoenas in the last month seeking documents about its products. One subpoena came from the U.S. attorney's office for the Eastern District of New York on Oct. 25, and the other from the U.S. attorney's office for the Western District of Washington on Nov. 1, the Thousand Oaks-based company disclosed in a regulatory filing Friday. The filing doesn't say which products are involved.
November 9, 2007 |
Warning labels on anemia drugs made by Amgen Inc. and Johnson & Johnson have been strengthened to reflect concerns that they boost the risk of heart attacks, stroke and death, regulators said Thursday. Millions of cancer and kidney disease patients take the drugs, known as erythropoiesis-stimulating agents. EPO drugs include Amgen's biggest drug, Aranesp, and an older version, Epogen, and J&J's Procrit.
November 8, 2007 |
Early results from an ongoing study showed that people with newly diagnosed rheumatoid arthritis were more likely to reach clinical remission with Thousand Oaks-based Amgen Inc.'s Enbrel plus methotrexate than with methotrexate alone. Results from the first year of a two-year study of 542 patients showed that 50% of the patients who received Enbrel plus methotrexate were in remission. That compared with 28% of patients receiving methotrexate alone.
October 25, 2007 |
Biotech giant Amgen Inc. -- battered by regulators, stung by falling sales of its top drugs and hit by layoffs this summer -- began Wednesday to spell out the price it has paid. The Thousand Oaks-based firm said its profit decreased 82% compared with a year earlier. The company said it wrote off $850 million in costs to shutter manufacturing plants and reduce its workforce by 2,600 employees.
October 24, 2007 |
In a decisive victory, biotech giant Amgen Inc. won a jury verdict Tuesday involving a patent case that could have allowed a competitor to muscle in on its lucrative anemia drug franchise. The Thousand Oaks-based biotech's shares rose $1.58, or 2.8%, to $57.70 on the news. Swiss drug maker Roche Holding Ltd. had planned to introduce an anemia drug under the brand name Mircera as early as this year. In an uncommon legal strategy, Roche sought to show that Amgen patents were invalid.
October 23, 2007 |
The largest group of U.S. cancer doctors said Monday that Medicare has gone too far in restricting the use of anemia drugs made by Amgen Inc. and Johnson & Johnson and released its own guidelines. The doctors' recommendations add new warnings about heart risks while saying patients can safely use higher doses than Medicare allows.
October 19, 2007 |
Thousand Oaks biotech giant Amgen's summer doldrums are stretching into the fall. This month Aetna Inc., one of the nation's largest insurers, quietly changed its reimbursement guidelines for the company's anemia drugs, echoing Medicare's new tighter reimbursement policy for the medicines. Aetna is the largest private insurer to do so, and analysts expect others to follow soon.
October 17, 2007 |
Amgen Inc. and Johnson & Johnson were set back in efforts to overturn Medicare limits on use of the firms' anemia drugs when U.S. drug regulators found the restrictions appropriate. Payment rules set by Medicare, the U.S. healthcare program for the elderly and disabled, are "generally consistent" with prescribing information for use of the drugs in cancer patients, the Food and Drug Administration said in a letter released Tuesday by Reps. Pete Stark (D-Fremont) and Henry A.