Scrambling to generate needed revenue, Roche has filed an appeal of a preliminary court injunction that bars US sales of its Mircera anemia med. The move comes as US District Court Judge William Young considers whether to require Amgen to license its patents to its Aranesp and Epogen drugs in return for a licensing fee. [...]

By and large, Amgen shareholders are not a happy bunch. The biotech’s stock is down about one-third in the past year, thanks to various FDA warnings and health risks associated with its Aranesp and Epogen anemia meds, not to mention reduced Medicare reimbursement. For awhile, ceo Kevin Sharer appeared in denial, until he began slashing [...]

It took Kevin Sharer nearly a year to admit the biotech was having a crisis, and that’s probably because he finally realized he wouldn’t get as much money as he had in the past. His 2007 compensation was down nearly 29 percent - to $13.2 million - from $18.6 million the year before, according to [...]

The federal judge overseeing the patent battle between Amgen and Roche has ordered that an expert be appointed to recommend how to compare the dosing and prices of their anemia drugs, Reuters reports.
Last October, a federal court jury in Boston found that patents on Amgen’s anemia drugs were valid and that Roche’s Mircera, which has [...]

After being called the equivalent of a snake oil salesman, Roche execs accepted terms imposed by a federal judge in order to begin selling their new Mircera anemia medication. The tentative arrangement follows Roche’s defeat last October in a Boston courtroom, where the drugmaker was found to have violated patents on Amgen’s best-selling Aranesp and [...]

A closely watched FDA panel meeting ends with not-such-great news for Amgen and Johnson & Johnson. The drugmakers can continue marketing their anemia meds for cancer patients, but the current use should be restricted over concerns the drugs can increase the risk of tumor growth and death. However, the panel decided against completely restricting use [...]

How’s this for imagery? For more than two decades as an oncologist, Richard Pazdur frequently delivered bad news to patients. Once, a dying man grabbed his coat and begged him to try even more chemotherapy. But the doc says he declined, because he believed further treatment wouldn’t help. The patient died less than an hour [...]

Big drugmakers are ponying up over the AWP, or average wholesale price scandal, according to a statement by attorneys who filed the case. For those unfamiliar, the stated AWP is used to set the price paid by consumers making Medicare Part B co-payments, as well as Medicare, insurers and other third-party payors that shell out [...]

Amgen expanded the Black Box warnings about the risks of death and tumor growth with its blockbuster anemia drugs, Aranesp and Epogen. The warnings come less than a week before an FDA advisory committee meets to discuss the risks associated with these meds, a group known as ESAa and which also includes Johnson & Johnson’s [...]

An FDA advisory committee will meet next Thursday to review the latest evidence of risk for cancer patients who are treated with widely used anemia meds - Amgen’s Aranesp and Johnson & Johnson’s Procrit. The same panel met last May, but since then, new data was given the FDA from several studies showing increased risks [...]