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. [...]

Jim “Buddy” Caldwell, the state’s new attorney general, withdrew the multi-million-dollar antitrust lawsuit against the biotech, which his predecessor filed on his final day in office last January, the Associated Press reports.
Last Friday, however, a notice filed in US District Court said the new AG dismissed the case “without prejudice.” Allen Usry, a private lawyer [...]

Let’s take one problem at a time. First, there are fresh concerns over potentially troubling safety data from a late-stage study of the biotech’s drug for postmenopausal osteoporosis, known as denosumab. Wall Street is worried because results show the med increased bone density in both early and late stage postmenopausal women, but patients had a [...]

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 House Energy and Commerce Committee wants the biotech and the health care giant to turn over documents concerning promotion of their anemia drugs, which have been linked to increased risk of death at high doses. In particular, the documents include DTC ads for Johnson & Johnson’s Procrit, and Amgen’s contracts with oncologists, because the [...]

Maybe. That’s what we hear from sources familiar with the biotech, which is enduring all manner of difficulties for more than a year. An FDA panel urged tighter restrictions for its Aranesp flagship med after studies found increased risks of cardiovascular disease, tumor growth and death. Congress is investigating the marketing and safety of Aranesp [...]

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 [...]