End-of-year downsizing is upon us. The Pfizer layoffs teased December 4 now have some shape – Bloomberg is reporting that the drug maker is set to lay off 20% of its primary-care sales force, or about 600 positions. Sandoz is also reducing its headcount by just over 100 positions, or 5% of its US workforce, according to Pharmalot, and Valeant's September Medicis acquisition now includes around 300 layoffs, reported the Phoenix Business Journal.
The FDA said it's adding a black box warning, the most serious kind, to the label of Vertex's hepatitis C drug Incivek concerning fatal cases of skin reactions. “Some patients died when they continued to receive Incivek, along with the drugs peginterferon alfa and ribavirin, after developing a worsening, or progressive rash and systemic symptoms,” the agency reported today. Rash and serious skin reactions were previously included in the warnings and precautions section of Incivek's label, but the fatalities came to light during post-marketing. In a statement, Vertex said that in Phase III trials, less than 1% of Incivek patients experienced a serious skin reaction and that all recovered. Launched in 2011, Incivek got off to a fast start, handily beating Merck's rival protease inhibitor Victrelis for dominance of the hep. C market. US sales were $797.8 million in 2011, according to Source Healthcare Analytics. But prescription growth for both has leveled, analysts say, as clinicians anticipate new interferon-free regimens, which could be approved as early as 2014.
Spencer Cox, an early leader of ACT UP's Treatment Action Group who schooled himself on the science behind the disease until his expertise was sought after by scientists, and who laid out the blueprints for the clinical trial protocol of the first protease inhibitors in 1995, died of AIDS-related causes yesterday in New York. He was 44. In more recent years, Cox was an eloquent writer who blogged for Poz, among other publications, and founded an organization to advocate treatment of the mental health issues facing a generation of gay men who'd lived through the grim early years of the AIDS epidemic.