A Johnson & Johnson exercise in creative problem solving has paid off for doctors and patients who rely on its ovarian cancer drug Doxil, availability of which has been uncertain for years. Its Janssen unit has accumulated a significant supply after assuming manufacturing at Boehringer Ingelheim plant that otherwise was closed down at the end of the year.
Translational medicine, which bridges the science of the emerging preclinical portfolio and the early development space where molecules are studied in humans for the first time, is an important if not essential element of successful pharmaceutical development.
Results are in from a showdown between chronic lymphocytic leukemia drugs Imbruvica, from Johnson & Johnson's Janssen unit, and GlaxoSmithKline's Arzerra. And as it turns out, it wasn't much of a contest.
Janssen, the biotech unit of Johnson & Johnson, is looking beyond just pharmaceuticals with its latest life sciences incubator, seeking out medical device and diagnostics startups to fill its planned lab space.
Johnson & Johnson's Janssen arm is planning to open another biotech incubator, this time setting its sights on South San Francisco in hopes of finding a few promising drug developers.
The FDA has now signed off on Janssen's process of manufacturing bulk Doxil at an Ohio facility. It is part of an "alternative manufacturing process" in which the company hands off fill and finish of the drug to another manufacturer.
Johnson & Johnson's Janssen, which has struggled to maintain ready supplies of its ovarian cancer treatment Doxil, has released a new lot of the popular drug. The injectable cancer med was produced through an "alternative manufacturing approach" in which the now-closed Ben Venue plant in Ohio made the bulk product and another manufacturer finished it off.
In defending the largest state-level decision ever won against Johnson & Johnson for its Risperdal marketing, the state of Arkansas said the New-Jersey based company didn't properly communicate the antipsychotic's risks and marketed it for off-label use. In its appeal, J&J said it didn't commit fraud or harm the state's Medicaid program. But Arkansas' Supreme Court had something entirely different to say when it overturned the $1.2 billion judgment Thursday.
Looks like the FDA has taken an advisory committee's Xarelto concerns to heart. Following up on an overwhelming "no" vote from last month, the agency Friday issued Johnson & Johnson's Janssen unit complete response letters regarding use of the anticoagulant in ACS patients.
Janssen and Ben Venue officials have assured a federal court that any operations Janssen initiates at Ben Venue's now-closed Ohio facility will comply with provisions of a consent decree that Ben Venue signed last year. The move came the same day that production officially ceased at the plant, which was the sole supplier of Doxil.