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.
Janssen Pharmaceuticals, which has struggled to maintain supplies of its cancer drug Doxil since supplier Ben Venue Laboratories ran into FDA issues, may have landed on a way to help keep supplies available. The Johnson & Johnson unit has an agreement to lease part of Ben Venue's Bedford, OH, plant and take on manufacturing itself.
No one ever climbed the industry ladder without getting some help along the way. And for women, including many of the accomplished top performers in this group, that can be especially important....
A Philadelphia jury didn't buy Johnson & Johnson's argument that it had properly warned doctors and patients about the birth-defect risks associated with its seizure drug Topamax. The panel ordered J&J's Janssen unit to pay $11 million to Haley Powell, whose son was born with a cleft palate.
The saga of the shortage of ovarian cancer drug Doxil has hit a new turning point, and not for the better. Johnson & Johnson has indicated it will have no supplies of the popular drug until at least the end of next year because its sole supplier is permanently closing the plant that makes it and it will be unable to get new suppliers approved for another 12 months or more.
Johnson & Johnson, which has been battling a host of problems tied to its consumer healthcare operations, is back in the baby powder business in Mumbai, India. A plant that was ordered closed by authorities there three months ago has been allowed to resume production.
Johnson & Johnson ($JNJ) aims to advance antiviral compounds against the rising threat of dengue infection by teaming with Belgian academics whose backing from the Wellcome Trust has aided the discovery of potential drugs against all four strains of the mosquito-borne illness.
The closely watched cancer treatment ibrutinib, winner of three "breakthrough" designations from the FDA, is now ready for the agency's review.
The agency is providing a priority review for the therapy (TMC435) in combination with interferon and ribavirin, possibly speeding its way to the market.