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.
Boehringer Ingelheim is in the midst of closing down its troubled Ben Venue generic sterile injectables facility in Ohio after deciding it was not worth pouring more money into its rehabilitation. But given that there is growth in generic and contract injectable manufacturing, the German company hopes someone might want to take it off its hands.
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.
Boehringer Ingelheim has given up on its troubled sterile injectables plant in Bedford, OH, which may forever be remembered for the bucket of urine that FDA inspectors found in the production area. It is closing the plant, ceasing production by the end of the year and laying off 1,100 employees begining this month.
Johnson & Johnson's ($JNJ) Janssen unit, which has jumped through hoops to keep supplies of ovarian cancer drug Doxil in doctors' hands, is again being hamstrung by issues with its contract manufacturer, Ben Venue Laboratories.
Johnson & Johnson and the FDA sprang into action in 2011 when J&J's popular chemo drug Doxil became hard to get because of problems with the contract manufacturer. But it also figured out a process by which it could have it manufactured at one plant and finished at another.
In a push to ease a months-long shortage of Johnson & Johnson's cancer drug Doxil, the FDA on Monday approved the first generic version of the drug from India's Sun Pharma.
Anyone who follows pharma knows that FDA has called manufacturers on the carpet quite often over the past few years. One by one, some of the biggest names in the industry have had to ratchet back or suspend production to fix some scary-sounding manufacturing violations.
Johnson & Johnson ($JNJ) has been struggling with Doxil supplies for months. As one of the standard treatments for ovarian cancer, the drug has been sorely missed as supplies ran short. Now, the company is asking regulators to approve a new plan to boost supplies, at least in the short term.