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.
While the FDA has yet to give its final sign-off to this creative work-around, it has permitted the Johnson & Johnson subsidiary to release a lot at a time, the latest last week.
Boehringer Ingelheim's Ben Venue Laboratories plant in Bedford, OH, continues to struggle to make sterile products more than a year after it came under heightened FDA review for serious manufacturing problems.
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.
Sun Pharmaceutical Industries shares fell on worries that the Indian drugmaker will lose a contract to sell its version of the cancer drug Doxil in the U.S., after Johnson & Johnson ( $JNJ ) said...
After a voluntary shutdown of facilities last November, Ben Venue Laboratories has revived limited manufacturing at its Bedford, OH, operation as the contract manufacturing unit of the German drugmaker Boehringer Ingelheim resolves remaining issues there.
Generic competition hit a few of Johnson & Johnson's ($JNJ) big sellers during the third quarter, but other products--including its newest ones--more than filled the breach. The company's pharma division turned in a 7% increase in sales, to $6.4 billion, even after a 4.3 percentage-point currency hit.
Johnson & Johnson has come through with more of its cancer drug Doxil to fill orders from biotechs that need the drug for their clinical trials, after months of rationing the drug because of a key supplier's manufacturing problems.
For the second quarter in a row, Johnson & Johnson posted a downward tick in revenues, hobbled by currency losses. Asset writedowns, legal-settlement set-asides, and acquisition costs dug into earnings.