The FDA told Novo Nordisk it's going to have to cool its heels a little longer for a decision on its long-acting insulin degludec/aspart. An advisory panel was set to review the drug in June, then pushed it off until October, and the FDA just told told Novo the drug review has been shuffled a third time: a panel is set to give the drug a once-over in November. Novo's website says degludec/aspart helps maintain glucose levels over sustained periods of time, keeping them constant for between eight and 40 hours.
Johnson & Johnson is slashing 200 jobs at a Tylenol plant in Puerto Rico, reported the Associated Press. The news outlet said it cuts are part of a modernization push --- the FDA found deficiencies at the location, and the cuts will shrink the site's headcount by about 25%. This is one of the three McNeil plants that are covered by a consent decree, as the AP notes.
The FDA has issued an untitled letter to Bristol-Myers Squibb over a sales aid for Ixempra, saying the promotional material is misleading due to unsubstantiated efficacy claims and broadening of the indication. The drug carries a boxed warning for patients with hepatic impairment due to increased risk of toxicity and neutropenia-related death, along with a “Warnings and Precautions” section flagging other risks including peripheral neuropathy.