Company news: Novo; J&J's McNeil; BMS

Share this article:
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.



Share this article:
close

Next Article in Business Briefs

Email Newsletters

More in Business Briefs

Researchers hit links for charity

The PMR Charities Golf Classic teed up more than $20,000 for St. Jude Children's Research Hospital.

FDA to review Neupogen biosimilar

Novartis subsidiary Sandoz announced Thursday that the FDA has agreed to review its filgrastim biosimilar which is already approved in 40 countries.

FDA approves a new painkiller

Targiniq ER combines the prescription opioid oxycodone and naloxone, which is often used to treat overdoses.