Drug shortages

All doses of Eli Lilly’s type 2 diabetes medication Mounjaro and weight-loss drug Zepbound are now available, according to an update on Friday to the FDA’s drug shortage database.

The regulator on Friday warned healthcare providers and patients about adverse events linked with dosing errors from compounded versions of Novo Nordisk’s weight-loss and diabetes drugs.

AbbVie and Merck/Daiichi Sankyo were hit this week with Complete Response Letters from the FDA, which rejected their respective drugs due to manufacturing issues.

Nearly all doses of Eli Lilly’s highly popular weight-loss drug Zepbound and type 2 diabetes medication Mounjaro will have limited availability through the second quarter of 2024, according to the regulator.

The American Society of Health-System Pharmacists has released statistics showing the number of active and ongoing U.S. drug shortages has reached 323, the highest number since it began tracking the data.

The four highest doses of Eli Lilly’s blockbuster diabetes treatment Mounjaro will be in short supply through the rest of the month due to strong demand, according to the regulator.

Amid the dual crises of worsening medicine quality and growing drug shortages, the FDA plans to increase inspections of Indian manufacturing facilities this year, Reuters reported Tuesday.

This week Lori, Greg and Tyler discuss the ⁠Accelerated Approval of Amtagvi⁠, the first one-time cell therapy for solid tumors and the first TIL therapy; the ⁠FTC and HHS probe⁠ into generic drug shortages and some recent ADC-focused raises from ⁠ProfoundBio⁠ and ⁠Firefly Bio⁠.

The Federal Trade Commission and Department of Health and Human Services on Wednesday said they are investigating group purchasing organizations and drug wholesalers’ possible involvement.

This week, Greg, Heather and Tyler discuss reaction to ⁠Novo Nordisk’s purchase of Catalent⁠ and speculate on what that means for existing manufacturing contracts, customers and consequences with ⁠regulators⁠.