The presence of toxic nitrosamine impurities in drug substances and drug products has become a significant focus for the pharmaceutical industry following their identification above permitted limits in common drug products prescribed for type 2 diabetes, high blood pressure and heartburn. To learn more about the situation, we interviewed David Elder – CMC consultant –…

The FDA issued a notice today announcing that the recall of the Baxter Abacus software is Class I, the most serious kind. Baxter designed its Abacus order entry and calculation software to perform calculations for compounding liquid doses of medications. When connected to a compounded that mixes doses according to the calculation, the software can…

Lab automation specialist Beckman Coulter Life Sciences has appointed Cardinal Health veteran Suzanne Foster as president. Foster served as Cardinal Health’s President Health-at-Home subsidiary from January 2020 to March 2022. She has more than 25 years of experience in the healthcare industry, and also sits on the boards of several companies. Foster has also served…

Cardinal Health directors’ insurers will pay the company $124 million to settle a stockholder derivative action related to the opioid crisis. The company (NYSE: CAH) on July 22 issued a court-authorized notice to alert investors to a settlement hearing to be held on Oct. 4 in U.S. District Court in Southern Ohio. If the settlement…

Novartis announced recently that it has restarted radioligand therapy (RLT) production at two different sites. Basel, Switzerland-based Novartis on June 30 said that it restarted production in “early June” at its Ivrea, Italy, and Millburn, New Jersey, sites, according to a news release. The company had halted production in May due to what it cited…

GSK plc (LSE/NYSE: GSK) has demerged from its consumer healthcare division to create the publicly-traded company Haleon Group. Haleon is now one of the world’s largest consumer healthcare companies, while GSK will focus on growing its prescription drug and vaccine businesses.  The company announced the “Haleon” name in February.   In hindsight, GSK would have fared…

FDA has sent warning letters to four companies for illegally marketing honey-based products with unlisted active drug ingredients found in the erectile dysfunction drugs Cialis (tadalafil) and Viagra (sildenafil). The agency said it confirmed the presence of contaminants in the products through laboratory testing. The agency sent the warning letters to the following companies: Thirstyrun…

Liquid-handling instrument firm Mettler-Toledo Rainin, LLC has expanded its presence in the Interchange Business Park in Vacaville, California, a biomanufacturing hub 35 miles southeast of Sacramento. “We are excited to expand our manufacturing operations in Vacaville,” said Werner Maas, Rainin general manager, in a news release. “The high cost and scarcity of real estate in the central…

Automation company Comau has introduced the ruggedized Racer-5 Sensitive Environments (Racer-5 SE) robot for use in the pharmaceutical, health and beauty, food and beverage and electronics industries. The robot is designed to support the demands of cleanrooms and other sensitive environments with significant controls against contamination. The Racer-5 can be used in grade 6 ISO…

LabOps intelligence platform developer Elemental Machines is vying to boost enrollment in the Freezer Challenge, an annual competition intended to reduce the environmental impact of lab refrigerators, freezers and cold rooms.  Organized by the nonprofit My Green Lab and the International Institute for Sustainable Laboratories (I2SL), the Freezer Challenge attracts thousands of scientists internationally with a…