Aurobindo unit, China API maker dinged in latest round of FDA warning letters
After receiving a checkered regulatory scorecard in 2024, Aurobindo’s sterile injectables and oncology unit is back in the FDA’s crosshairs.
Eurofins expands operations to meet growing high-potency API demand
Canada-based Eurofins CDMO Alphora boosted its development and production to meet growing demand for both non-potent and high-potency APIs.
WuXi AppTec scores temporary win amid fight over DOD’s Chinese military company brand
Arguing that the Defense Department might have misread the evidence and inflicted harm on the company, a federal judge has thrown WuXi AppTec a lifeline as the research and manufacturing services juggernaut
ITM neuroendocrine tumor drug spurned by FDA over manufacturing qualms
The FDA has denied ITM Isotopes Technologies’ lead pipeline candidate for a rare group of tumors due to qualms over the drug’s manufacturing.
Bristol Myers Squibb lays out plan for $2.3B manufacturing facility in Houston
Bristol Myers Squibb has laid out plans for a $2.3 billion manufacturing facility in Houston, set for completion in 2030. The plant will cover 600,000 square feet and employ nearly 500 people.
Why Organizations Miss Emerging Product Risk: Understanding the engineering mechanisms that remain hidden long before complaint trends become visible
Medical device manufacturers collect vast amounts of post-market surveillance (PMS) data, yet important product risks are still frequently recognized only after complaint trends become statistically significant or corrective actions become unavoidable.1-5 The
Fresenius Kabi recalls mislabeled morphine lot that could cause overdose death
Fresenius Kabi voluntarily recalled one lot of morphine sulfate injection due to a labeling mix-up with prefilled syringes of dilaudid that could trigger an overdose resulting in severe respiratory distress or death.
Maja Pedersen named president, taking reins of Fujifilm’s CDMO as CEO role is retired
Fujifilm Biotechnologies passed the leadership reins to Maja Pedersen, adding president to her current role as COO while former Chief Executive Lars Petersen transitions to a strategic advisor position.
Beyond the Status Report: Using LLMs to Reveal the True State of SaMD Development
Project dashboards, requirements databases, sprint boards, and status reports attempt to answer this question. Yet in complex Software as a Medical Device development, these tools frequently describe the state of the project
Gerresheimer sheds pair of pharma packaging units in deal valued at €1.5B
Gerresheimer, a Germany-based packaging company that specializes in drug delivery systems and glass and plastic packaging, sold two of its units to the private equity group Apax Partners in a deal valued