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Porcine trypsin (PTy), a starting material used in biologic drugs, should be tested just after it is produced to ensure material from a single infected pig doesn’t enter production batches, EU regulators say. Read More
Compounding pharmacies have flooded the FDA with hundreds of comments seeking to protect access to bulk drug substances they use to make products. Read More
The FDA and European Medicines Agency (EMA) are extending for two years a pilot program for joint reviews of quality-by-design (QbD) applications, saying the program has helped both agencies develop guidance in this area. Read More
Sagent Pharmaceuticals is the latest drugmaker to recall products with leaky containers, notifying healthcare providers that two lots of its Zoledronic Acid Injection product may not be sterile after finding that four premix bags had been compromised. Read More
Endo Pharmaceuticals has overcome three complete response letters for its low testosterone treatment Aveed, winning FDA approval for the injectable with a robust risk mitigation program. Read More
After six years of uncertainty, the FDA has lifted a clinical hold on trials of Oxygen Biotherapeutics’ Oxycyte intravenous emulsion, reviving hope for the drugmaker’s traumatic brain injury treatment. Read More
Beginning on June 16, whenever a drugmaker receives approval for a new drug by an EU member state, it will have 15 calendar days to report the approval to the EMA’s new centralized electronic registry. Read More
Baxter’s struggles with particulates continue, as the drugmaker Wednesday recalled a single lot of dialysis solution contaminated with mold after reports of adverse events. Read More
The FDA has rejected a diabetes drug co-developed by Boehringer Ingelheim and Eli Lilly due to unresolved quality issues at one of Boehringer’s plants. Read More