23-May-2013 - Sandoz has recalled two lots of an injectable drug after vials were discovered to contain foreign matter, though is unsure of the cause for now.
News in brief
23-May-2013 - Pfizer and other EU industry and academic groups are calling on the European Commission to revise its plans for authorizing and regulating ATMPs (advanced therapy medical products).
22-May-2013 - Three Canadian drug companies have issued a voluntary recall following potential contamination during manufacturing of an API by their Chinese CMO.
22-May-2013 - Boehringer-Ingelheim’s German API and pharmaceutical manufacturing facility was cited by the FDA for two API and two drug cGMP violations, as well as failing to respond with sufficient corrective actions after the first Form 483.
22-May-2013 - Faced with manufacturing quality questions that caused the FDA to reject its potential Parkinson’s disease treatment, Impax Laboratories has hired a committee of specialists to oversee quality improvements at its California facility.
21-May-2013 - The EMA (European Medicines Agency) has released draft guidelines on biosimilars allowing non-EEA comparators to be used in limited circumstances.
21-May-2013 - Lonza says it is raising awareness of the role horseshoe crabs play in QC endotoxin detection tests, and its PyroGene Assay can provide a sustainable alternative.
21-May-2013 - US House Democrats have re-introduced a bill that would expand trial data reported by companies to clinicaltrials.gov, but a recent EU court decision shows what kind of resistance should be expected.
Regulatory & Safety: Featured news
In-Pharmatechnologist.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals, including news from Bayer, Valeant and Eisai.
In-Pharmatechnologist.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals, including news from Mylan, Sigma-Tau and Immunocore.