Three Canadian drug companies have issued a voluntary recall following potential contamination during manufacturing of an API by their Chinese CMO.
GlaxoSmithKline (GSK) says some manufacturing from the shuttering of an Australian packaging site will be picked up by Aspen and local third-party contractors.
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.
Supplementing prospective randomized, double-blinded clinical trial data with real-world patient data holds “an enormous amount of potential” for CROs and trial sponsors, according to an expert.
ADC Biotechnology says demand for antibody drug conjugates (ADC) services has skyrocketed as it receives a second financial boost to development in four months.
Disposable bioreactors could be the centerpiece of a project to develop and harvest large quantities of cells that eventually will be used in bioartificial livers for patients with severe liver failure.
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.
Following a busy few months, Capsugel spoke about the formation of its Dosage Form Solutions Unit, its technology and the integration of Encap at this year's Interphex in New York.
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.
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.