Can oral insulin succeed where other alternative delivery methods have failed? Dan Stanton, from in-Pharmatechnologist.com assesses its chances.
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.
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).
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.
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.
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.
Biopharma companies are looking for more pre-fabrication of their facilities and to be able to expedite construction and meet tighter timelines, an expert told Outsourcing-Pharma.com.