FDA approves a biosimilar and loses a commissioner in March.
Bausch’s second generation Type 529 is a semi-automatic IV bag filling and closing machine designed for aseptic packaging of infusions, parenteral drugs, and other fluids with a fully integrated automatic closing system to eliminate possible contamination.
Care needs to be made to match the method of limit determination to the analytical method.
Cornell Stamoran, Catalent Pharma Solutions vice-president, is elected to the board of trustees of the Pharma & Biopharma Outsourcing Association.
Rentschler Biotechnologie launches 2000-L single-use bioreactor and announces additional expansion.
As an affiliate member, TraceLink brings serialization expertise to the Pharma & Biopharma Outsourcing Association.
Big service providers get bigger faster thanks to Big Pharma.
GSK notifies CDC and FDA that it is recalling the remaining doses of its 2014–2015 flu vaccine, Flulaval Quadrivalent Thimerosal-free Pre-Filled Syringes, due to decreased potency.
The European Medicines Agency releases findings from marketing authorization application analysis.
FDA extends ANDA rule comment period to June 8, 2015 after requests for more time.