The FDA has issued Biocon and partner Mylan a complete response letter for their biosimilar of chemotherapy drug Neulasta tied to manufacturing.
Budding CDMO Avara Pharmaceutical Services has bought a solid dose facility in France from AstraZeneca, its third plant acquisition in three months.
Novo has filed a citizen petition saying Victoza’s manufacturing is so complex that equivalence of generics can't be certain without clinical trials.
Johnson & Johnson will invest $350 million to expand a biologics plant in Ireland where it makes the APIs for a number of its top sellers.
AbbVie began the next phase of its Singapore manufacturing expansion with a new biologics unit that complements the plant's existing API production.
Swiss CDMO Lonza said it has purchased a clinical-stage manufacturing site in Hayward, California, from Shire.
Dasan E&T was handed an FDA warning letter based on an inspection earlier this year that found numerous testing and manufacturing issues at its plant.
French police searched a Merck KGaA's French HQ as consumer complaints have piled up over a formulation change to Levothyrox.
Pharma giant Merck said it will spend $41 million at its Merck Serono facility in Bari, Italy, to build a new injectables production line.
The FDA is concerned that disruption of drug manufacturing in Puerto Rico could lead to critical shortages of some medicines.