Manufacturing
The recurrence of violations at multiple sites led the FDA to conclude that Baxter management must improve its oversight and control of manufacturing.
The European Commission approved Germany’s financial support after assessing the risks of Sanofi stopping insulin API production at the Frankfurt campus.
Inconsistent reporting at a Pennsylvania site affected microbiological analyses of components and drug products that analytical testing service provider Eurofins ran for customers.
In this episode of Denatured, presented by Cytiva, Jennifer Smith-Parker speaks to Nicolas Pivet, VP & GM, Manufacturing & Digital Solutions at Cytiva. In this episode, we explore how biopharma’s real bottleneck isn’t too little data—it’s too little confidence in the decisions that drive development, manufacturing and commercialization.
Starting next year, GSK plans to demolish existing buildings and construct new facilities to support clinical and commercial supply. The investment will create more than 300 new jobs over the next five years, Pennsylvania state officials said.
CDMO-sponsor relationships have shifted from transactional outsourcing to strategic collaboration built on shared risk, regulatory fluency and technical insight. As rising compliance pressure and geopolitical volatility reshape manufacturing, partners like Rose BioSolutions argue that true value now comes from challenging assumptions, anticipating hurdles and protecting programs before problems surface.
With an internal non-opioid program nearing approval, Viatris is picking up Pacira BioSciences for a broader pain portfolio and the associated commercial infrastructure.
With the patent court siding with Halozyme, Merck faces restrictions on a product that won approval in Europe last year.
The investment will equip Bayer to make oncology, cardiovascular and renal care ingredients and drugs.
Despite the regulatory delay, Novo is still expecting a 2027 launch for its hemophilia A drug denecimig.
PRESS RELEASES