Friday, November 30, 2018 Daily Archives

Preparing for and Managing Regulatory Inspections

This webcast features: Ray Marzouk, Vice President of Quality at Avid Bioservices Inc. Nothing gets your heart racing faster than receiving a call from your lobby notifying you that a regulatory authority has arrived to perform an inspection. However, with proper preparation and established inspection management protocols in place, navigating a regulatory inspection doesn’t have to be a scary proposition. As a CDMO manufacturing commercial products since 2005, Avid Bioservices Inc. has successfully hosted several regulatory GMP inspections and PAIs…

Bayer takes $680m hit on German factor VIII plant

Bayer is abandoning a facility in Germany in plans to concentrate all hemophilia factor VIII protein production at its plant in Berkeley, California. The decision comes as part of a full business restructure, which will axe 12,000 jobs. In 2014, Bayer invested more than €500 million ($568 million) into its recombinant factor VIII (rFVIII) hemophilia manufacturing network, including establishing additional capacity at a plant in Wuppertal, Germany. But as part of a significant business shake-up announced yesterday, the German drugmaker…

Teva settle with Roche to launch first Rituxan biosimilar in US

Truxima becomes the 15th biosimilar, and the first version of Rituxan (rituximab), to be approved in the US. A settlement agreement with Roche will allow Teva to market the product but the launch date has not been revealed. The US Food and Drug Administration (FDA) gave the thumbs up to Truxima this week, making it the first biosimilar version of Roche/Genentech’s Rituxan to be approved in the US. The product is manufactured by South Korean firm Celltrion but will be…