Search results for " Europe"
Webcast
Bioprocessing Europe – 14-16 March 2023
This 3-day, 10 track meeting has quickly become a premier meeting in the European bioprocessing calendar and is regarded by many as “the fastest growing bioprocessing meeting in Europe” following reco…
Webcast
Bioprocess International Europe
Bioprocess International Europe
Vienna
April 9-12, 2024
Webcast
BPI Europe 2023 - May 9-12, 2023
Mark your calendar for Europe's leading bioprocessing event for accelerating next generation mAbs, novel modalities and ATMPs to commercial success.
Article
A Diverse Landscape of Patent Issues Seen in the US, UK, and the EU
the US?
Rooke (Start Codon): In Europe, there remains some uncertainty about the Unified Patent Court and Unitary Patent package established by the EU. A constitutional challenge in Germany has …
Article
EMA Collaborates with HTA Assessment Networks
Gaining access to Europe’s pharmaceutical markets has become a multi-stage operation. The licensing of a new drug is only a preliminary step in what can be a lengthy and complex procedure for some pha…
Article
Trends in BioPharma Approvals in 2013
A total of 16 approvals were recorded in Europe, while only six biopharmaceuticals came on the market in the US in that same period. This trend can partly be explained by Europe playing catch up in th…
Article
Biosimilars: Making the Switch Comes with Challenges
By Sean Milmo
The use of biosimilars continues to increase strongly in Europe, 10 years after the first biosimilar, a somatropin, was approved by the European Union (EU). With approximately 20 new…
Article
Maximum Output Starts with Optimized Upstream Processing
KBI Biopharma, for instance, is implementing a global expansion strategy that includes bringing online new clinical and commercial manufacturing facilities in the United States and Europe.Vibalogics i…
Article
Biopharma in 2015: A Year for Approvals and Innovations
One of the most groundbreaking approvals occurred in March, when the FDA approved the first biosimilar in the US (years after the first such approval in Europe), Sandoz’s Zarxio (filgrastim-sndz). The…
Article
GMP Challenges for Advanced Therapy Medicinal Products
By Sean Milmo
A consultation period on GMP guidelines (1) in the European Union, specifically for advanced therapy medicinal products (ATMPs), comprising gene- and cell-therapy products and tissue-…