The European CDMO Model, Powering Biologics Innovation
Europe continues to play a pivotal role in the global biologics landscape, combining scientific excellence, regulatory maturity and a strong industrial foundation.
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About Maren Kühr
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Entries by Maren Kühr
Mitigating regulatory risk with holistic CMC strategies
As advanced therapeutic medicinal products (ATMPs) and other next-generation biologics move toward approval, Chemistry, Manufacturing and Controls (CMC) continues to be the most frequent source of regulatory concern. This article highlights recurring CMC barriers and best practices to mitigate approval delays or refusals.
Leadership change
Swiss biotech company Anaveon has appointed a new Chief Executive Officer. As the company announced in March, experienced biopharma executive Thaminda Ramanayake will take over the leadership of the Basel-based firm.
Is the Unified Patent Court affordable for small biotechs?
The Unified Patent Court and the unitary patent were established to make patent litigation in Europe easier, faster and more affordable. It has been particularly emphasized that the new system was designed to enable small and medium-sized enterprises to enforce their rights more effectively and rapidly. The reality now suggests differently. Litigation in Europe has become quite fragmented, more complex and more expensive than ever – a nice playground for deep pockets.
New CFO with Novartis experience
In March, Mukul Mehta took over as the new Chief Financial Officer at Basel-based Biotech and Pharma Company Novartis. At the same time, he became a member of the Executive Committee.
New CCO strengthens global business strategy
Bristol-based cell and gene therapy CDMO eXmoor Pharma appointed Manuel Balbuena as Chief Commercial Officer at the beginning of March.
Return as new Chief Financial Officer
Jurgen Berendsen has returned to Symeres (Nijmegen, NL) as Chief Financial Officer. His appointment took place at the beginning of this year.
New COO takes over
Cambridge-based techbio company Qureight Ltd has appointed Rebecca Simmons as its new Chief Operating Officer in January.
PL BioScience: Pioneering the Future of Cell Culture
With the promise of transformative treatments, cell therapies are rising across oncology, regenerative medicine, and stem cell applications. PL BioScience supports this evolution with Human Platelet Lysate (HPL) and soon, the first artificial HPL, while expanding production in Aachen to continue to deliver this high-quality cell culture supplement worldwide.
miRNA discovery & development platform
Pharmahungary Group (PH) developed miRNAtarget, a miRNA discovery software tool based on miRNA-mRNA molecular networks. PH holds patent families on 4 cardio-protective microRNAs families (protectomiRs) and seeks for co-development partners and/or early stage investors. PH also offers its miRNA discovery and development service platform that includes efficacy testing from in vitro to large animal models in various therapeutic areas.