Manufacturing
Under the interim policy, officials do not intend to take action against sites that produce the peptides.
In this episode of Denatured, you’ll hear from Jerome Barley, commercial director at Avion Medical and Ryan Klein, vice president, business development, US and APAC at Resolian. We discuss why Australia has become a magnet for early clinical development, and whether its speed, regulatory clarity and tax incentives are pushing it toward a more integrated biotech role.
As companies invest billions of dollars to reshore manufacturing, 10 biotech and pharma businesses are reportedly trimming staff at manufacturing locations in 2026 or the coming years, with BioNTech having the deepest cuts.
The FDA has outlined a process for allowing a single application to cover multiple variants of a gene therapy. At the same time, the Centers for Medicare & Medicaid Services has revealed plans to expand the Cell and Gene Therapy Access Model to increase patient access to these products.
CROs cite faster startup timelines, regulatory predictability and tax incentives as reasons for growing interest in Australia. State investments in manufacturing, translational research and advanced therapies aim to expand that advantage into a broader biotech ecosystem. The question remains whether Australia can support drug development at broader scale.
Following the withdrawal of billions of dollars in investments from Boehringer Ingelheim and Eli Lilly, German lawmakers have proposed a clause to the country’s healthcare reforms set to take effect Jan. 1.
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.
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